Before CCRPS Maria Lopez was an experienced physician with a background in medical devices, looking to expand her role within clinical research. After CCRPS Maria ascended to the role of Chief Medical Officer at a CRO in Columbia, specializing in medical devices, significantly enhancing her expertise in clinical research operations.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Maria's insights provide a profound view of the impact that the CCRPS certification program has had on her professional capabilities and her organization's services.

Key Takeaways

● Maria appreciated how the course was structured, which allowed her to develop a deep understanding of clinical research administration, particularly in the context of medical devices.

● The inclusion of templates and structured guidance within the course enabled Maria to streamline her workflow and implement standardized procedures at her CRO.

● The focus on quality and safety in the course resonated with Maria’s values as a physician, empowering her to uphold high standards in her organization's research practices.

Recommendations to Colleagues:

● Maria strongly recommends the CCRPS course to her peers, emphasizing its comprehensive coverage of clinical trials, its practical utility, and the continuous access to updated content, ensuring that learners stay informed of the latest industry standards and regulations.

Career Advancement:

● The CCRPS certification was pivotal in Maria’s promotion to Chief Medical Officer, where she now plays a crucial role in expanding her company’s services to include clinical research for medical devices, demonstrating the direct career benefits of the program.

Insights for Future Improvement:

● Maria suggested enhancements to the course, including more interactive teaching methods beyond slide reading and better follow-up on participant inquiries to strengthen the learning experience.

@0:00 Courtney Fulkerson: "All right. First of all, thank you for meeting with me today and we're pretty much just going to kind of go through some questions and get your feedback on the program and things that you like about it, things you didn't and pretty much just to tailor the program from here on out like any feedback."

@1:15 Maria Lopez: "It was really important for me, the part where we're at it. I mean, you usually know the basics of the history of political research, but it was like a really wide and long, it gave me a lot of information about it in a timeline. It was many things I didn't know. And now I have a wider structure about it. It was really from the beginning was like, wow, they usually go really fast through ethics, but it was really important."

@2:30 Maria Lopez: "The other thing that I loved is you gave us a lot of templates and for example, letter structures, then you can start using them that when you now have a file of papers that I don't have to have a changed name, the log. Oh, I've got a little bit more of my devices, but not only the knowledge, but now have a lot of papers that are always ready to start going on. So that is that was amazing. That is the, this is the only course I ever done that I really find that those many times and stuff."

@3:45 Courtney Fulkerson: "Yeah, it's good to hear just any really point of view. And I feel like as long as it was useful and you're able to kind of talk about like the way you've been able to use it, which I know you have a little bit, but we're grateful for any feedback."

@4:50 Maria Lopez: "I was really interested in quality that is like the main thing we are really into it. So quality was when I read what I went over the course, me and my boss, we were ready. It was like, OK, we need this to be like really into quality. Because our CRO, we all of us, I mean, our doctors, we're all physicians, basically, we're physicians. So all everything around quality and safety, it's really important."

@6:10 Courtney Fulkerson: "Right, that's very, I mean, it's important. It's important in anything. But I mean, that's not too good that you found that within our course."

@7:22 Maria Lopez: "You know, me as a non, I mean, I speak my native language Spanish and Sometimes you get into those programs and you have many accents that are so hard, but you didn't. That was really good. I understood like everyone."

@8:55 Courtney Fulkerson: "Good."

@9:10 Maria Lopez: "I'm definitely coming back. I didn't download everything. And I just got it there. And the topics that I feel like not very strong, I've listened to them. Not like starting for the exam, but like listening to it. we were a podcast, listening to them and really getting into them."

Before CCRPS: Hannah Fischer Was A Grant Manager Struggling with Clinical Trial Coordination. After CCRPS She Elevated to Clinical Trial Leader at UCSF, Excelling in Trial Management and Grant Applications, Thanks to Our Clinical Trials Training.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Hannah Fischer’s feedback underscores the significant positive impact of the CCRPS certification program on her professional life. Her experience highlights the program’s effectiveness in enhancing participants' understanding of clinical trials, improving job performance, and facilitating career advancement. This testimonial serves as a strong endorsement of the program’s value to professionals in the clinical trials industry.

Key Takeaways

● Hannah had a very positive experience with the self-paced online format, which she found accommodating to her busy schedule.

● The content was comprehensive and directly applicable to her current role in managing clinical trials, significantly aiding her daily responsibilities and strategic approach.

● Successfully leveraged course content and certification to secure a promotion at work, underscoring the practical benefits and career enhancement potential of the program.

● Enthusiastically recommended the course to colleagues due to its thorough coverage of clinical trials from start to finish.

Career Advancement:

● The certification and the knowledge gained from the course played a crucial role in Hannah securing a promotion at work, illustrating the career enhancement potential of the program.

Course Structure and Content:

● She appreciated the self-paced online format, which was perfectly suited to her busy schedule, allowing her to integrate learning seamlessly with her professional responsibilities.

● The course provided a solid foundation in understanding clinical trials from start to finish, making complex processes understandable and manageable.

@0:00 - Courtney Fulkerson: "Congrats on successfully completing your CCRPS program, and thank you also for taking time to meet with me today. We're pretty much just going to go through some questions and answers just to have a conversation about basically how we can improve the program and then your experience with it and kind of where you're at right now in your professional career. Alright, and if you're ready, we'll go ahead and get started with some questions. Okay, could you share some of your favorite moments from the course that enriched your learning experience?"

@0:48 - Hannah Fischer: "I think that's very beneficial. It would be fun to think about, you know, what is needed in the workplace. It helped me. I worked in grants, so I'm the grant program manager for our department, and we are starting a clinical trial for one of our products. I didn't necessarily have a strong engagement and understanding of how everything works together. I have little pieces; I've done this before, but being on the grant side, having this understanding really helped me put together our new grant, our OC2 grant together, and also trying to help implement this trial with some of the events."

@1:35 - Courtney Fulkerson: "Right, well that's really good to hear. What sort of program were you looking for when you chose CCRPS and were you pleased with the content of the course once you got started?"

@2:12 - Hannah Fischer: "I was looking for something that fit my schedule, had a very busy schedule with us, so when I was looking I was looking for something that was self-paced, but also something that had a good foundation, so it explains everything from start to finish about what all is involved in clinical trials, so that it's not too overwhelming."

@4:12 - Courtney Fulkerson: "Would you consider revisiting the course for a refresher, and is there any specific information that you'd want to see within a refresher course?"

@4:25 - Hannah Fischer: "Yes, I can see how that could help with my job in clinical research. Integrating real-world scenarios would be helpful, just because it's nice to see how this knowledge is applied in the workplace."

@4:50 - Courtney Fulkerson: "And if someone from our program were to ask for recommendations for future editions, such as the 2025 edition coming up, would you be open to sharing a list of recommendations and potentially being featured as a course contributor on a future edition of the course?"

@5:05 - Hannah Fischer: "Absolutely. I'm all for continuing education and helping others. If I can help anyone, please let me help."

@5:19 - Courtney Fulkerson: "Can you share what factors motivated you to choose this course and how it stood out from other options that you might have considered?"

@5:41 - Hannah Fischer: "I was looking for something that was self-paced because of my busy schedule. I needed something that provided a thorough foundation, explaining clinical trials from start to finish, so it matched my needs well. CCRPS offered that, and it was easier to fit it into my schedule."

@6:02 - Courtney Fulkerson: "Great, it checked all your boxes then. Now, can you share about your professional journey prior to embarking on this course and how you envision the course contributing to your career growth?"

@6:26 - Hannah Fischer: "Yes. Before taking this course, I was involved in clinical trials administration and coordination but needed a deeper understanding to write clinical trial grants successfully. The comprehensive nature of this course really helped me improve my understanding, which is crucial for my work in managing grants and coordinating trials."

@7:01 - Courtney Fulkerson: "How long did it take you to complete the course and do you feel like the duration was adequate for your learning?"

@7:14 - Hannah Fischer: "I worked on it periodically over 2-3 months. It could be completed in 1 month if someone focused fully on it. The pace was good — the content was clearly explained and I didn't feel rushed."

@7:45 - Courtney Fulkerson: "After completing the course, how did you update your resume and enhance your professional profile?"

@8:06 - Hannah Fischer: "I added the CCRPS certification to my resume and LinkedIn profile. It gave me credibility and deeper knowledge that set me apart in my field. It's definitely helped in job interviews and discussions within my professional network."

@8:36 - Courtney Fulkerson: "How would you describe your experience with our learning platform? Did it facilitate a smooth and engaging learning process?"

@8:48 - Hannah Fischer: "The platform was easy to navigate and use. The content was accessible, and I could go back to review material as needed, which was very helpful for reinforcing knowledge."

@9:35 - Courtney Fulkerson: "And finally, what part of the course did you find most engaging and beneficial to your professional development?"

@9:48 - Hannah Fischer: "The quizzes were particularly helpful for reinforcing the material. The final exam was also very beneficial as it forced a comprehensive review of everything covered, which solidified my understanding and confidence in the subject matter."

@10:23 - Courtney Fulkerson: "What are some reasons you would recommend this course to others based on your experience?"

@10:30 - Hannah Fischer: "It covers clinical trials thoroughly from start to finish and is helpful for anyone involved in clinical trials. I've recommended it to colleagues because it provides a solid foundation and understanding of the clinical trial process, which is essential for anyone in this field."

@10:44 - Courtney Fulkerson: "And lastly, could you share how your career has advanced since completing the course?"

@10:58 - Hannah Fischer: "Since completing the course, I've been promoted at work. The knowledge I gained through the CCRPS program directly helped me secure a higher position where I now manage more critical aspects of clinical trials. It's been a significant boost to my career."

Scott Boyle's Professional Advancement with CCRPS GCP Certification: From Intern at a CRO to Regulatory Affairs Specialist at UPenn

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Scott Boyle’s feedback underscoring the effectiveness of the GCP certification program in providing essential knowledge and skills for professionals transitioning into or advancing within regulatory affairs. His suggestions for bundling courses and adding detailed workflows indicate areas for potential enhancement that could benefit future learners. Overall, Scott’s experience with the course was highly positive, significantly impacting his professional development and career progression.

Key Takeaways

● Scott found the course straightforward to navigate and access, appreciating the professionalism of the website and the reasonable pricing.

● The self-paced nature of the course was beneficial, allowing Scott to fit the learning into his schedule effectively.

● The course content, especially the Code of Federal Regulations section, was directly applicable to Scott’s job in regulatory affairs, enhancing his confidence and competence.

● Completing the course helped Scott secure a job in regulatory affairs, attributing his success in part to the confidence gained from being GCP certified.

Content Satisfaction:

● The course covered essential GCP elements that were crucial for Scott’s role, particularly the detailed information on regulatory requirements which he found most engaging.

Learning Platform:

● Scott praised the learning platform for its user-friendliness and the ability to revisit the content anytime, which he found helpful for continuous learning.

@1:00 - Courtney Fulkerson:
"You're looking to get a certification or like what made you choose this specific one?"

@1:05 - Scott Boyle:
"It was exactly GCP. It was a great refresher learning course. It wasn't required as part of my current job now. They made me redo my GCP. But overall, I think it was a great refresher and it did help me prepare for my current job now."

@1:37 - Scott Boyle:
"I think maybe if there was like a bundle, like I could do like a GCP and a CRA kind of thing."

@1:48 - Scott Boyle:
"Combining two courses, yeah, because I would say some of them can definitely go hand in hand and others could definitely, I mean, all together work out pretty good."

@2:07 - Scott Boyle:
"So I currently work in regulatory affairs at UPenn. Maybe if there is a regulatory aspect of it, I'm a regulatory affairs specialist. Yeah. could be like a like a workflow process kind of thing like this is how every day is going to work for generalized regulatory affairs specialists. And then once you go to a company, it can vary depending on company policies."

@3:20 - Scott Boyle:
"And is there anything that you would like to see within that if you were to? I already have. I already went on the website recently, and I was just reading through it again about processes. again, the CRF, Title 21, overall, I'd say it was good taking class and what I like most about it is in my account. I can still go back or refer to it whenever I want. I like how it's a one-time thing, and there's not blocked by a bunch of different day walls."

@5:05 - Scott Boyle:
"Yes, I would."

@5:41 - Scott Boyle:
"Um, I would say the website looked the most professional out of all. And the GCP course was reasonably priced at very easy to access. I mean, I think it was like two Google searches and I got right there."

@6:02 - Scott Boyle:
"I do do others, but I think overall it was easy to use. It was very open with what you offered. And I think it was pretty fairly priced at $50."

@6:26 - Scott Boyle:
"So before I took this, I did an internship at a CRO company. And they were talking all about GCP and ICH. And it encouraged me to go out and get the certification. I just didn't know where to go. And going back to the same thing, as I said before, it was very easy to go to Google found this organization right away. And they gave me a pretty informational course and a certification to go along with it. that was very helpful."

@7:27 - Scott Boyle:
"Yeah, I loved that with self paste."

@7:45 - Scott Boyle:
"And then how has it enhanced your professional profile? I would say is it has helped me get my current job now. GCP certified on my resume, and then I even put it on my LinkedIn. And I have I noticed more people requesting to follow me in clinical research because they see some of my credentials."

@8:17 - Scott Boyle:
"I would say it overall was very good because like you said again, it was self-paced and there was an option to, if people wanted to, can like read faster, you could have the person reading speed it up to like times two or times five. That was a good process."

@9:35 - Courtney Fulkerson:
"Good. I'm glad that that made you feel confident and I feel like that is one of the biggest parts of clinical research so it's always good to know."

@10:30 - Scott Boyle:
"The top reasons I'd say is easy to navigate, you make your account, you pay a one-time fee, and then you can always go back to it, which I think is very, very good."

Justin Scott Brathwaite's Career Growth Through the CCRPS Coordinator Course Justin Scott Brathwaite advanced from a Startup Associate to a Senior Startup Specialist after completing the Clinical Research Coordinator course offered by CCRPS.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Justin Scott Brathwaite’s feedback emphasizing the course's strengths in providing comprehensive, relevant content at an affordable price. His career advancement post-course completion serves as a testament to the program's effectiveness in equipping participants with the necessary skills and knowledge for professional growth in clinical research.

Key Takeaways

● The broad knowledge gained from the course has bolstered Justin's confidence, particularly in his ability to understand and manage different roles within clinical research. This is pivotal as he aims to move into a project management role, indicating his readiness to handle more complex tasks and leadership duties.

● Since completing the course, Justin has advanced from a Startup Associate to a Senior Startup Specialist, and he is now taking on responsibilities related to project management. This progression demonstrates the tangible impact of the course on his career trajectory.

● Justin's willingness to recommend the course to others, especially due to its comprehensive content and affordability, underscores his positive evaluation of the program's value. This recommendation reflects his belief in the course's ability to provide foundational knowledge essential for newcomers to the field or those seeking a cost-effective way to enhance their skills.

● Justin's participation in the CRC course significantly improved his grasp of critical aspects such as regulatory standards, ICH guidelines, GCP, and SIV. This comprehensive understanding is crucial for his role in study start-up and aids in his professional efficacy.

Course Value and Effectiveness:

● Justin praised the course for being comprehensive and cost-effective. He found the focus on site perspectives particularly enlightening as it aligned with his work in Startup Associate to Senior Startup Specialist..

Content Relevance:

● The sections on regulatory standards, International Council for Harmonisation (ICH) guidelines, Good Clinical Practice (GCP), and Site Initiation Visits (SIV) were highlighted as the most relevant and beneficial, directly aiding his professional duties.

@0:00 - Justin Scott Brathwaite: "Hey Courtney, how are you?"

@0:27 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "That's perfect. I'm just going to start recording on Zoom as well."

@0:39 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "How are you today?"

@0:40 - Justin Scott Brathwaite: "Doing well."

@1:42 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Could you share some of your favorite moments from the course that enriched your learning experience?"

@1:49 - Justin Scott Brathwaite: "Yeah, I took the clinical research coordinator course. I work in study startup and it was really helpful to understand the coordinator's role since I do a lot of work with sites. I found the SIV, ICH, and GCP sections particularly helpful."

@2:45 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "So it was pretty comprehensive. Good. So you feel like it kind of covered a lot of bases and it was able to translate into what you’re doing now."

@3:10 - Justin Scott Brathwaite: "I was looking for something that was relatively cost-effective and also up to date to expose me to the material. I needed something comprehensive. That's kind of why I chose the program."

@3:59 - Justin Scott Brathwaite: "The content was really good. It was just that sometimes the narration was a bit rushed."

@7:13 - Justin Scott Brathwaite: "I would consider revisiting the course. I think I would do a refresher. I'm thinking about doing the PM one because I just saw there was a project manager course."

@11:00 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "It gave you a little bit of background on the site side of things, I think."

@14:52 - Justin Scott Brathwaite: "The regulatory, ICH, GCP, SIV sections were the most relevant because I deal with a lot of regulatory in this position so it's kind of helped me to leverage that to work with sites."

@16:13 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "And what are some reasons that you would recommend this course to others based on your experience?"

@16:28 - Justin Scott Brathwaite: "I think it's a pretty comprehensive course. The content is there. I think it's especially good for people on a budget."

@17:37 - Justin Scott Brathwaite: "No problem. Thank you, Courtney. Thanks for having me."

Unber Mahmood's case study interview about her experience with the Clinical Research Coordinator (CRC) certification program February 2024 Graduate

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Unber Mahmood's case study reflecting a highly positive experience with the CCRPS's Clinical Research Coordinator program, which not only met her educational needs but also supported her professional growth in the clinical research field. Her feedback provides valuable insights that can help in refining the program further, particularly in enhancing the visual and interactive components of the course.

Key Takeaways

● Unber particularly appreciated the self-paced aspect of the course, which allowed her to balance her responsibilities as a mother and a professional without feeling overwhelmed.

● The course provided all the necessary basics and details needed for a thorough understanding of clinical research, comparable to on-the-job training.

● The availability of instructors for queries and the interactive nature of the platform were crucial in assisting her whenever she encountered difficulties, contributing to a positive learning experience.

● Her motivation to enroll stemmed from a need for a flexible, affordable, and detailed-oriented course that could provide her with the specific knowledge required for a career in clinical research.

Positive Experience with Course Format:

● Unber emphasized the self-paced nature of the course as her favorite aspect, which significantly reduced her stress by allowing her to manage her learning schedule alongside her responsibilities as a mother and a medical professional.

Course Content and Accessibility:

● Unber appreciated the comprehensive and detailed content that did not skip essential parts despite the course's short duration. The platform offered a variety of courses, making it a one-stop resource for various certifications related to clinical research.

@0:32 Courtney Fulkerson: "How are you? Good. So thank you so much for tuning into this call and first of all, congrats on completing this CCRPS program. We're pretty much just going to take some time to go through some questions and kind of hear your feedback on the program and things that you liked about it, things you didn’t and kind of help us tailor the program from here on now. So once you're ready."

@1:00 Unber Mahmood: "Experience. So when I started this course, the most important and the most my favorite thing is that the course was self-paced."

@1:11 Unber Mahmood: "Yes, that was the best part because as a mom and as already working in the job, when I started this course, I did not feel any kind of pressure doing that course that I had to meet the deadlines or I had to do my questionnaires or I actually enjoyed the course only because it was not giving me any kind of pressure. It was self-paced. It was it gives me a time to read it properly and so this was the main part I really enjoyed doing it."

@1:48 Courtney Fulkerson: "Yeah, we get a lot of good feedback on the self-paced portion of it so it definitely helps."

@1:55 Unber Mahmood: "I was in a program where you're looking for when you chose CCRPS and where you pleased the content once you got started. Actually, when I started, I was already working in over-hospital, actually I'm a foreign medical doctor, and I'm already working in a Fairfax hospital. But I always have an interest in clinical research, and because when I was in my university also, I participated in one of the researches with my senior doctors."

@4:00 Courtney Fulkerson: "And looking back, is there any aspect of the course that you feel could have been enhanced to make the learning experience even more rewarding?"

@4:12 Unber Mahmood: "Actually, at some point, I didn't think that it should be, but most of the part was okay, but I think if there was more of a, you know, the drawings part, you can say?"

@4:30 Unber Mahmood: "Because for me, I don't know for other people, like for me, if I'm reading something and it's with the drawings and it's with the charts or it's with the, it becomes more interesting to read to just, to just like prevent that, oh, it's boring just to read the same, just to read the lines. But overall, but it, I don't feel like more often, but yeah, that you could enhance, but if you don't do it also, it's okay."

@6:05 Courtney Fulkerson: "It was the actually the whole website to navigate is very easy."

@6:10 Unber Mahmood: "Like, this is the actually that's the first step. Anybody could actually get attracted to CCRPS because the website itself is very easy to understand. As soon as you open the website, even still, I think I’ve done my course like a little bit in the past. But even still, if I wanted to repeat something, if I wanted to remind something in my in my course, I just sign in, I just go back to my course and just read it again, you know, just to make it understand. So the website itself is very easy. It's just you just see it on the first front page too. It's very easy to navigate to sign in to make your username, password and everything. So it's very easy."

@7:39 Courtney Fulkerson: "Would you ever consider revisiting the course for a refresher? And is there anything specific you want to see within a refresher course?"

@7:47 Unber Mahmood: "In the, um, the refresher course, just keep it self-based."

Celina Moon took the Clinical Research Coordinator (CRC) certification course provided by CCRPS, with a focus on ICH GCP to support her career transition into clinical research.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Celina Moon's feedback provides valuable insights into the strengths and areas for improvement within the ICH GCP course. Her suggestions for more interactive and engaging content delivery, along with the inclusion of practical examples, could enhance the learning experience for future participants, especially those new to the field. Her positive assessment and the constructive criticism will be instrumental in refining the course to better meet learner needs and expectations.A graduate case study interview from Celina, a recent graduate of our ICH GCP course program.

Key Takeaways

● Celina found visual aids such as graphs, tables, and bullet points extremely helpful for her learning style, emphasizing the importance of visual elements in grasping complex information.

● She appreciated the ability to download course materials for future reference, suggesting it added significant value to her learning experience. However, she recommended including real-world documents like informed consent forms to better anchor the theoretical knowledge within practical contexts.

● The course notably boosted Celina’s confidence, reaffirming her decision to transition into clinical research. She found the adverse event/safety reporting section particularly valuable, highlighting the ethical treatment of human subjects, which resonated with her professional values and goals.

Favorite Moments:

● Celina appreciated the course's use of visual aids and the right-hand community feedback section, which helped preview and reinforce key points, aiding in her understanding and retention of course material.

Course Content:

● She was looking for an ICH GCP course to support her career change and found the course's depth and detail both adequate and informative.

Impact on Professional Confidence:

● Completing the course significantly boosted Celina's confidence in her ability to transition into and succeed in the field of clinical research. The course reassured her about her career change and enhanced her understanding of the ethical treatment of human subjects, which was crucial for her professional identity and values.

@2:15 - Celina Moon: "Yes. So what I really actually enjoyed is the parts on the slide that were set up in graphs and tables and bullet points. It just makes a lot more sense to my brain."

@4:39 - Courtney Fulkerson: "That's actually the first time I've heard such good feedback about that part."

@3:17 - Celina Moon: "And I also really liked that on the right-hand side... there was an opportunity where as a learner, I could have put my feedback and some other students kind of did a similar thing, kind of like a cliff notes version."

@3:57 - Courtney Fulkerson: "Those are a couple of features that I thought were really, really neat."

@4:07 - Celina Moon: "The way my brain works is it's very much how the pieces are sitting into the puzzle... And then as I heard all these details, I knew what part of the puzzle was fitting into with that."

@10:06 - Celina Moon: "Yes. So I am very passionate and working very hard for a career pivot... My mom has worked in the field for 25 years and she was one that recommended this course."

@5:59 - Courtney Fulkerson: "And so you got in, you liked the content and just you felt like it was adequate to what you were trying to learn?"

@6:32 - Celina Moon: "It was more. It wasn't more than I expected, but... it helped me gain a better grasp of what I'm getting into."

@31:25 - Celina Moon: "I would definitely revisit it. Like I said, as I already found it, like I was excited, I downloaded the information."

@16:33 - Courtney Fulkerson: "So I'm glad you had a good experience."

@30:24 - Celina Moon: "Oh, I would definitely choose to take it again."

@22:25 - Celina Moon: "Yes, it actually did boost my confidence because at first... And then, you know, I took a deep breath and I started over and, you know, maximum attention, I was like, no, I do get it."

@33:42 - Courtney Fulkerson: "And any input is good input, like I said earlier, so it will help us just refine the course for the future and just meet your graphic. I really appreciate you and I wish you the best of luck."

@33:46 - Celina Moon: "Oh, thank you. I appreciate you too."

Stephanie completed the ICH GCP certification course offered by CCRPS, aiming to build a solid foundation in Good Clinical Practice as she pursued a career in clinical research.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Stephanie’s feedback underscores the effectiveness of the ICH GCP course in providing a solid educational foundation in Good Clinical Practice. Her suggestions for technical improvements point to areas where the course could be enhanced to ensure clarity and engagement for future participants. Overall, her positive experience and the tangible impact on her career trajectory demonstrate the value of the course in preparing graduates for professional roles in clinical research.

Key Takeaways

● Stephanie found the course content comprehensive, providing a good foundational knowledge of ICH GCP, which is crucial for anyone entering clinical research. The video format was highlighted as particularly effective for following along and understanding complex topics.

● The end-of-video exercises were highly beneficial for applying theoretical knowledge to practical situations, enhancing the learning experience by tying concepts to real-world clinical research scenarios.

● Completing the course significantly boosted Stephanie’s confidence, particularly in job interviews, and was instrumental in her securing a role as a research assistant. She specifically found the informed consent section thoroughly beneficial, which directly contributed to her professional capabilities.

Overall Impressions:

● Stephanie appreciated the structured breakdown of the course into distinct topics and categories, which made the content accessible and easy to digest.

Course Format and Accessibility:

● The course’s pacing and structure (divided into 30-60 minute video segments) were well-received, making it manageable within a busy schedule.

Impact on Professional Development:

● The certification added significant value to Stephanie’s resume, enhancing her credibility in the field of clinical research and aiding in her career advancement.

@0:00 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "This meeting is being recorded. Thanks for being here today and sharing your experience with the program. Congrats on finishing it!"

@1:00 - Stephanie: "We didn’t have a course specifically for ICHGCP, and it was really good to get an introduction to how it works and procedures. I liked that it was in video form, which was easier to follow along than just slides or articles."

@1:52 - Stephanie: "At the end, they had those little exercises that you could do. It helped me apply the knowledge that I was learning in a more practical sense and get a sense of how this could be used in the clinical setting."

@2:25 - Stephanie: "I was looking specifically for ICHGCP and something that could help me get certified. I felt that it covered every aspect of GCP and was up to date."

@8:30 - Stephanie: "I added it as a certification in my resume, and I feel it enhanced my profile. It helped make me more credible as someone going into the clinical research field."

@9:17 - Stephanie: "I found the platform was very easy to follow. It was straightforward, and everything was in order, which helps you know exactly where to go and what to do."

@10:14 - Courtney Fulkerson: "What part of the course did you find most engaging and beneficial to your professional development?"

@10:24 - Stephanie: "I really liked learning about informed consent because they went into a lot more detail than I expected."

@11:10 - Stephanie: "I would recommend it because it's self-paced, accessible, and the content is straightforward. It's really good for beginners or even just people who are trying to refresh their memory."

@12:57 - Stephanie: "Thank you. It was really nice speaking to you."

@12:59 - Stephanie: "Thank you. Bye-bye."

Marta Marszalek completed the CCRPS certification course, seeking to deepen her theoretical knowledge and practical skills in clinical research to complement her monitoring activities and comply with industry standards.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Marta Marszalek's feedback underscores the strengths of the CCRPS certification course in the self-paced learning and its adaptability to individual needs. Her constructive suggestions for enhancing lecture delivery and incorporating practical examples provide actionable insights for course developers. Overall, her positive experience and the tangible benefits she derived in terms of career advancement highlight the course's effectiveness in equipping professionals with the necessary skills for clinical research roles.

Key Takeaways

● Marta appreciated the self-paced nature of the course, which allowed her to organize her learning schedule to fit her personal and professional commitments.

● The course significantly boosted Marta’s confidence and prepared her for career advancement, leading to more job offers and enhanced professional credibility.

● The minimalist and visually engaging platform was noted for facilitating a smooth learning process, aligning well with her preference for a straightforward and distraction-free interface.

Overall Impressions:

● Marta found the course well-structured and accessible, particularly valuing the ability to learn independently while having access to external support.

Learning Enhancements:

● Marta appreciated the self-assessment opportunities, which helped identify areas that needed review, although she highlighted the monotonous delivery of some lectures as a point for improvement.

Course Format and Accessibility:

● Open to contributing as a course advisor, Marta is willing to provide recommendations to enhance future editions of the course, reflecting her vested interest in the continuous improvement of the curriculum.

Impact on Professional Development:

● Adding the certification to her CV and LinkedIn profile significantly increased her marketability and helped secure new job opportunities, affirming the practical benefits of the course.

@3:24 - Marta Marszalek: "Probably when I finished, when I started the test, and it was all positive. But actually, I also like the moments when I was not passing this self-evaluation test. And then I knew which part I have to go back, which part I have to go back and learn again. But actually, now I have to say that the most exciting was the beginning, because you know, you are starting with something new."

@4:22 - Marta Marszalek: "Well, it was actually exactly what I was looking for. So because I wanted to find the course that I could learn by myself, but with some external help. So for me, it was important to see the presentations and to find the speakers going through the presentations. So that was what I was looking for. And of course, the certificate gates were important."

@5:00 - Marta Marszalek: "The learning experience, even more rewarding? Like one thing I would consider as a possibility to improvement would be like the lectures but the lectures that were reading the slides. So first it would be better if they just don’t read everything."

@6:26 - Marta Marszalek: "No, I think it was covered pretty much well with theoretical parts. Maybe some like cases would be nice to include. I always like to see with the tests or like evaluations. So you can see like the case and you can evaluate what’s what’s wrong with this one, where’s the mistake or something like that."

@7:26 - Marta Marszalek: "Yes, I think the courses is prepared very well. It’s not very expensive, so it’s very good. I think it can be even more expensive if you can offer more things because people So I think with some improvements I think it could be more expensive but also so, um, the marketing of your, uh, the course is like, it’s, um, it’s not very well, uh, shown. Like, yeah, I think you can show more from the, uh, what you can get from the course."

@8:33 - Marta Marszalek: "If I want to do a refresher course. Yeah. Yeah, definitely."

@10:36 - Marta Marszalek: "So in my case, I needed the certificates to obtain the certificate in very fast, in very fast way. so lots of courses, they would tell you how many hours you can do per week or they are already organized. But in this case, I knew that I would sit. a few days, 10 hours straight, and I can do it. for me, with the flexibility to organize your learning time and schedule, that was very important and the easiness to do this course."

@11:57 - Marta Marszalek: "So I was already working in clinical training. class when I, in the first one, that was, I was not doing, like, strictly monitoring activities, but I was collaborating also for monitoring visits, and for the compliance reasons, I needed the certificate, and I wanted to learn more because I knew the practical parts, and some theory as well, but it’s different when you have to refresh everything and you have to do, it’s like master and with any kind of studies that we’re doing, so in my case it was necessary. I can say I’m not sure if this is because of the certificate or different reasons, but I do receive a lot of offers, job offers, including, for example, yeah, and I’m sure it’s a great value to add to your CV."

@14:00 - Marta Marszalek: "Definitely very easy. That was also one of the reasons that I chose because I was playing with platforms and I’m very like visual person so I need to see that it was simple. It was not like very distracting. I don’t like it but to my images colors and it was very easy. I’m a minimalist person so it’s easy to open it to get there and it was also nice that when you were entering the platform it was you were going to when you left it."

@15:13 - Marta Marszalek: "Basically, what I just said, I think it’s very good for people that they are self-discipline. They like learning new things or they like refreshing things. I think people who are also like challenges, so that’s why you are doing courses when you get some certificate games, it’s always like... Engaging you more in learning something new. Okay. Yeah."

Katie Decker completed the CCRPS certification course, aiming to bolster her extensive practical experience in clinical research with formal training. This certification enhanced her professional profile by validating her knowledge and skills, aligning with industry standards, and preparing her for advanced roles in clinical research.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Katie Decker's feedback from the CCRPS certification program highlights the effectiveness of the course in reinforcing and expanding her knowledge in clinical research. Her suggestions for incorporating more interactive elements and enhancing the marketing of the course's flexibility are valuable insights that could help improve the learning experience for future participants. Overall, her positive review and the tangible benefits she has experienced in her career underscore the value of the CCRPS program in professional development.

Key Takeaways

● Katie appreciated the self-paced online format, which allowed her to manage her learning alongside work commitments efficiently.

● The certification significantly boosted Katie's confidence and enhanced her resume, making it more compelling to potential employers.

Course Experience and Content:

● Katie enjoyed the accomplishment of completing the course and obtaining her certification. She valued the course as a good refresher on research basics and appreciated learning new aspects of clinical research.

Motivation and Outcomes:

● Choosing the course for its self-paced format, Katie needed a certification that could be completed alongside her job without requiring a degree. The course fulfilled these requirements and prepared her for career advancement.

Engaging and Beneficial Course Aspects:

● Taking exams and realizing the depth of her knowledge was particularly satisfying for Katie, reaffirming her competence in her field.

@0:00 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "This meeting is being recorded. Sorry, let me make sure everything. Okay. I think we're good to go. All right. Well, first of all, thank you so much for meeting with me and congrats on completing the CCRPS program."

@0:41 - Katie Decker: "Definitely completing the course, obviously. I worked in research for like seven years now. So it was kind of cool to have like a refresher on the basics and also kind of learning a couple new things here and there. But definitely just completing the course is very accomplishing."

@1:04 - Katie Decker: "Um, so I actually my employer signed me up for the class and everything. Um, originally I worked for a different employer and they were going to have me... I don't know the name of the program, but it was where I actually had to sit for an in-person exam... Um, so this wasn't what I was expecting when I first started the classes and I loved that it was online and kind of self-paced. So, um, it was super like user friendly and very easy and convenient with my work schedule to do."

@3:54 - Katie Decker: "Yeah, definitely. It was nice because I could do it at work and like in between patients kind of hop on and do a couple pages."

@4:10 - Katie Decker: "Definitely. I think for a refresher course, it's always good to kind of refresh on documenting AEs and SAEs and the informed consent process."

@8:19 - Katie Decker: "So I did add the certification on to my personal resume, and then I have a LinkedIn profile and also Indeed. So I have like a picture of like the actual certification with a little serial number and everything on there."

@8:44 - Katie Decker: "And yeah, definitely. And it's nice to when you can, like, if your computer locks or whatever, when you log in, it just brings you right back to where you are, which was really convenient."

@9:00 - Katie Decker: "since ankle and a core research. I just think overall it's just nice to have any kind of extra certification or like a document under your belt... So like for me, like they just called me a coordinator, which I know it's still the same thing. But now I have like the ACRC like my signature and all my name tag, which is nice. So it kind of, you know, always a confidence boost."

@9:32 - Katie Decker: "And this might sound weird, but I guess kind of just taking the exam was kind of just nice like, Oh, I know that. It's easy. the answer to that's so easy. So it kind of just makes me like realize what, wow, I actually do kind of know more of what I'm doing."

@11:03 - Katie Decker: "I think it kind of helps me like be more motivated to go back to school. Eventually, I do want to be a CRA. So I think it's just kind of nice just with already being coordinated for so long. Just having that kind of like title now, like credit it, kind of versus coordinator. It kind of just helps boost my career. It kind of like just makes my resume a little more beefy or two and helps boost my knowledge."

@11:44 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Thank you. I'll send you an email or go get email with your gift card for doing this with me and it should just come through email. But if you have any problems, just definitely reach out to me."

@11:58 - Katie Decker: "Have a good day. You too."

Aishwarya Sukumar completed the CCRPS certification course to enhance her understanding of FDA regulations and adapt to the clinical trials industry in the United States after relocating from abroad. This certification broadened her professional scope, solidified her theoretical foundations, and equipped her for higher positions within clinical research, transitioning from a Clinical Research Coordinator to a Clinical Research Associate role.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Aishwarya Sukumar's feedback underscoring the CCRPS certification program's effectiveness in accommodating diverse learning needs while suggesting areas for enhancement such as increased practical engagement and better support systems. Her progression in her career illustrates the tangible benefits of the course, advocating for its value in professional development within clinical research.

Key Takeaways

● Aishwarya appreciated the self-paced online format which provided the flexibility needed to balance her studies with personal responsibilities.

● The course significantly boosted her confidence, enhanced her resume, and equipped her with the knowledge necessary to progress in her career from a CRC role to a CRA position.

Course Format and Learning Experience:

● The self-paced nature and extended timeline allowed Aishwarya to effectively manage her study schedule without compromising her responsibilities as a new mother.

Motivation for Course Selection:

● Chose the CCRPS program for its affordability and flexibility, crucial as she was adjusting to new motherhood and transitioning careers in a new country.

Professional Growth:

● The course facilitated a smooth transition into the clinical research field in the U.S., providing her with necessary certifications and boosting her credibility in job interviews.

@0:03 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
"This meeting is being recorded."

@2:36 - Aishwarya’s iPhone:
"Sure, please go ahead."

@2:38 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
"Could you share some of your favorite moments from the course that enriched your learning experience?"

@2:45 - Aishwarya’s iPhone:
"So the one thing which I would do is the self-paced thing, which is like much easier for homemakers but to choose my own time and I get to study when I... like my energy is full on so I can go ahead and study and focus more so that’s a good part and the other thing is also they though they give you a time frame of three months you can still go ahead and refresh back to your previous texts or other previous chapters in case you have any questions there you can go ahead and check back and then look back to the newest chapter if you can correlate between those two things yeah so that one was an amazing feature and you may take enough time so they say even those three months you can go up to four months and take your own time and understanding each concepts yeah that was a good part there yeah and I feel like you can just make it fit your schedule and your learning style right yeah right..."

@5:09 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
"Okay, good. And looking back, is there any aspect of the course that you feel could have been enhanced to make the learning experience more rewarding for you?"

@5:23 - Aishwarya’s iPhone:
"Yes, I did feel that at one point because I was stuck with a question because I’ve been going through the programs and I was towards the end of the program."

@6:25 - Aishwarya’s iPhone:
"But in a way that I would say that if this could be a support for job or just like even reaching out to a contacts or somebody who can lead on what path you can take next, that would be a great benefit to the program."

@7:53 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
"So no complaints there And when you were considering enrolling was there any specific information? information on our website that could have better highlighted the benefits of the course?"

@10:11 - Aishwarya’s iPhone:
"So, okay. Yeah, I mean, it’s been a while since I’ve been in the course. have to provide that."

@12:37 - Aishwarya’s iPhone:
"So that is always great to hear. Right."

@14:07 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
"Yeah, that’s, that’s always good. And how long did it take you to complete the course?"

@15:09 - Aishwarya’s iPhone:
"So I started updating my resume with all the information which I learned and I also put my certification as in here because I mean I did receive the certification so I did that."

@15:33 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
"And how would you describe your experience with our learning platform? Did it facilitate a smooth and engaging learning process?"

@16:12 - Aishwarya’s iPhone:
"Yeah, in terms of boosting my confidence because I was like in the New Year in the headlights, I didn’t know many things when I started in here and when I learned the course, kind of learned the new terminologies are the acronyms I would say."

@18:57 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
"And now I’m a CRA as well there. It’s awesome, yeah, so I feel like your career definitely has advanced since you completed the course and Apply what you learned from that into Yeah, I mean, yeah, if time permits everyone that one then I can go ahead and check back like just to refresh my memory Yes, well that completes our interview.

Renata Noronha completed the CCRPS certification to transition from pharmacovigilance to clinical research. This certification enriched her understanding of international PV requirements and helped her secure a job at a clinical research organization, advancing her from an associate to a lead safety associate.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Renata Noronha’s feedback providing valuable insights into the strengths and areas for improvement of the CCRPS certification program. Her positive experience and constructive suggestions will be instrumental in enhancing the course structure, content, and delivery, ultimately enriching the learning experience for future participants aiming to advance their careers in clinical research.

Key Takeaways

● Renata appreciated the clear, structured format of the course, highlighting its ease of follow-through which enhanced her learning experience.

● Enjoyed the global perspective on pharmacovigilance (PV) requirements which added valuable insights applicable to her career in clinical research.

● The certification was pivotal in securing her new role at a clinical research organization, aiding her transition from an associate to a lead safety associate.

● Benefited from the self-paced nature of the course, which allowed her to expedite her learning to align with career opportunities.

Learning Experience:

● Found the course modules well-organized and straightforward, aiding her comprehension and retention of information.

Motivation and Background:

● Chose the CCRPS program to facilitate a career shift from pharmacovigilance to clinical research, driven by the course’s specialized focus and comprehensive coverage of necessary skills and knowledge.

@0:59 Courtney Fulkerson: "Okay. Perfect. Great. Could you share some of your favorite moments from the course that enriched your learning experience?"

@1:05 Renata: "Okay, so I think I found that like easy to follow. I liked it was structured. It was easy to follow. And um, I had previous experience in pharmacovigilance. So it was a bit hard for me to understand Like where like what things are there were a few things that were new to me, especially the reporting with uh, different countries."

@2:33 Renata: "So, I was recently let go from my company. They weren't doing well during COVID, and so it was a natural whole product company, so I did pharmacovigilance for them. When I was looking at jobs in my field, clinical trials were one of them. So, I wanted to get more experience regarding pharmacovigilance first, and then I found this program through one of my friends in clinical research."

@2:33 Courtney Fulkerson: "That sounds like it was a really good fit for what you were looking for. It's great to hear it worked out pretty well for you."

@10:16 Renata: "It is certification. yeah. That’s everything."

@10:18 Courtney Fulkerson: "Okay, so that's good. It sounds like the certification was a significant achievement for you."

@11:04 Renata: "Yeah, I think, like, I think I would."

@12:05 Renata: "So I know that what stood out for me was first, it was clinical research and it was a field that I was interested in getting into, it's specialized. That's important to me."

@12:38 Courtney Fulkerson: "Right, it's always crucial to find a course that not only provides knowledge but also aligns with your career goals."

@15:13 Renata: "Yeah, I had to fast track myself because I got a job, so I had to really buckle down. I helped to have a deadline. So I think I started in November, October and I finished in December. I didn't have a Christmas break, I had to finish the course because my interview was at the end of December."

@16:00 Courtney Fulkerson: "That's quite a commitment! It's impressive that you managed to complete it so quickly."

@16:27 Renata: "Yes, so it's good. I finished it because once I started my job, all the clients we have sponsors they all want your resume. Having that on your resume really helps develop rapport with the sponsors."

@21:29 Renata: "Since I've completed the course, I got a job at a clinical research organization."

@21:35 Courtney Fulkerson: "So that's great. It sounds like the course really helped bridge the gap to your new role."

Dr. Vrushali Borawake transitioned from medicine in India to clinical research in Germany after completing the CCRPS certification. This program enhanced her job interview confidence and provided her with key industry knowledge, enabling her to secure roles as a CRC, CRA, and now a project manager. Dr. Borawake recommends this course to international medical professionals seeking careers in clinical research.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Dr. Vrushali Borawake's feedback underscores the CCRPS program's significant impact on her career transition and advancement. Her suggestions for incorporating more interactive learning tools and her endorsement of the program's applicability across different regulatory environments provide valuable insights for future course enhancements. These improvements could further enrich the program's effectiveness in preparing professionals for successful careers in clinical research.

Key Takeaways

● Dr. Borawake successfully transitioned from medicine in India to clinical research in Germany, attributing significant career advancements to the CCRPS courses.

● She secured positions as a Clinical Research Coordinator (CRC) and Clinical Research Associate (CRA), and has recently advanced to a Project Manager role.

● The courses provided her with essential knowledge and confidence, particularly in job interviews, by familiarizing her with industry-specific terminology and documentation.

● Dr. Borawake highlighted the course's effectiveness for international medical professionals seeking to enter the clinical research field in Germany, noting its comprehensive coverage of relevant regulations and practical applications.

Learning Experience:

● Appreciated the structured approach that covered clinical research from start to finish, which was instrumental in her understanding of the field.
● Found the mix of PDFs, videos, and real-document examples particularly beneficial in preparing for real-world applications.

Application of Knowledge:

● The course content directly influenced her ability to perform effectively in her roles, especially with tasks like site suitability forms and other CRC/CRA responsibilities.

@0:01 Courtney Fulkerson: "Okay. Okay. All right. Well, like I said, we're just going to go through some questions. So whenever you're ready, we're going to get started."

@0:13 Vrushali Borawake: "Yeah."

@0:18 Vrushali Borawake: "Sure, basically it has helped me so much that I've got two courses. So initially when I shifted from India, it was, I was a medical practitioner of an alternative medicine. And then when I shifted to Germany, I was getting calls for a partner job, but not for an associate CRA job. So I did the first course for CRA and then a second course for project management and clinical research."

@0:47 Courtney Fulkerson: "That’s awesome. To come back and decide to do another program."

@0:52 Vrushali Borawake: "So that’s really good. Yeah. Definitely. So the first offer I got was from the first course as a CRA and that was an associate. So the second office they were saying we can offer a project manager position as well so that you can learn hands-on while working. And then I thought okay, I start on the post of me. So I thought before I start, I'll just buy again from CCRPS because this course has always helped. So right now I feel I’m fully prepared for the post of me."

@1:24 Courtney Fulkerson: "That’s awesome, yeah. Well hopefully it all works out and hopefully you’re able to use what you learned from the course into your job."

@1:33 Vrushali Borawake: "So that’s really good. Sure, sure, definitely. So coming to your question from the first course, what I liked about what I found very interesting about CRA course that it was from initially into end of the study and not just like considering that you’re already a coordinator and then you’re shifting to associate side. So the first few slides were differentiation between CRC and CRA and I’m not Because everybody knows that. So while working, there is a difference we monitor in coordinator, but it was very well structured."

@2:38 Courtney Fulkerson: "Good. And so you feel like you were able to kind of put that into practice really as soon as you got into the role."

@2:58 Vrushali Borawake: "Yeah, yeah, immediately. Yeah."

@3:01 Courtney Fulkerson: "Good. Okay. And could you share some of your favorite moments from the course that enrich your learning experience?"

@3:07 Vrushali Borawake: "Oh wait. That’s when I just asked you. so sorry."

@3:09 Courtney Fulkerson: "What sort of program are you looking for when you chose CCRPS and were you pleased with the content of the course once you got started?"

@3:18 Vrushali Borawake: "So I would like you to explain a bit to the question."

@3:23 Courtney Fulkerson: "So what kind of program, whenever you were looking to start a program, kind of what were you looking for and how did our program stand out amongst the other ones and kind of like what aspects were you looking to meet your certain criteria?"

@3:38 Vrushali Borawake: "Sure. when I was searching, I was searching for a coordinated course or something. But to be honest, I went, I always go into chat GPT, I went into chat GPT, but what are the best courses for to land a job as a CRE or CRC and CCRPS definitely comes into first fight. So you have the first two I saw were not online so I had to be in the United States to do that, that is not possible and I think the others I don’t remember but the most suitable was CCAT is because of the online schedule, immediate payment and I think it was also a very reasonable amount, it was around 500 euros, $5.20 or something like that and then I decided for that because of online it was self-paced so I could do at home, initially they had given a timeline that if you follow the schedule you can do it in one month or something but I had like seven days to start my job so I took care of this too, it was very interesting the things that I knew I could skip, that’s a good part but not entire course I could skip that is also good part for people who just want to have a certificate it makes us sure that you attend it and The quiz at the end was also good so I finished the course in three to four days but for the quiz I went through the documents once again just to be sure that I pass it. The best and the most important part was the certificate was generated very easily."

Rabiea transitioned from a physician and pharmacologist in India to a confident drug safety physician after completing her CCRPS certification in pharmacovigilance.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Rabiea's feedback highlights the CCRPS program’s effectiveness in delivering comprehensive and accessible pharmacovigilance training. Her suggestions for interactive enhancements and internship opportunities offer valuable pathways for program improvement, potentially increasing the practical applicability of the course for future learners.

Key Takeaways

● Rabiea appreciated the course's comprehensive nature, noting its gradual build-up from basic concepts to more complex topics in pharmacovigilance.

● The ability to re-listen to video modules and access material from any location was highly valued, enhancing her learning flexibility.

● Detailed modules on regulations and the ARGUS safety database provided her with practical skills and confidence, making her feel job-ready.

Program Structure:

● The curriculum's structured approach in covering pharmacovigilance from fundamentals to advanced topics was effective.

Learning Tools:

● Video modules were particularly useful for revisiting complex concepts, ensuring thorough understanding.

@0:00 - Courtney Fulkerson:
"Hello, how are you?"

@0:02 - Rabiea:
"This meeting is being recorded."

@0:04 - Courtney Fulkerson:
"I'm good. I am just going to start recording on Zoom as well."

@0:12 - Rabiea:
"All right."

@0:14 - Courtney Fulkerson:
"Well, thank you first of all for meeting with me and just taking time to share your experiences with our program and really the plan is just to go through a few question and answer, pretty much just a conversation of your experience with the program and maybe where things can get better, where you, things that you enjoyed and kind of where you are right now in your career. So once you're ready, we'll go ahead and get started."

@0:36 - Rabiea:
"All right."

@0:37 - Courtney Fulkerson:
"I'm good to go. Perfect. Okay. Could you share some of your favorite moments from the course that enriched your learning experience?"

@0:44 - Rabiea:
"First of all, thank you very much for having me here and giving me this platform to share my feelings and experiences about this amazing course. So I would just briefly. I'd like to introduce myself to you for it. I'm a physician and also a pharmacologist. Being a physician and a pharmacologist gives me a strong foundation in health care and pharmaceuticals. I just recognize the importance of enhancing my skill sets through knowledge of pharmacovigilance because I believe that it plays an utmost important role in enhancing the public health and specifically the patient's safety. And I believe that it is critically important for the physicians to understand the importance of reporting and monitoring the side effects of the drug. So this was probably one of the main driving forces at why I chose this sport, so I wanted to be a part of it. And secondly, yes, I wanted to pursue my career as a drug safety physician. And I think when I scrolling down to various forces, I found this course has very comprehensive, you know, course with a very, very complete and comprehensive curriculum. You know, I think the best thing about this certification course was that, you know, it slowly and gradually it builds your knowledge starting from the very, very basics of, you know, the key terminology is a pharmacovigilance. Like what is pharmacovigilance and how can one differentiate between an adverse event and an adverse drug reaction. And then, you know, introduces with the concept of signal detection and risk management. And, you know, so it slowly and gradually it builds your knowledge and starting from the very basics. It, it takes you deeper down into the subject."

@4:27 - Courtney Fulkerson:
"Yeah, it seems like it gave you a good foundation and you were able to kind of see where it fits in where you want to go or maybe where you're able to use it right now as well."

@4:38 - Rabiea:
"Yeah, and I would also like to add about the portion on the ARGIS safety database, so I think it's so good that, you know, those videos, they give you a feeling, you know, after going through all those videos it gives you a feeling that you're actually working on it. And you know, I'm so much confident, you know, Although I'm not a part of any industry right now, but I have a feeling that as soon as I get a job and I get to work on that ARGA safety database, I think it will not be something new to me. I'm so familiar with that now. And everything has been explained so nicely and deeply in depth that you feel like a part of it. And it gives you a very good familiarity with this. I think hats off to the program and I'm who it is. It's a wonderful thing."

@5:30 - Courtney Fulkerson:
"Right, that's really good feedback. I feel like just knowing that you would feel comfortable once you get into a time where you'd be able to use it. And that's great for sure. My next question was what sort of program were you looking for when you chose CCRPS and were you pleased with the content? I know you kind of touched on that already, but just maybe an overview of what exactly you were looking for, whenever you decided you were going to start looking for a program."

@5:56 - Rabiea:
"All right, so yes, as I told you earlier that I was actually looking for a program that could enhance my understanding on drug safety and being a physician and a pharmacologist as well. As I said earlier, I think it's the most important thing to be aware of the fact or to understand this critical point that public health and specifically individual patient safety is very important. And the reporting and monitoring the adverse events or the side effects, it's crucial for any physician, I suppose. So it's not just that the program is I think not only for those who want to pursue their careers at drug safety position, but it's also very important for anyone who's in health care health system. Because it starts from very basic and digs down deeper. So I think for anyone who wants to have information to a certain level, I think this program is the best platform to, know, learn all of those experiences through it, yeah."

@7:05 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Good, and then is there anything that you would change or that you feel like could have been enhanced to make it a more rewarding learning experience for you?"

@7:15 - Rabiea: "Yeah, all I think that the program is very comprehensive and all the materials are already there. But, you know, I would just suggest that maybe, you know, if there is some place for interaction, something like an interactive session. Okay. Yeah, you know, something that can also help you in terms of job placements, although there is a portion that covers about the job placement program as well, like what roles one can play after completing this course or something. So, but still I would say that a few more interactive webinars or sessions to solve your queries there and then or to have more fruitful discussions. I think that can add more flavor to the program."

@8:04 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah. And we've actually, I've heard that from a few other people, just having like an interactive element so that you're able to maybe put what you've got into action, I guess."

@8:14 - Rabiea: "Yeah, because you know, when you're actually going through the program, you're reading stuff like that, there are few things, you know, that keep on popping in your mind and you want to discuss them and, you know, at certain points. I think that's one thing."

@8:28 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "That would be useful. Okay. Perfect. And well, any feedback is good feedback. So I'm sure that they would love to take that and just for any future learners or if they ever did like a refresher or something for you, then that would be a good additional element to add in there."

@8:55 - Rabiea: "Actually, I'm also doing a certification program at McMaster University for clinical research. I think the good thing about this program was that I was also able to, you know, merge my knowledge between the two courses. And you know, I think if you also include the safety portions of the study protocols, or like the safety sections of investigators brochure, you know, could discuss more on that, I think that will also help, you know, practical experience when you're actually working in the industry, because there are multiple roles that you have to do when you're actually working. So I think maybe that can be a little more initiative program."

@9:49 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah. Okay. That's great. When you were considering enrolling, was there any specific information on our website that could have better highlighted the benefits of the course?"

@10:00 - Rabiea: "Sorry, I didn't get that."

@10:02 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Whenever you were considering enrolling, was there any specific information on our website that maybe could have better highlighted the benefits of the course?"

@10:12 - Rabiea: "No, I think it was pretty much sufficient. And yeah, it was eye-catching. When I opened the website, there was sufficient information over there."

@10:25 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "I could immediately figure out, yes, this is the thing that I'm actually looking for."

@10:30 - Rabiea: "So it was easy to navigate and just... It's easy to navigate, yes. Okay, good."

Olajumoke transitioned from plant biology to clinical research, boosted by a CCRP course that enhanced her job readiness and career progression in clinical research recruitment.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Olajumoke Owati's feedback underscores the effectiveness of the CCRP certification course in providing a solid foundation in clinical research. Her suggestions for including PDF content highlight an opportunity to enhance the course's accessibility and utility. Her positive experience and subsequent career success exemplify the course's potential to significantly impact professional development in clinical research.

Key Takeaways

● Olajumoke appreciated the comprehensive introduction to clinical research provided by the course. The curriculum covered essential topics such as clinical trials, informed consent, patient safety, adverse event reporting, and ethics, which she found fundamental for beginners.

● The video format of the course was engaging and facilitated easy understanding of complex topics.

● The course significantly boosted her confidence, enabling her to secure a job in clinical research. She felt well-prepared to discuss clinical research topics knowledgeably during job interviews.

● Olajumoke highly recommends the course for individuals starting a career in clinical research, citing its affordability, comprehensive content, and engaging delivery.

Program Structure:

● Learning about subject recruitment was particularly enlightening for her, providing practical knowledge that directly applied to her job in clinical research recruitment.

Learning Tools:

● The course's affordability and comprehensive beginner-level content were decisive factors in her choice. Olajumoke was transitioning from a background in plant biology to healthcare and was drawn to the structured learning path offered by CCRP.

@0:01 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Well, sorry about the technology issues, but I'm glad that I have you here and congrats on successfully completing your CCRPS program. And of course, thank you for taking time to meet with me. We're pretty much just going to go through a quick question and answer style conversation. And then once you're ready, we'll just go ahead and start going through this."

@0:24 - Olajumoke Owati (iPhone): "All right. That's why you're welcome and I'm happy to connect with you too."

@0:29 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Perfect. All right. Could you share some of your favorite moments from the course that enriched your learning experience?"

@0:36 - Olajumoke Owati (iPhone): "Oh, thank you. I learned about fundamental clinical research, clinical trials and responsibilities, informed consent and patient safety, adverse events reporting and responsibilities. I have to learn about ethical research in vulnerable populations, management, data handling, record retention, subject retention, compliance. What's my favorite moment is learning about recruiting subjects in clinical research."

@1:12 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Awesome. What sort of program were you looking for when you decided to choose CCRPS, and were you pleased with the content of the course once you got started in the program?"

@1:22 - Olajumoke Owati (iPhone): "I was looking for a beginner course in clinical research, and I was pleased with the content immediately. Expected, because when I was in my master's of public health, clinical research stood out to me, and I was so happy to learn more about clinical research after reading about the TOS-KIGI experiment, which was unethical then. And I was like, okay, I would like to concentrate in clinical research, then I went online to look at the cost. I can do the certification I can do and I came across the Advanced clinical trial course at CCRP has and I looked at the content and I saw that that was exactly what I was looking for. Yeah, I'm glad that that fit for you and hopefully you enjoyed your experience. I'm looking back."

@2:22 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Is there any aspect of the course that you feel could have been enhanced to make the learning experience even more rewarding?"

@2:29 - Olajumoke Owati (iPhone): "Yeah, all the aspects of the course honestly because it's self-paced is video. You can play back here again. I am just wondering if the video content can be available to us as a PDF document. Because some learners love to read too instead of watching the videos only. This can be available at an additional cost if possible or should be provided after obtaining the certificates. So, maybe after completing the program, if you want to have the PDF for the whole content as the reference material, that can be made up of legal."

@3:12 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Okay, that's good feedback and I'm sure that they will take that back and that would definitely benefit any graduate of the course for sure, just that they would have that reference."

@3:30 - Olajumoke Owati (iPhone): "None then, because I was looking for a beginner course in clinical trial and that all the elements I need as a beginner has been included in the course. So as a beginner, the course is very sufficient."

@3:45 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "That's really good to hear. When you were considering enrolling, was there any specific information on our website that could have better highlighted the benefits of the course?"

@3:56 - Olajumoke Owati (iPhone): "Okay, when I was considering enrolling. Honestly, immediately I did the intro because I know there was an introduction that you can sample the course to see if it fits for you. I was chilled and everything works well for me then and that was why I enrolled."

@4:18 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Okay. That makes sense. I'm glad it fit for you. Would you consider revisiting the course for a refresher?"

@4:27 - Olajumoke Owati (iPhone): "And is there any specific information that you'd want to see within a refresher course? Yes. I always revisit the course when I started my career in clinical research to better understand how to consent participant in clinical research."

@4:44 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Okay. Perfect. And if someone from our program were to ask you for recommendations for future editions such as the 2025 edition coming up, would you be open to sharing a list of recommendations and potentially being featured as a course contributor for that edition?"

@5:00 - Olajumoke Owati (iPhone): "Yes, I will."

@5:01 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Okay. If someone would be in touch about that, I don't know when, but somebody at some point will be in touch with you. Just because recommendations are good and obviously if they use them, then they would want to give you that credit."

@5:17 - Olajumoke Owati (iPhone): "Could you share what factors motivated you to choose this course and how it stood out from other options that you might have considered?"

@5:52 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "And did you explore other offerings whenever you were deciding you'd look to other ones?"

@6:00 - Olajumoke Owati (iPhone): "Yes, yes, I was like three to four. So when I was comparing the prices, the costs rather, the cost was cheaper, was the cheapest. Yeah. the content was all I needed, and very affordable and comprehensive, so."

@6:20 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Okay, perfect. And can you share about your professional journey prior to embarking on this course and how you envisioned the course would contribute to your career growth?"

@6:31 - Olajumoke Owati (iPhone): "Thank you for that question, that's a very comprehensive question. I used to be a plant science biologist back in Nigeria before looking into the United States of America. And I've always wanted a career in human health care profession, and I saw this opportunity as a new beginning because I've always been in plants and I want to transition to human science. So I decided to take some anatomy if you feel like. and medical technology courses at the Montana State University, where I got a certificate in medical assistance. And after graduating from the school, my quest for knowledge and eagerness to contribute to research in human and making impact made me enrolled for a master's program in public health at the Concordia University of Nebraska. even already had master's of science in plant pathology back in Nigeria. So part of the course if I took where Hall was about clinical research, like because Piggy, I stayed here home and I did about statistics, which talk about patients retention, and how to calculate the statistical analysis and clinical research. And I got interested in the field. So before completing my NPH, they're in high-class and looking for a certification course soon. and my knowledge and launched me into the industry and I came across the advanced clinical trial system certification course which enhanced my knowledge and I started applying for jobs in clinical research even before I completed my masters of public health so I already had the certification after I came across that I did the certification within three weeks and I added that to my resume. Fortunately for me I got the job at a legal health research as the patient engagement associate and that is all about clinical research recruitment where I recruit the right subjects for different studies so that was how I started my career in clinical research and the first question I was asked was do you have a study so that I added the certification from your complaint and I was asked to talk"

@9:00 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "for them about it."

@9:01 - Olajumoke Owati (iPhone): "So I was able to tell the interviewer everything about the little child in a realistic way and she was very impressed by my education too. I got the job."

@9:15 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah, that's amazing that it got you to the position that you're in now and it seems like you're liking your career so far. So I'm glad to do that in some way. And you said it took you three weeks to complete the course."

@9:29 - Olajumoke Owati (iPhone): "Yes, yes, it took me to get some intensive study. Yes, the character was so determined to finish the certification on time and started career before I completed my master's of public health so that by the time I completed my master's of public health I will have a job in clinical research then I can grow in my career."

@9:55 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Okay, yeah, that's awesome. And then after master's How did you update your resume to reflect the skills and knowledge that it gave you and how did it enhance your professional profile?"

@10:08 - Olajumoke Owati (iPhone): "Yeah, I included all the information I acquired, coupled with the experience I have in healthcare and the certification enhance my chances of getting a job because interview about my knowledge of the cost. all I did was I have some specifications before Six Sigma quality management, certification, too. I just added the advanced clinical trial, assistant certification, and that was number one because I was looking for a clinical research job, so that was number one and I added skills and also the confidence I learned in the cost."

@10:49 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Good. I'm glad that it made you confident and it definitely made you stand out as a candidate. I'm sure for recruiters and getting that next job. How would you describe your experience with our learning platform and did it facilitate a smooth and engaging learning process?"

@11:06 - Olajumoke Owati (iPhone): "Yeah, the experience is very fantastic because like I said earlier home, it's video and you can always pause playback to know to hear again and assimilate the information. The whole thing I would like them to have is the PDF format because sometimes you may not just be in the mood to listen to videos but I know that the video is very engaging you have to sit down, listen, write and also there were case studies so the learning experience was fantastic for me and it was smooth and the platform too is there were no glitches so that's a smooth layer."

@11:50 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "That's good to know. Can you share how the course boosted your confidence and prepared you for your job interview or career-advancing clinical research?"

@12:00 - Olajumoke Owati (iPhone): "Yeah, so because we said my confidence because like I said, Helia Horne online, it's just like a comprehensive course to bring everything together. So the course I said from introduction to clinical research, clinical trial management, data collection and form consensus, patient recruitment, the history of clinical research. So I was able to see everything as a story, like it's storytelling. So I was confident when I started interviewing, I was being asked some questions and there were case studies during the course. So I could apply the case studies and also the ones I learned during my masters of public health. So I think that was what got to my interviewer."

@12:56 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah."

@12:58 - Olajumoke Owati (iPhone): "Yeah."

@13:00 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Good. And what part did you find most engaging and beneficial to your professional development?"

@13:05 - Olajumoke Owati (iPhone): "And the part I love most is the clinical research recruitment because I said, okay, so it is not just HR, EMR resources and recruits. recruiting, I was kind of confused in the first place that how we hire them both. After doing the course, I realized that, no, we are not hiring them, but we are recruiting volunteers. so that was what stood out to me because I was initially confused that way. Fine, we are paying them, we are not paying them for what they do, we are just competing, fitting them for their time and their willingness to add to research. So that was what stood out to me and also I was like, okay, if I am into recruiting, I will be engaging with people, talking to different type of people. I love."

@14:00 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "So that was what it's And then that's what you are okay now so that it worked out perfect. What are some reasons that you would recommend this course to others based on your experience?"

@14:12 - Olajumoke Owati (iPhone): "I'm going to recommend this course to others if you want to start your career in clinical research this is a very good course for you number one it's affordable number two it's self-explanatory and it's engaging so and it has everything you need to part your career in clinical research and the course has really helped me and I can make reference to the course if I was to remember one or two things I can always go back to the course and course it's accessible for a lifetime so it's a good investment yeah I think that that part is important just if you ever need to go back it's there for you."

@15:01 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "And last question, can you share how your career has advanced since you completed the course?"

@15:06 - Olajumoke Owati (iPhone): "Yeah. Thank you. started as a patient engagement, how to sit at, illegal health research, and over time I started, and this is 24, started in I still work there, but I have another opportunity here at San Maron CPC, so the illegal health research was a remote position, I still work at the PRR now, so because I changed my place of work, I got another place, which is San Maron CPC that is an onsite position, because after completing the course I started a remote position, but I wanted to come onsite to see those like source documents, screening laws, engage with participants, do the trial additional now informed consent, not just the calling participants. I engage now in telehealth. I do other things in recruitment and it advanced my career. I came on site. started as an outpatient service coordinator where I do the administrative part of recruitment and house. The clinical aspect like taking vital signs, doing EKGs, accusing, and now I am implemented as a clinical recruitment administrative coordinator whereby I package all the advertising materials for higher distribution, which I think it's a big one because before any studies that I already have the information, I package the advertising material by our distribution after that. I design the posters, the flyers, the key to practice the plan and also I do the clinical aspect so it's like a promotion within two years my career has advanced under which is a good one."

@17:13 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah that's amazing and best of luck to you in your promotion and I know you'll be perfect for the job and it seems like you're really passionate about the whole research so I think that they'll be lucky to have you there for sure. That's the end of our interview and I thank you for your time and just sharing your experience with our platform and your input will definitely be beneficial to future learners that are going to take this course so I really appreciate you and like I said I wish you the best of luck you'll get an email from me or from it's from giftagram is where you'll send your gift card here in a bit but that completes our interview."

@17:57 - Olajumoke Owati (iPhone): "Thank you so much."

@17:59 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "All right. Have a great rest of your day. And you too. Bye. Bye-bye. Yeah."

Vinil Transitioned From Overseas PV Roles To North American Market Success After Gaining Crucial Regulatory Knowledge Through The CCRP Course.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Vinil's feedback highlights the CCRP certification program's effectiveness in providing comprehensive education in pharmacovigilance and clinical research, tailored to the needs of professionals transitioning to the North American healthcare sector. His successful application of course learnings in securing employment underscores the practical value of the program. Vinil's suggestions for including more regulatory comparison could help further tailor the course for international professionals.

Key Takeaways

● Vinil appreciated the broad understanding of pharmacovigilance (PV) and clinical research that the course provided. It helped him connect his previous truncated job roles into a coherent whole.

● The course content was instrumental in helping Vinil transition to the North American job market, particularly with knowledge about PV processes in North America.

● The course content directly contributed to Vinil securing his current role, allowing him to effectively discuss industry standards and processes during job interviews.

● Vinil valued the self-paced, online format of the course, which was crucial for managing his schedule as a newcomer to Canada.

● Vinil would recommend the course to others, especially those new to North America or transitioning roles, due to the course’s comprehensive content and flexible format.

Favorite Course Elements:

● Learning the end-to-end PV process was particularly enlightening for Vinil. He enjoyed how the course detailed each step of the process, which enhanced his understanding of his role in the broader industry context.

Content Satisfaction:

● The course met Vinil’s needs perfectly by providing detailed guidelines and regulations for FDA and Health Canada submissions, which were crucial for his career transition in North America.

Website and Support:

● The website was user-friendly and informative. Vinil utilized the chat feature to get immediate answers to his questions, enhancing his enrollment experience.

@0:00 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Meeting is being recorded. Once again, thank you for meeting with me today, and it's a delight to have you here. Congrats on completing the CCRPS program, and I'm pretty much just going to go through question and answer a soft conversation, just to hear your feedback and your experience with the program. So, once you're ready, get into it."

@0:20 - Vinil: "Yeah, sure."

@0:22 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Perfect. Could you share some of your favorite moments from the course that enrich your learning experience?"

@0:28 - Vinil: "Yeah. So, I did work at a PV level, you know, at my previous organization, but then it was always truncated. The information given to us was always limited to the job at hand. So, I was initially in triage. I was a researcher first, and then I was in triage, and then I was in with the ICSRs and individual case safety processing. But the course really helped broaden my view on all that was going on. Yeah, I got to find out what happens, you know, after a case is processed, you know, how it helps in signal detection and how it, you know, participates in generating a signal and the safety limits and how it goes on into the PSERs and PADERs. Because this information was always, you know, it was always on the need to know basis, you know, when you work within a team, when you work with other doctors and whatever it's always also this happens there and this goes on this way. But then with the course, everything was so structured. So I got to see, you know, where my role comes in as a PV professional, as somebody dealing with whatever adverse event and it gave me a very nice perspective start to finish on what happens. I was very thrilled with that."

@1:42 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah, good. So it gave you a more, I guess, broad and full circle of how everything is working together. That's good to hear. What sort of program were you looking for when you chose CCRPS and were you pleased with the content of the course once you got started?"

@2:00 - Vinil: "So, the CCRPS was exactly what I was looking for because I moved countries recently, and previously I was back home in my home country of India, where things work a little differently over there. When I first came, I moved to Canada two years ago. I wanted to have an idea of how the North American markets work, what they look like, what they expect from an interviewee. So, the program with the CCRPS really gave me an idea, especially with regards to submission guidelines, what submission timelines are with regards to Health Canada, it is with regards to the FDA, so this is exactly what I was looking for. I was looking to find my footing in sort of the PV scope in this part of the world, and it was exactly what I wanted. It gave me a very nice understanding of how things are done, and I was very informed once the course was done."

@2:58 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah, that's a really good thing. Is there any aspect of the course that you feel could have enhanced the learning experience to be more rewarding?"

@3:07 - Vinil: "I don't know if I can honestly answer that question because, again, coming from a research background, I had an idea of most of the things, but then I never knew where it fit on the grand scale of things. Because, again, when you work with a corporation, your role is always truncated, and your role is always directed towards what you're doing, whatever task is assigned on your hand, that's what you focus on. So the course really opened things up, so I don't know if there's anything more that I would have wanted from the course itself."

@3:41 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "I don't know if that's the answer you're looking for. No, I think anything that you're Yeah, because I got a very broad perspective on, so because there were lot of case studies as well."

@3:52 - Vinil: "Remember, towards the end, know, they had case studies, it was very informative, so I don't know what I would want more. Yeah, I don't think I can answer that question up because I don't allow out of it. So I don't know about my question too. And so that maybe in a few years to come, I should be able to answer that."

@4:09 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah, well, good. I feel like even if, I mean, if you were saying that you had everything that you needed, then I feel like that's still good feedback. Absolutely. Or if they're looking to add anything, maybe it's already where it should be. So, always good. Were there any additional topics or elements that you wish were included that could have further elevated your understanding?"

@4:33 - Vinil: "So, the course was very, you know, very uniquely structured and that it started with the history of pharmacovigilance and it went into what kind of jobs we can look at and what roles are and, you know, and what are the median lines for what we ought to do. So it was very well structured that way. I think, and again, I wasn't professional. I just that I wasn't aware of how it occurred, just part of the world. I guess. maybe some sort of some sort of a bridging program where they helped you know just especially from participants who are coming from different countries because we we have different supervision guidelines in different countries like so if it could maybe bridge the gap between what we I know it's kind of a you know broad range just to zoom okay these are the kind of students we're going to have but if something if it could bridge between you know the FDA and and have Canada and whatever we did you know probably make the process a lot more I guess streamline in that sense as in so I would know okay with regards to the Indian submission this is what I did and this is what you know I have to do with regards to the FDA submission these are the reporting timelines these are the reporting failures so maybe that alone I guess okay so more of like a global um yeah you know because I mean at least from most of the reviews when I read I mean a lot of them were were agents who had previously worked in you know out of APOC So it definitely will suit, you know, once you target it towards a global audience, I think it definitely would help, yeah."

@6:09 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Okay, perfect. And when you were considering enrolling, was there any specific information on the website that could have better highlighted the benefits of the course?"

@6:21 - Vinil: "No, I think, I mean, I just read a lot of the testimonials, I read a lot of the And yeah, I was really happy because I was looking at a few other programs. was looking at a few universities where they did the exact, you know, I mean, that's what they said that they would do. And no, I got, I got all the information from the website. And I was able to speak to somebody, you know, on the, on the chat. And I was, I got a few questions. wanted to know how they would go about doing this. And yeah, I was, I had all my, all my questions answered. So no, I found the website very, very convenient to use and very informative. I was able to make a decision. And I think, I think the Third day after I looked up on the website, I joined."

@7:03 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "was like, okay, no, I'm game. Yeah, that's great. Would you consider revisiting the course for a refresher? And is there anything that you would want to see within a refresher course?"

@7:16 - Vinil: "Yeah, that is interesting. Yes, I would consider revisiting the course. I already have some of the PDFs was originally offered as well, but especially with regards to progressing and moving forward, moving from just your individual case, if you're processing to moving towards different roles to help with working and offering payders or PSURs, if anything is available on that sort, yeah, would definitely want to revisit the course again, if I can get a little more information on that. Because what I did as well, you know, when I was interviewing and once I was done with CCRPS, This is what I said on my interviews is that, you know, though I have not been technically trained on these things, I'm aware of these things because of the second program I got to CCIP, yes. I did mention it on every interview. So and I'm also, I think my last interview, the hiring manager said, okay, I'm glad that you know these things. So it's going to be easier when you hit the ground running."

@8:21 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "So in that sense, yeah. Good, good. I feel like it did give you a good broad, I guess understanding of everything. then you'll be able to apply that to wherever. Okay, if someone from our program were to ask you for recommendations for future editions, such as the 2025 one that is upcoming, would you be open to sharing a list of recommendations?"

@8:48 - Vinil: "Yes, yeah, absolutely."

@8:51 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Okay, someone would be in touch about that. And then that would, if they were to use it, then you would be considered like a contributor to that edition set. It's not as sure comfortable with that, perfect. Could you share what factors motivated you to choose this course and how it set out from other options that you might have considered?"

@9:10 - Vinil: "Yeah, sure. So the first thing, I think, as opposed to any other regular university, like a physical address, I was very glad that CZF was available for me to do online, offline, not to demanding because I was, like I said, I was a newcomer, so I was between jobs and between interviews and just handling things on the domestic level, and I was a newcomer to the country as well, right? So, so many things. I was just happy that the program was accessible, I got all the source material, I got the individual quizzes that I had to do, I was given a deadline for that, and I had enough time to prepare to study up and to, you know, to make myself sure that, okay, these are the things that I know. This is what I'm going to do. It was very accessible that way. So for somebody who is busy and for somebody who wants to upscale and he was busy working and wants to learn more, this is the perfect course because when I looked at many other universities, local colleges as well, it was too much of an ordeal. Like it was okay, you have to be seven hours, you have to be here, you have to go talk to this person and do that. So the fact that it made everything approachable was definitely a huge feather and it was a huge benefit. that the structure was very, very reasonable as opposed to a lot of the local colleges, even university, local colleges over here. That was another thing that I was very grateful for. just charged it to my card and did like I think a four-month installment."

@10:51 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "was really happy. Yeah."

@10:52 - Vinil: "It just meets all the criteria."

@10:54 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "it's all of your boxes and that's perfect. That's perfect. Could you share about your professional journey prior to embarking on the course and how you envisioned the course would contribute to your career prep?"

@11:08 - Vinil: "Yeah, so like I said before, I was completely unaware from a North American, from how PV was being directed and how it was working. So I'm so glad that once I was done with the course, I was able to apply for, because the course also towards the end starts giving you ideas and what kind of roles you can apply for and what kind of qualifications you need and gives you an idea of how to use those words. So I did use lot of those words, I did use a lot of those terminologies. And so when I was just applying, it was not just willing, I was not just applying to anything I could find. I was looking for specific roles, coordinator roles or roles that involved analyzing and processing information. So that was very beneficial that I got out of the information that was given towards the end of the course. So that was a big help and what. What it also gave me was so when when I was interviewing with a lot of the managers when I this is what I said the verbatim Well, I have not worked You know with regards to health Canada submissions or the FDA submissions. This is what I gather. These are the this is the information that I've gathered This is what I know of what happens Yeah, these are the kind of these are your submission protocols These are these are the submission timelines and I've gathered this because of the course that I did so It worked, you know on a two-prong level in the fact that I knew these things and In the in the interim, you know, as I said mood or whatever. I was not just sitting, you know sitting idly I was doing certification So that really helped and I got called back by the same manager for two different interviews because of that Okay, yeah about 30 people who interviewed but because of that I was called back for the second time I don't you know, my the hiring manager remember me and said I remember you You know, you mentioned on the first interview and then can you speak more to that now? I did. And yeah, that's the job that I'm working on right now."

@13:03 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "So that's really good to hear."

@13:05 - Vinil: "Yeah, absolutely."

@13:06 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah, you were able to apply it and it got you the job, it sounds like."

@13:10 - Vinil: "So that's that's awesome. Yeah, it was a wait, but, you know, for the same manager to have called me back like two months later and to interview me again was, you know, something had to stand out. And the fact that I said, you know, as much as I'm a newcomer and I've never worked, you know, this front, this is my knowledge of of such and certain that I got this from the court and certification that I did."

@13:32 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "So yeah, weapons using. Yeah. About how long did it take you to complete the course to absorb the knowledge? And then do you feel like the duration was adequate for your learning?"

@13:45 - Vinil: "Yeah, that's a good question. So because I am from, you know, research in a PV background, I had, you know, idea of most of the things. So I think I spend a total of, I guess, 10 days, okay, just me studying and going through it. I mean, if you're really going to be taking your time, it should probably be two to three weeks or maybe a month, because I already had a working idea of most of these things. I was able to, you know, accelerate and go through the course material. And because, you know, I have this, I knew what the CTCA was, and I knew what the scoring was like. So I was able to move through quite quickly. I mean, I took about 10 days and that was, and again, like I said, I was managing, I was bouncing between two jobs and taking care of things on a messy front. 10 days was, was, was very comfortable for me to work with. So yeah, I definitely said, so if somebody is from, from a COVID as a background, or from a clinical research background, maybe two weeks is that is a good enough time to go through the material and to get as much as you can out of it."

@14:46 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Right. And the fact that it's self-paced, I feel like helps to just figure schedule and you're able to use as much time as you want to there."

@14:54 - Vinil: "So that's, yeah, absolutely."

@14:57 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "All right. After completing the course, how did do you update your resume to reflect your newfound skills and knowledge and how has it enhanced your professional profile?"

@15:07 - Vinil: "Well, first and foremost, I made everyone know that the identification was completed. I put it up on LinkedIn and that was one of the first things that I did to show them that, you know, within the time that I had these are the these are some of the things that I did. And I also started altering my resume and my CV to let them know that, you know, besides whatever responsibilities and duties that I had, my my general knowledge of certain such things, you know, again, like I said, you know, the submissions or whatever was was up to date because of the, you know, certification that I did, I had hands on access to most of the databases, the safety databases back home. But that was, you know, the chink in my armor, the fact that I was not aware of certain things. So on the horizon, I've mentioned, you know, after the certifications that this is the general, you know, knowledge of things that I've gathered over the period of time, and that I had. which was because of course so that's how I put it on my resume and even on my telephonic interviews and my live interviews that's what I said."

@16:08 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah that's awesome I feel like you really you've had a good experience at that for sure."

@16:12 - Vinil: "Yeah and it also helped because I'm technically not in a health care professional you know I'm not I'm not from a head CP background I'm from a research background so I've been one of my interviews when you know I was asked point you know point blank do you think you can serve you know because you're not from a health care professional background but you think you can serve at this level and these are some of the answers that I give that you know it's because of x y and z and then because of my knowledge of this this and this is that I'm confident that I'll be able to serve so I was able to say all of that because of what I've gathered and what I gleaned."

@16:44 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "that's amazing it definitely helped with your transition into the field."

@16:49 - Vinil: "Yeah how would you describe your experience with our learning platform and did it facilitate a smooth and engaging learning process? Absolutely the platform is so was very easy was very easy to navigate and to go through it was not with the UI was amazing and you know the PDF forms it was it was downloadable so I could read so sometimes what I do is I download a few of the PDFs and I would take it on my phone and if I had long bus journeys I would just sit on the bus and just go through some material like driving up to an interview or back so it was very I should say it was very open it was very user friendly and the point of the course was not to stun inflammation or to keep it protected or just cover it up which unfortunately most of you know when you work at major organizations it's everything in document controlled and it's only on a need to know basis so this was very in that sense so yeah it was very very accessible accessible is is the accessible and user friendly that would bring up yeah awesome I know you kind of touched on this but can you share how the course boosted your confidence

prepared you for job interviews and career advancements in clinical research? Yeah, so I mean, I felt like I got new shoes on, you know, once the course was done.

Okay, I found my footing. This is exactly, you know, this is to bridge the gap between my overseas experience from back home and what I can offer any company that would hire me.

So at this point, I'm working with a patient support service system. So because of my understanding of, okay, these are the regulations and the guidelines for FDA or Canada, I was able to do really well on my interview, you know, with our prior experience in this country, I was able to go and convince my interview managers and the powers that be that I'm a good fit for them.

And yeah, I think it's going to be a year with this company. And I think I got the job.

Let's see, I was done this is your piece in the month of September or October. and it was about four months after that.

yeah, it's been a great 14 years."

@19:04 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah, yeah, that's amazing. I feel like it really did. It helped you. It definitely boosted your confidence. And I feel like you were well prepared for your next role for sure."

@19:15 - Vinil: "Yeah, yes, I was."

@19:16 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "What part of the course did you find most engaging and beneficial to your professional development?"

@19:23 - Vinil: "Well, with regards to upskilling, you know, you know, just just the amount of information with with the painters and PSURs and how the safety information that is being collated and collected by different teams, how that goes into just the overall, the life cycle and history of a drug, know, mean, post marketing surveillance, that was the big picture for me. And hopefully I want to get into that role as well, because I've done my due diligence and I've done my put in the hours with everything else, know, started with three hours and everything else. And so now I feel like because I'm a of that, you know, more than just the terminology or what I'm aware of what goes on there. So I'm hoping that I can upskill myself, you know, and start contributing to the overall life cycle of, you know, the safety profile of the drug, now volunteering and by working at those levels. yeah, that's something that I got very clearly from the program. It was not just hearsay or listen a few medics talk about, okay, or that, you know, whenever you're going to submit that. So it was very interesting in that way. So now that I know what kind of role it is and what it entails, and I know what more is needed from me, I feel like I have a better chance of getting it at this point."

@20:42 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah, for sure. feel like it gave you just some interest in something that you maybe didn't know before. Okay, last question that I have for you. What are some reasons that you would recommend this course to others based on your experience?"

@20:57 - Vinil: "Well, because it made my interview process. is a lot more interesting in that I didn't have in that I now had a lot more resource material with me. So I think I would recommend this especially for newcomers who come from Asia-Pacific background and you know when we're not aware of certain nomenclature and certain guidelines that are swallowed and this part of the world. I would recommend that to anyone and everyone who comes there. Even if you do have a pharmacologist's background or research background or whatever it is you in clinical set I would definitely recommend this program just to make sure that you have enough in your quiver so that you can really do well on your interviews and it brings you up to speed when you start fresh as well."

@21:45 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah okay well that was great I feel like you had a great experience with the program and I can definitely tell just that it's helped you get where you are now and I feel like you had a great success story with it. So I really appreciate your time that you took to spend with me. today and just go through some of those questions. And I know your input and just your experience will definitely have an effect on future learners that are in the program. So I really appreciate you. And I wish you the best of luck in your career. I feel like you have a great understanding of clinical research and it's definitely going to be, you'll have a great career from here on out."

@22:21 - Vinil: "Thank you so much for being here."

@22:22 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "All right, thank you for the program as well, yeah. Yeah, well, I will send you an email. You'll get an email by saying with a gift card for doing this and spending time with me. But for that, we are pretty much all set. So I really appreciate you and I hope you have a great day. Thank you, you too. All right, thank you, bye bye."

Rose Hyson Transitioned From Educational Research to Clinical Trials Project Management, Enhancing Study Compliance and Management Skills Through the CCRP Course.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Rose Hyson's feedback underscoring the CCRP certification program's effectiveness in delivering comprehensive, flexible, and applicable education in clinical research management. Her experience highlights the program's utility in real-world applications, such as preparing for audits and enhancing trial management. Suggestions for more interactive content and additional focus areas suggest avenues for further enrichment of the course to cater to a broader range of professionals within the clinical research field.

Key Takeaways

● Rose found the PowerPoint slides provided during the course exceptionally useful for reference, especially useful when revisiting content for practical application.

● The section on master trial files was particularly valuable for Rose. She applied this knowledge during an audit she faced shortly after completing the course, significantly aiding in her preparedness and response.

● While Rose appreciated the self-paced nature of the course due to its flexibility, she noted the experience felt isolating at times. She suggested that incorporating more interactive videos could enhance engagement and diminish the sense of isolation.

● The content on trial processes and paperwork was highly relevant and applicable across various trial types, proving beneficial in her role.

● Rose would recommend the course to individuals transitioning into clinical research manager roles due to the foundational knowledge it provides.

Content Satisfaction:

● Coming from a non-clinical trial background, Rose valued the comprehensive introduction to clinical trials, which helped bridge her knowledge gap as a new clinical trials project manager.

Learning Platform:

● Rose found the platform easy to use and appreciated the availability of materials for download, which facilitated her learning during commutes.

@0:00 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
This meeting is being recorded. Right, well, it's a pleasure to have you here, and congrats on completing the CCRPS program. Thank you for taking the time to meet with me.

@0:11 - Rose Hyson (Hennepin Healthcare):
We're pretty much just gonna go through a question and answer style conversation, and just get your input and your experience with the program, and then once you're ready, we'll go ahead and get started.

@0:22 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
All right. Could you share some of your favorite moments from the course that enriched your learning experience?

@0:32 - Rose Hyson (Hennepin Healthcare):
So I think a lot of the PowerPoints ended up being really useful, and I've gone back and looked at them over and over again. Initially, during the learning process, it might not have seemed like a highlight, but in the end, they've been very beneficial to me.

@0:56 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
Okay, good. It’s always good to know that you can go back and look at the materials when needed. What sort of program were you looking for when you chose CCRPS, and were you pleased with the content of the course once you got started?

@1:13 - Rose Hyson (Hennepin Healthcare):
I'm a clinical trials project manager and came from an educational background, so I had a lot to learn specifically about clinical trials. There was some repetition from other HIPAA and city training, but the section about the master trial files was most crucial for me. It was the most important part for me, especially since I was audited right after I took this course. It was very beneficial as I could immediately apply what I learned.

@1:57 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
Master trial files?

@1:59 - Rose Hyson (Hennepin Healthcare):
Yes, that really was the most important part for me. There was a lot of new learning there, and I was able to apply it directly during an audit, which was extremely helpful.

@3:05 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
That’s great to hear, especially that you could use the information right away. Looking back, is there any aspect of the course that you feel could have been enhanced to make the learning experience more rewarding?

@3:38 - Rose Hyson (Hennepin Healthcare):
For me, having the course be self-paced was important but it also felt a bit isolating at times. I was never sure if there were other people behind the program.

@4:08 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
Okay, that’s valuable feedback. Were there any additional topics or elements you wish were included that could have elevated your understanding of clinical research?

@4:31 - Rose Hyson (Hennepin Healthcare):
Since all of our clinical trials are behavioral rather than pharmaceutical, including a bit on behavioral trials would be nice, even though I know that’s a rare group compared to other clinical project managers.

@6:00 - Rose Hyson (Hennepin Healthcare):
This course was more approachable and affordable than others I considered. It was important that it was flexible and could be done on my own time.

@7:05 - Rose Hyson (Hennepin Healthcare):
I jumped right into being a clinical trials project manager without much prior experience. This course helped me bridge the knowledge gap I had in clinical trial management, which was incredibly beneficial.

@8:38 - Rose Hyson (Hennepin Healthcare):
That's a good idea. I haven't updated my resume yet to reflect the skills and knowledge I've gained from this course.

@11:00 - Rose Hyson (Hennepin Healthcare):
The most engaging and beneficial part of the course for me was about what you should have in terms of paperwork, which is true for both behavioral trials and other types of trials.

@12:38 - Rose Hyson (Hennepin Healthcare):
The course allowed me to manage our studies more effectively. They are now going strong and are compliant, so I won't need to be nervous if audited again.

Ossai Opene: From Process Safety Expert to Clinical Research Novice, Gaining Confidence and Direction with CCRPS Certification

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Ossai Opene’s feedback highlights the effectiveness of the CCRPS certification program in providing a comprehensive educational experience tailored to individuals transitioning into clinical research. His suggestions for course improvement focus on optimizing content organization and exam processes to enhance educational outcomes for all participants. His positive experience reflects the program’s capacity to equip newcomers with the confidence and knowledge required for a successful career in clinical research.

Key Takeaways

● Ossai appreciated the straightforward, easy-to-follow video presentations and found the sample questions at the end of each module particularly useful for reinforcing learning.

● He suggested that restructuring the course to group related topics together, such as inspections and audits, would improve logical flow and learning efficiency.

● Ossai recommended generating new, random questions for each exam attempt to ensure a robust testing experience, enhancing the learning outcome.

● He found the roles and connections between CROs and CPIs most engaging and informative, providing clear insights into the clinical research operation landscape.

● Ossai would recommend the course based on the quality of materials, self-paced format, and positive testimonials from other learners.

● Although new to the field, the course significantly boosted Ossai’s confidence and knowledge, preparing him for potential roles in clinical research.

Course Completion Time:

● Ossai completed the course in one week, leveraging his prior experience in process safety and auditing, which allowed him to progress quickly through familiar content.

Learning Platform Experience:

● He praised the platform for its smooth functionality and engaging format, which included helpful downloads and knowledge checks.

@0:19 - Courtney Fulkerson (CCRPS): "All right. Could you share some of your favorite moments from the course that enrich your learning experience?"

@0:25 - Ossai Opene: "Oh, well, I was thinking in terms of the presentation, the videos were quite very helpful. They were straight to the points and quite easy to follow. I did take some notes, but yeah, they were quite easy to follow. Then at the end of each model, those I had like some sample questions to go through. That's a test. said acquisition of knowledge."

@0:59 - Ossai Opene: "They also. Yeah. they have to just stimulate someone to go back and advance what I've learned or just move forward."

@1:33 - Ossai Opene: "Yeah, it took a while though. I mean, I was just searching how to get into the clinical research space because I'm looking for something I could maybe work remotely as it gets me be. And then CCRPS came to mind. So, I'm looking around pretty nice to my personality and what I want to achieve. And then each time I research, you know, your organization pops up at the top."

@2:42 - Courtney Fulkerson (CCRPS): "Yeah, and you liked everything that was within the content of the course?"

@2:47 - Ossai Opene: "Yes, everything. there are some that but were pretty easy to kind of go through because of my background. Before now, I'm taking a class in design and implementation of clinical trials from John Hopkins University. That was also pretty helpful when I saw that module in the past year of course. I said, okay, that's fine."

@3:14 - Ossai Opene: "So then when it comes to inspections and audits, I'm already familiar with the, I would say with ingredients, but the application of the clinical research is different, but the same methodology. it was easy to also fall out as well. So overall, it was a good experience for me to go through the program."

@6:14 - Ossai Opene: "Hi, no, it was pretty robust."

@7:05 - Ossai Opene: "Oh, I can't think of any, because I did have conversations with your folks online, and so it's planning to lose about three to four months, and that helped me to make up my mind to take the class with you, with your organization."

@8:00 - Ossai Opene: "Ah, I would definitely go to those programs again because I'm not, I'm not actively seeking for a job right now, but yes, I like to go through the programs again, but the bot here is I'm not sure how you structure, um, uh, again, from my background."

@20:17 - Ossai Opene: "Oh, I was everything. Then I would say more in the meat. The meat is the rule of the CRO, CRO, CPIs and how they eat and connect."

@21:00 - Ossai Opene: "Experience. I will say quality of delivery, quality of the materials. will say the fact that is is online and you take that your own pace so some folks are busy walking so they don't have any time in world to sit down in classroom and go through this."

@22:22 - Courtney Fulkerson (CCRPS): "Good. And I feel like your confidence just in the area has definitely grown and hopefully it will take you into your next position."

Clinical Research Coordinator Certification Case Study Featuring February 2024 Cohort Graduate Lisa-Pierre

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share our second graduate case study interview from Lisa, a recent graduate of our CRC certification program.

Key Takeaways

● Lisa-Pierre had a very positive experience with the self-paced online format of the course. She appreciated the flexibility it provided.

● The course gave Lisa-Pierre the clinical research knowledge and confidence she needed to obtain a CRC job right after finishing school.

● Lisa-Pierre felt the course covered all the necessary basics and she did not have any suggestions for additional topics to include.

● The course certificate helped Lisa-Pierre update her resume and get hired at a prestigious research institution.

Impact on Confidence and Employability

● The course certificate boosted Lisa-Pierre’s confidence in applying for CRC jobs despite having no direct US research experience. She believes the certificate was critical in helping her get hired at a top research institution right after finishing school.

Most Valuable Topics

● Lisa-Pierre found the overview of clinical research processes and role of CRCs most valuable. The regulatory topics were important but more difficult.

Recommendations for Others

● Lisa-Pierre would recommend the course to help people get the research knowledge needed for their resume and transition into the field, especially those without research degrees.

Career Advancement

● Completing the course allowed Lisa-Pierre to begin her career as a CRC at Columbia University. She has received other job offers since then.

@0:05 - Courtney: Okay, well thank you for your time and congratulations on you successfully completing the CCRRPS program and taking this time to meet with me and we're pretty much just going to go through a quick question answer conversation pretty much just to prepare the company or future graduates of the program.Okay so can you share some of your favorite moments from the course that enriched your learning experience?

@0:38 - Lisa-Pierre: I think for me what I really liked is that it was self-paced so I started this course I was still in school and I knew that I wanted to get a job like as soon as I finished so I was able to like take my time and then it was tailored to me. I was able to do it at my own pace and go back to the lesson when I was I was unsure about something so that had to get a like what I like the most about the course.

@1:02 - Courtney: Okay, good to hear. What sort of program were you looking for when you chose CCRPS and were you placed at the content once you got started?

@1:11 - Lisa-Pierre: Yes, I was just looking for something to give me more insight on the clinical research coordinater. And I knew little bit about research, but I didn't know about that specific positioning detail. So that gave me a good run-through of what it was about, what I needed to know. And I think I was pretty satisfied with everything I got from the course.

@1:32 - Courtney: Okay, good stuff. Looking back, is there any aspect of the course that you feel like have been enhanced to make it more rewarding?

@1:43 - Lisa-Pierre: Honestly, not really. I feel like I really enjoyed my experience. And I feel like I was able to get assistance when I needed it. I had questions, help. And again, just go back to my lessons.Whenever I wasn't sure about something, so I don't think there's anything I would change from there.

@2:00 - Courtney: of course. Okay. And were there any additional topics or elements that you wish were included within? Basically, just to give you a better understanding of clinical research.

@2:11 - Lisa-Pierre: So I don't think so. I think I covered a lot. Again, I had like a little background on research from school and it went into detail with like regarding other topics that I didn't know about. And now being, I'm currently working as a clinical research coordinator and I feel like I got all the basics I needed. Even when I started the job with the trainings, most of the things that I was being taught in the trainings for the job, not the specific research were doing, I had already seen from the course. So yeah.

@2:42 - Courtney: Well, that's good to hear. When you were considering enrolling, were there any specific information on our website that could have been better highlighted with the benefits of this course for you?

@2:54 - Lisa-Pierre: Um, honestly, it's been a while since I enrolled, but, um, I think for me, like, when I went to look at the course, I just wanted to see, you know, what was included and what I would get from it. And honestly, from what I can remember, I feel like it gave me, like, a pretty detailed information of what it was about and that's what I was looking for. So yeah.

@3:22 - Courtney: Would you consider revisiting the course for a refresher and is there anything specific you'd want to see within a refresher course?

@3:31 - Lisa-Pierre: Yeah. I would definitely go back to it when I first got hired. wasn't scared because it was my first time doing the whole CRC. And I did go back to just have the, like, just have a refresher and just be, be well prepared for my, for my job. I think for me, like, it's a lot about like GCP, I feel like that's something that's really emphasizing. So I'm working in the field, so I...It would be what I would go back to. Yeah, thank you for that input.
@4:52 - Courtney: And then could you share what factors motivated you to choose this course and how it stood out from other options that you may have considered?

@4:59 - Lisa-Pierre: Um, yeah. Oh, I, again, I was in school and I knew that I wanted to work in research, but I didn't exactly like, you know, work in research. When I went on your website, there was a CRC position and that's the one that spoke the most to me because it was, I had it but to me to have like patient facing experience, which is what I was looking for. And again, what mostly attracted me was the self-paced because I didn't want to be subjected to something where I would have to attend classes at a specific time and just be there because I had a lot going on at the time. So that's definitely something that was attractive, like that attracted me to the course. And the other thing is that financially, I think it was a good, it was a good option for like the price and what I was getting compared to others because when I looked at others, a lot of them were more expensive. Well, according to my format, when I compared it to my budget. Yeah. Yeah, that's definitely okay.

@6:02 - Courtney : So you did explore other offers or different programs before. Yes. Mm-hmm then can you share about your professional journey prior to embarking on a course?

@6:13 - Lisa-Pierre: Yeah, so I was in school in Cuba I was a medical student and I wanted to come here to practice. But I knew that like you don't have to pass my exams and I didn't want to have a gap on my CV So I wanted to get into research, but I didn't know how exactly to get into research I didn't want to be doing like just lab work research or just I wanted to have something that was patient-facing why would it gets me to write people and I Think that's that's what led me to deciding to do look into like seriously positions And then I think also when I went on the website like there was a lot of information of what I could do with Um, the certificates, I was like, okay, this seems like something that, um, that's beneficial to me. Um, my prior research experience, it was from full when we had to do papers and everything. So it, I did have experience, but I didn't have any experience here in the state. So. Perfect.

@7:44 - Courtney: Okay. And then after completing the course, how did you update your resume to reflect your new found skills and knowledge and how has it enhanced your professional profile?

@7:53 - Lisa-Pierre: Um, so I just added this, like the certificate on my, um, resume. A lot of jobs I've tried to ask if I had any knowledge of like GCP and they had some other like they had specific things that they asked if I had knowledge on in research and that definitely helped me because I had proof that you know I did a certificate that helped me get the knowledge that I needed for the job. So I feel like that definitely helped me because street out of school with no research experience. think it would have been a bit harder to get a job.

@8:53 - Courtney: Yeah, good. So how would you describe your experience with our learnings?

@9:00 - Lisa-Pierre: Did it facilitate a smooth and engaging learning process? Yeah, it definitely did. I think for me, just had to, hard part was just being consistent because I didn't have anybody to answer to anybody to push me. But I think the learning experience is very nice. It's very detailed. You get, you get all information you need and you get to replay if you didn't understand something. So it's, I think it works because it's, it's, when I compare it to let's say taking classes where you take the clock and that's done, but then you can take the path over and over and over and so you know, you feel like you understand it. And I think that's another thing that I really liked about the program.

@9:45 - Courtney: Yeah, that's a great feedback. Alright, and then can you share how the course boosted your confidence and prepared you for job interviews or career advancements in clinical research?

@9:55 - Lisa-Pierre: Oh, yes. So before I had the sophistication, I knew I wanted to get into research because that would help me on the long haul, but I was scared. I didn't think I was going to find a job because I was a foreign graduate. I didn't have any experience here. I didn't have like the research experience I had was in here and it would be hard, you know, demonstrate like with the guidelines here. It's not the same thing. So I think once I got a tradition, I felt more confident in applying for jobs and saying listen, I had have a certificate. Some of these classes, I know what this is about, I know what research is about, and so I think it definitely boosted my confidence in like just applying for jobs because sometimes I would see jobs and I wouldn't apply for them because I'm like, I'm not going to get it even if I get it, I going to be able to keep up with the pace? So I think that's how it helped me.

@10:47 - Courtney: Yeah, well that is amazing to hear. What part of the course did you find most engaging and beneficial to your professional development?

@10:55 - Lisa-Pierre: With part of the course. Honestly, it's been a while since I've been the course. think what I like the best is like you know when you first start and you tell you about research in general, what it is, phases, how it's healers to patients and what's involved. think when you get into the degree things of like FDA regulations that was a bit you know it's necessary but it was a bit trickier for me. Yeah so yeah.

@11:23 - Courtney: Okay and then what are some reasons that you would recommend this first to others based on your experience?

@11:28 - Lisa-Pierre: I mean one it's a good thing to boost your CV to see how to certificate from an organization that's you know recognized. Another thing is that I believe that you know you get information and you get knowledge that you wouldn't necessarily get if you don't have any research background and then it's always just deep especially people like me who have like financial restrictions, who can go do a whole bachelor's or master's degree. I think That's a good like it's a good bridge in order to be able to get into research. So, yeah.

@12:07 - Courtney: Yeah, that's great. And last, could you share how your career has advanced into completing the course?

@12:14 - Lisa-Pierre: Yes, so I was able to get a job. I was able to get a job in research at Columbia University, which is yeah, which the department is really renowned for their research. And I think had I not had this certification, I wouldn't have been able to get it as such a prestigious university. I've been at the same company. I've even had people reach out to me to for other clinical jobs, clinical research jobs, sorry. So, I think that this is something that definitely helps because that's basically the only, know, official research being that I have.

@13:00 - Courtney: I think that that's all I need from you for now and then if anybody is going to reach out about just future like if they need some feedback or something like that, then they'll definitely do so. All right. Thank you.

@13:41 - Lisa-Pierre: I hope you have a great day. so much, you too.

You can follow Lisa-Pierre’s career story here.

What Is ICH GCP Certification?

ICH, which stands for the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, is a pivotal global organization shaping the landscape of clinical trials in 2024. Responsible for setting stringent standards, ICH ensures that clinical trials involving human subjects adhere to rigorous regulatory frameworks.

In essence, ICH oversees the implementation of Good Clinical Practice (GCP) guidelines, ensuring that the planning, execution, and documentation of clinical trials are conducted ethically and with scientific integrity at every phase of the research process.

For those seeking to enhance their understanding of ICH GCP guidelines, there's an opportunity to access free online training, providing invaluable insights into the intricacies of conducting ethical and scientifically sound clinical trials in 2024.

You can demo ich gcp training free online here.

What is the purpose of GCP Certification? 

In 2024, GCP Certification, short for Good Clinical Practice Certification, serves as a crucial acknowledgment of an individual's proficiency and expertise in implementing regulatory guidelines across all facets of their work.

Why is it significant?

In the realm of clinical research, possessing GCP certification is indispensable for success. It's not just a matter of preference; it's a necessity. Any organization involved in clinical research endeavors must ensure that their personnel comprehensively grasp the ICH guidelines and are certified to conduct scientific studies accordingly. In fact, many companies provide certification programs for their employees even before they commence their duties. This underscores the paramount importance of GCP certification in the clinical research industry landscape of 2024.ICH GCP Attestation Form

If you're looking to explore a career in the innovative and quickly growing field of clinical research, you'll need to ensure you get the proper Good Clinical Practice certification.

GCP Certification

Are you seeking a GCP refresher online course or comprehensive initial advanced GCP training in 2024? Look no further. Our cutting-edge GCP certification courses are designed to equip you with all the necessary tools to obtain your certification efficiently.

In today's fast-paced world, attending in-person classes for GCP certification training may not always be feasible. That's why our innovative and user-friendly online courses offer a convenient alternative. We understand the importance of receiving top-notch training from experts well-versed in the ICH GCP guidelines to propel your career forward.

At CCRPS, excellence is our standard. Each ICH GCP module we offer is crafted with meticulous attention to detail, ensuring that you receive the highest level of instruction possible. It's time to invest in yourself and receive the refresher training you deserve from professionals who understand how to facilitate your advancement.

Whether you're an ethics committee member, clinical research staff member, or a student embarking on a career in clinical research, our training programs are tailored to meet your needs and set you up for success in the dynamic field of clinical research in 2024.

Good Clinical Practice Training Certificate

How can CCRPS propel your career in 2024?

At CCRPS, we're dedicated to equipping individuals in or aspiring to join the clinical trial industry with the necessary knowledge and training conveniently accessible at their fingertips. We understand that committing hours to classroom study isn't always feasible amidst your professional responsibilities. That's why we've developed our comprehensive GCP refresher course, designed to be completed entirely online.

Enrolling in our course offers you the opportunity to delve into advanced-level content to prepare for your Good Clinical Practice Certification testing.

What benefits await you upon enrollment in our practice training?

While GCP certification is mandatory for all clinical research professionals, its significance is particularly pronounced for certain groups:

• Investigators representing drug companies, research centers, hospitals, and more.

• Members of ethics committees.

• Clinical research staff, including clinical research associates, coordinators, trial managers, etc.

• Students aspiring to enter the clinical research industry.

Who should consider enrolling in CCRPS's groundbreaking training courses?

Whether you're already a seasoned clinical research professional or aspiring to become one, global recommendations underscore the importance of receiving GCP training and certification. Beyond being a minimum requirement, GCP certification holds several key advantages:

• It serves as a formal international validation of an individual's eligibility to work in the clinical research field.

• Organizations and companies rely on GCP-certified professionals to ensure compliance with industry regulations and guidelines.

• GCP training imparts essential knowledge of clinical research regulations to participants.

• Pharmaceutical, biotech companies, and contract research organizations prioritize hiring GCP-certified employees.

In the ever-evolving landscape of the clinical research industry in 2024, ICH GCP training has never been more crucial. Stay ahead of the curve and ensure your knowledge remains current with CCRPS's online practice training courses.

Experience the transformative impact on your clinical research career with our innovative approach to preparation and practice. Elevate your skills and stay abreast of industry developments with CCRPS today!

Download our ICH GCP Attestation Form

Good Clinical Practice GCP Training

Click this link to demo our ICH GCP training free online here!

Good Clinical Practice Training Certificate Syllabus

ICH GCP Resources

E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) 

FDA resource for E6 r2 addendum (also included in course)

Good Clinical Practice Resource Guide

Division of Microbiology and Infectious Diseases December 2015

WHO ICH GCP Handbook

WHO Library Cataloguing-in-Publication Data Handbook for good clinical research practice (GCP):

Guidance for implementation

ICH GCP Jobs

Linkedin Resource of ICH GCP related jobs and roles

GCP Network

Latest trials, website updates, and more

Take courses from CCRPS and learn more on how to become a clinical research professional.

Discover more from Clinical Research Training | Certified Clinical Research Professionals Course

ICH GCP Guidelines

The ICH GCP guidelines provide public assurance that trial subjects' rights, security and well-being are protected in accord with the principles which have their source from Helsinki Declaration. Compliance ensures credible clinical data; 15 points present a unified standard for European Union (EU), Japan & United States to facilitate mutual acceptance by regulatory authorities across those jurisdictions currently compliant with WHO's good practices along side Australia Canada Nordic countries+World Health Organization

This principle has been developed with all their current good clinical practices of the European Union, Japan and USA in addition to those from Australia Canada Nordic countries World Health Organization (WHO). The guidelines established within this document may also be applied during other types medical trials which could have an effect on individual subjects' safety or well being.

ICH GCP Training Free

Here are some ICH GCP training free online guidelines. Make a quizlet or copy the ich gcp guidelines quizlet, then manually rewrite each of these into an individual card that you can easily remember because it's all on one page! To review them more effectively – combine any two cards together if they both pertain to something related in theme (examples: "Committee" & “Implementation”). Continue condensing words and combining sections until down from 50-100 flashcards; after doing so take time out every day this week before your exam(s) for practice reviewing what has been learned thus far by going through each set again slowly but thoroughly while listening carefully

Now you can get internationally accredited ICH GCP certification for $50 through CCRPS course which includes several examples in each video to solidify your knowledge.

ICH GCP Guidelines

The ICH GCP guidelines, including ich gcp e6, provides public assurance that the rights, security and also well-being of trial subjects are protected in accord with the principles which have their source in the Declaration of Helsinki. In addition, compliance ensures credible clinical trial data. The 15 ICH GCP principles presents a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions. The principle has been developed with all their current good clinical practices of the European Union, Japan, and the USA, in Addition to those of Australia, Canada, the Nordic countries and the World Health Organization (WHO). This principle ought to be followed when generating. The principles established in this guideline may also be applied to other clinical investigations which might have an influence on the security and well-being of individual subjects.

ICH GCP Training Free

In order to self-learn ich gcp training free online:

1) make a quizlet account (or use the ich gcp guidelines quizlet)

2) manually rewrite each of the guidelines below into quizlet (this is ESSENTIAL in getting the guidelines to stick in your brain!)

3) continue condensing the words and combining guidelines until you’re down to 50-100 flashcards

4) review set 2-3 times and delete cards to clearly remember

5) continue to review and delete cards until you have it memorized!

While our ICH GCP training course Is only $50 it is essential to learning to applying ich gcp guidelines in an advanced method, you should be able to remotely memorize the guidelines on your own for free as an expert adult learner.

ICH GCP GLOSSARY

While our ICH GCP training course is essential to learning to applying ich gcp guidelines in an advanced method, you should be able to remotely memorize the guidelines on your own for free as an expert adult learner.

1. ICH GCP GLOSSARY

1.1 Adverse Drug Reaction (ADR)

From the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) could not have been established: all noxious and unintended responses to a medicinal product related to any dose ought to be considered adverse drug reactions. The term responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable chance, i.e. the connection can't be ruled out. Regarding marketed medicinal products: a reaction to a drug that is noxious and unintended and that occurs at doses normally utilized in man for prophylaxis, diagnosis, or treatment of diseases or for modification of physiological function (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

1.4 Applicable Regulatory Requirement(s)

Any regulation (s) and law (s) addressing the conduct of clinical trials of investigational products.

1.5 Approval (in relation to Institutional Review Boards)

The affirmative decision of the IRB that the clinical trial was reviewed and could be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the relevant regulatory requirements.

1.7 Audit Certificate
A statement of confirmation by the auditor that an audit has happened. 1.9 Audit Trail
Documentation which allows reconstruction of the class of occasions. 1.10 Blinding/Masking

A process where a couple of parties into this trial are kept unaware of the treatment assignment(s). Single-blinding usually indicates the topic (s) being unaware, and also double-blinding usually indicates the topic (s), investigator(s), track, and, sometimes, data analyst(s) being unaware of the treatment assignment(s).

1.11 Case Report Form (CRF)

A printed, optical, or electronic document designed to record all the protocol required data to be recorded to the sponsor on each trial field.

1.12 Clinical Trial/Study

Any investigation in human subjects meant to discover or verify the clinical, psychiatric or other pharmacodynamic effects of nvestigational product(s), or to identify any adverse reactions to an investigational product(s), or to research absorption, distribution, metabolism, and excretion of an investigational product(s) together with the goal of ascertaining its security and/or effectiveness.

1.13 Clinical Trial/Study Report

A written outline of some trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, where the clinical and statistical description, presentations, and analyses are fully integrated into one report (see the ICH Guideline for Structure and Content of Clinical Study Reports).

1.14 Comparator (Product)

An investigational or marketed product (i.e., active control), or placebo, used as a benchmark in a clinical investigation.

1.15 Compliance (in relation to trials)

Adherence to all of the trial-related needs, Good Clinical Practice (GCP) requirements, and the relevant regulatory requirements.

1.17 Deal

A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and duties , if appropriate, on financial issues. The protocol could serve as the foundation of a contract.

1.18 Coordinating Committee

A committee that a sponsor may organize to coordinate with the behavior of a multicentre trial.

1.19 Coordinating Investigator

An employee assigned the responsibility of the coordination of investigators at several centers participating in a multicentre trial.

1.20 Contract Research Organization (CRO)

A individual or a business (commercial, academic, or other) contracted by the sponsor to do at least one of a host's trial-related responsibilities and purposes.

1.21 Immediate Access

Permission to examine, analyze, verify, and reproduce any records and reports which are important to analysis of a medical trial. Any celebration (e.g., national and international regulatory authorities, sponsor's monitors and auditors) with direct access should take all reasonable measures within the constraints of the applicable regulatory requirement(s) to keep the confidentiality of subjects' identities and sponsor's proprietary information.

1.22 Documentation

All documents, in any kind (such as, but not restricted to, written, digital, magnetic, and optical records, and tests, x-rays, and electrocardiograms) that describe or record the methods, behavior, or effects of a trial, and the factors affecting a trial, and the action taken.

1.23 Critical Documents

Documents that individually and collectively permit evaluation of the behavior of a study and the quality of the data generated.

1.24 Good Clinical Practice (GCP)

A benchmark for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that offers assurance that the data and reported results are credible and accurate, and the rights, ethics, and confidentiality of trial subjects are protected.

1.25 Independent Data-Monitoring Committee (IDMC/Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee)

A separate data-monitoring committee which could be determined by the sponsor to assess at intervals the progress of a clinical trial, the safety information, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, change, or discontinue a trial.

1.26 Impartial Witness

A person, who's independent of this trial, that can't be unfairly influenced by people associated in this trial, who attends the informed consent process if the subject or the subject's legally acceptable representative can't read, and who reads the informed consent form and any other written information provided to the topic.

1.27 Independent Ethics Committee (IEC)

An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of caregivers and non-medical associates, whose duty is to make sure the security of their rights, security and well-being of human issues involved in an investigation and to provide public assurance of the protection, by, among other things, reviewing and approving / providing appropriate view on, the trial procedure, the arrangement of the investigator(s), facilities, and the processes and material to be utilized in obtaining and documenting informed consent of the trial subjects.

1.28 Informed Consent

A procedure in which a subject voluntarily confirms his or her willingness to take part in a specific trial, after being informed of all details of the trial that relate to the subject of choice to engage. Informed consent is documented by way of a written, signed and dated informed consent form.

1.29 Inspection

The action by a regulatory authority(ies) of conducting an official review of documents, records, facilities, and some other sources which are deemed by the authority(ies) to be associated with the clinical trial which could be found in the website of this trial, in the host's or contract study organization's (CRO's) facilities, or at other establishments deemed appropriate by the regulatory authority(ies).

1.30 Institution (medical)

Any private or public entity or agency or medical or dental facility where clinical trials have been conducted.

1.31 Institutional Review Board (IRB)

An independent body constituted of medical, scientific, and non-scientific associates, whose duty is to guarantee the security of their rights, security and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and substance to be utilized in obtaining and documenting informed consent of the trial subjects.

1.33 Investigational Merchandise

A pharmaceutical form of an active ingredient or placebo being tested or used as a benchmark in a clinical trial, such as a product with a marketing authorization when used or assembled (formulated or packaged) in a sense different from the approved form, or if used for an unapproved indication, or when used to get additional information regarding an approved use.

1.34 Partner

A individual accountable for the behavior of this clinical trial at a trial website. When a trial has been conducted by a group of people at a trial site, the investigator is the responsible leader of the group and might be known as the researcher. See also Subinvestigator.

1.35 Investigator / Institution

An expression meaning "the investigator and/or institution, where required by the applicable regulatory requirements".

1.36 Investigator's Brochure

A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects (see 7. Investigator’s Brochure).

1.37 Legally Acceptable Representative

An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial.

1.38 Monitoring

The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

1.39 Monitoring Report

A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs.

1.40 Multicentre Trial

A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator.

1.41 Nonclinical Study
Biomedical studies not performed on human subjects.
1.42 Opinion (in relation to Independent Ethics Committee)
The judgement and/or the advice provided by an Independent Ethics Committee (IEC). 1.43 Original Medical Record
See Source Documents (Below in 1.52).
1.44 Protocol

A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments.

1.45 Protocol Amendment
A written description of a change(s) to or formal clarification of a protocol. 1.46 Quality Assurance (QA)

All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).

1.47 Quality Control (QC)

The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.

1.48 Randomization

The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.

1.49 Regulatory Authorities

Bodies with the power to regulate. In the ICH GCP guideline the expression Regulatory Authorities includes the authorities that review submitted clinical data and those that conduct inspections (see 1.29). These bodies are sometimes referred to as competent authorities.

1.50 Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)

Any untoward medical occurrence that at any dose: - results in death, - is life-threatening, - requires inpatient hospitalization or prolongation of existing hospitalization, - results in persistent or significant disability/incapacity, or - is a congenital anomaly/birth defect (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

1.51 Source Data

All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).

1.52 Source Documents

Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial).

1.53 Sponsor

An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.

1.54 Sponsor-Investigator

An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.

1.55 Standard Operating Procedures (SOPs)

Detailed, written instructions to achieve uniformity of the performance of a specific function.

1.56 Subinvestigator Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). See also Investigator.

1.57 Subject/Trial Subject

An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.

1.58 Subject Identification Code

A unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name when the investigator reports adverse events and/or other trial related data.

1.59 Trial Site
The location(s) where trial-related activities are actually conducted. 1.60 Unexpected Adverse Drug Reaction

An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product) (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

1.61 Vulnerable Subjects

Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

1.62 Well-being (of the trial subjects)
The physical and mental integrity of the subjects participating in a clinical trial.

2. THE PRINCIPLES OF ICH GCP

2.1 Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).

2.2 Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.

2.3 The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.

2.4 The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.

2.5 Clinical trials should be scientifically sound, and described in a clear, detailed protocol.

2.6 A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion.

2.7 The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.

2.8 Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).

2.9 Freely given informed consent should be obtained from every subject prior to clinical trial participation.

2.10 All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.

2.11 The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).

2.12 Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.

2.13 Systems with procedures that assure the quality of every aspect of the trial should be implemented.

3. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)

3.1 Responsibilities

3.1.1 An IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid to trials that may include vulnerable subjects.

3.1.2 The IRB/IEC should obtain the following documents: trial protocol(s)/amendment(s), written informed consent form(s) and consent form updates that the investigator proposes for use in the trial, subject recruitment procedures (e.g. advertisements), written information to be provided to subjects, Investigator's Brochure (IB), available safety information, information about payments and compensation available to subjects, the investigator’s current curriculum vitae and/or other documentation evidencing qualifications, and any other documents that the IRB/IEC may need to fulfil its responsibilities. The IRB/IEC should review a proposed clinical trial within a reasonable time and document its views in writing, clearly identifying the trial, the documents reviewed and the dates for the following: - approval/favourable opinion; - modifications required prior to its approval/favourable opinion; - disapproval / negative opinion; and - termination/suspension of any prior approval/favourable opinion.

3.1.3 The IRB/IEC should consider the qualifications of the investigator for the proposed trial, as documented by a current curriculum vitae and/or by any other relevant documentation the IRB/IEC requests.

3.1.4 The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects, but at least once per year. 3.1.5 The IRB/IEC may request more information than is outlined in paragraph 4.8.10 be given to subjects when, in the judgement of the IRB/IEC, the additional information would add meaningfully to the protection of the rights, safety and/or well-being of the subjects.

3.1.6 When a non-therapeutic trial is to be carried out with the consent of the subject’s legally acceptable representative (see 4.8.12, 4.8.14), the IRB/IEC should determine that the proposed protocol and/or other document(s) adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trials.

3.1.7 Where the protocol indicates that prior consent of the trial subject or the subject’s legally acceptable representative is not possible (see 4.8.15), the IRB/IEC should determine that the proposed protocol and/or other document(s) adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trials (i.e. in emergency situations).

3.1.8 The IRB/IEC should review both the amount and method of payment to subjects to assure that neither presents problems of coercion or undue influence on the trial subjects. Payments to a subject should be prorated and not wholly contingent on completion of the trial by the subject.

3.1.9 The IRB/IEC should ensure that information regarding payment to subjects, including the methods, amounts, and schedule of payment to trial subjects, is set forth in the written informed consent form and any other written information to be provided to subjects. The way payment will be prorated should be specified.

3.2 Composition, Functions and Operations

3.2.1 The IRB/IEC should consist of a reasonable number of members, who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. It is recommended that the IRB/IEC should include: (a) At least five members. (b) At least one member whose primary area of interest is in a nonscientific area. (c) At least one member who is independent of the institution/trial site. Only those IRB/IEC members who are independent of the investigator and the sponsor of the trial should vote/provide opinion on a trial-related matter. A list of IRB/IEC members and their qualifications should be maintained.

3.2.2 The IRB/IEC should perform its functions according to written operating procedures, should maintain written records of its activities and minutes of its meetings, and should comply with GCP and with the applicable regulatory requirement(s).

3.2.3 An IRB/IEC should make its decisions at announced meetings at which at least a quorum, as stipulated in its written operating procedures, is present.

3.2.4 Only members who participate in the IRB/IEC review and discussion should vote/provide their opinion and/or advise.

3.2.5 The investigator may provide information on any aspect of the trial, but should not participate in the deliberations of the IRB/IEC or in the vote/opinion of the IRB/IEC.

3.2.6 An IRB/IEC may invite nonmembers with expertise in special areas for assistance.

3.3 Procedures

The IRB/IEC should establish, document in writing, and follow its procedures, which should include:

3.3.1 Determining its composition (names and qualifications of the members) and the authority under which it is established.

3.3.2 Scheduling, notifying its members of, and conducting its meetings. 3.3.3 Conducting initial and continuing review of trials.
3.3.4 Determining the frequency of continuing review, as appropriate.

3.3.5 Providing, according to the applicable regulatory requirements, expedited review and approval/favourable opinion of minor change(s) in ongoing trials that have the approval/favourable opinion of the IRB/IEC.

3.3.6 Specifying that no subject should be admitted to a trial before the IRB/IEC issues its written approval/favourable opinion of the trial.

3.3.7 Specifying that no deviations from, or changes of, the protocol should be initiated without prior written IRB/IEC approval/favourable opinion of an appropriate amendment, except when necessary to eliminate immediate hazards to the subjects or when the change(s) involves only logistical or administrative aspects of the trial (e.g., change of monitor(s), telephone number(s)) (see 4.5.2).

3.3.8 Specifying that the investigator should promptly report to the IRB/IEC: (a) Deviations from, or changes of, the protocol to eliminate immediate hazards to the trial subjects (see 3.3.7, 4.5.2, 4.5.4). (b) Changes increasing the risk to subjects and/or affecting significantly the conduct of the trial (see 4.10.2). (c) All adverse drug reactions (ADRs) that are both serious and unexpected. (d) New information that may affect adversely the safety of the subjects or the conduct of the trial.

3.3.9 Ensuring that the IRB/IEC promptly notify in writing the investigator/institution concerning: (a) Its trial-related decisions/opinions. (b) The reasons for its decisions/opinions. (c) Procedures for appeal

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of its decisions/opinions.

of its decisions/opinions.

3.4 Records

The IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for a period of at least 3 years after completion of the trial and make them available upon request from the regulatory authority(ies). The IRB/IEC may be asked by investigators, sponsors or regulatory authorities to provide its written procedures and membership lists.

4. INVESTIGATOR

4.1 Investigator's Qualifications and Agreements

4.1.1 The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/IEC, and/or the regulatory authority(ies).

4.1.2 The investigator should be thoroughly familiar with the appropriate use of the investigational product(s), as described in the protocol, in the current Investigator's Brochure, in the product information and in other information sources provided by the sponsor.

4.1.3 The investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements.

4.1.4 The investigator/institution should permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies).

4.1.5 The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties.

4.2 Adequate Resources

4.2.1 The investigator should be able to demonstrate (e.g., based on retrospective data) a potential for recruiting the required number of suitable subjects within the agreed recruitment period.

4.2.2 The investigator should have sufficient time to properly conduct and complete the trial within the agreed trial period.

4.2.3 The investigator should have available an adequate number of qualified staff and adequate facilities for the foreseen duration of the trial to conduct the trial properly and safely.

4.2.4 The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions.

4.3 Medical Care of Trial Subjects

4.3.1 A qualified physician (or dentist, when appropriate), who is an investigator or a sub-investigator for the trial, should be responsible for all trial-related medical (or dental) decisions.

4.3.2 During and following a subject's participation in a trial, the investigator/institution should ensure that adequate medical care is provided to a subject for any adverse events, including clinically significant laboratory values, related to the trial. The investigator/institution should inform a subject when medical care is needed for intercurrent illness(es) of which the investigator becomes aware.

4.3.3 It is recommended that the investigator inform the subject's primary physician about the subject's participation in the trial if the subject has a primary physician and if the subject agrees to the primary physician being informed.

4.3.4 Although a subject is not obliged to give his/her reason(s) for withdrawing prematurely from a trial, the investigator should make a reasonable effort to ascertain the reason(s), while fully respecting the subject's rights.

4.4 Communication with IRB/IEC

4.4.1 Before initiating a trial, the investigator/institution should have written and dated approval/favourable opinion from the IRB/IEC for the trial protocol, written informed consent form, consent form updates, subject recruitment procedures (e.g., advertisements), and any other written information to be provided to subjects.

4.4.2 As part of the investigator's/institution’s written application to the IRB/IEC, the investigator/institution should provide the IRB/IEC with a current copy of the Investigator's Brochure. If the Investigator's Brochure is updated during the trial, the investigator/institution should supply a copy of the updated Investigator’s Brochure to the IRB/IEC.

4.4.3 During the trial the investigator/institution should provide to the IRB/IEC all documents subject to review.

4.5 Compliance with Protocol

4.5.1 The investigator/institution should conduct the trial in compliance with the protocol agreed to by the sponsor and, if required, by the regulatory authority(ies) and which was given approval/favourable opinion by the IRB/IEC.

The investigator/institution and the sponsor must sign the protocol, or another contract, to confirm arrangement.

4.5.2 The investigator shouldn't implement any deviation from, or modifications of this protocol without agreement by the sponsor and prior review and documented approval/favourable opinion in the IRB/IEC of an amendment, except where necessary to eliminate an immediate hazard(s) to trial subjects, or when the change(s) involves only logistical or administrative aspects of the trial (e.g., alter in track (s), change of phone number(s)).

4.5.4 The investigator may implement a deviation from, or a reversal of, the protocol to eliminate an immediate hazard(s) to trial subjects without previous IRB/IEC approval/favourable opinion. When possible, the implemented deviation or change, the causes of this, also, if appropriate, the proposed protocol amendment(s) ought to be filed: (a) into the IRB/IEC for inspection and approval/favourable view, (b) to the sponsor for agreement and, when necessary, (c) into the regulatory authority(ies).

4.6.2 Where allowed/required, the investigator/institution may/should assign some or all the investigator's/institution's duties for investigational product(s) accountability at the trial site(s ) ) to an proper pharmacist or another suitable person who's under the oversight of their investigator/institution. .

4.6.3 The investigator/institution or a pharmacist or other appropriate person, who's given by the investigator/institution, should keep records of their item's delivery to the trial site, the inventory at the website, the usage by each topic, and also the yield to the sponsor or alternative disposition of unused product(s). These records must include dates, numbers, batch/serial numbers, expiration dates (if applicable), and the exceptional code numbers assigned to the investigational product(s) and trial subjects. Researchers should keep records that document adequately that the subjects were provided the doses specified by the protocol and reconcile all investigational product(s) obtained from the host.

4.6.4 The investigational product(s) ought to be kept as defined by the host (see 5.13.2 and 5.14.3) and in compliance with applicable regulatory requirement(s).

4.6.5 The investigator should ensure that the investigational product(s) are utilized only in compliance with the accepted protocol.

4.6.6 The investigator, or a person designated by the investigator/institution, must describe the proper use of the investigational product(s) to each subject and should check, at times appropriate for the trial, that each subject is following the directions correctly. If the trial is blinded, the investigator should promptly document and explain to the sponsor any early unblinding (e.g., accidental unblinding, unblinding because of a serious adverse event) of the investigational product(s).

4.8 Informed Consent of Trial Subjects

4.8.1 In obtaining and documenting informed consent, the investigator must comply with the applicable regulatory requirement(s), and should adhere to GCP and to the ethical principles which have their source in the Declaration of Helsinki. Before the start of the trial, the investigator needs to have the IRB/IEC's composed approval/favourable view of this written informed consent form and any other written information to be offered to subjects.

4.8.2 The written informed consent form and any other written information to be given to subjects must be revised whenever important new information becomes available that may be pertinent to this subject's approval. Any revised written informed consent form, and written advice must get the IRB/IEC's approval/favourable view ahead of usage. The subject or the subject's legally acceptable representative ought to be informed in a timely fashion if new information becomes available that may be pertinent to the subject's willingness to continue participation in the trial. The communication of the information ought to be documented.

4.8.5 The investigator, or a person designated by the investigator, should fully inform the subject or, even if the topic is not able to give informed consent, the subject's legally acceptable representative, of all pertinent aspects of the trial including the written advice and also the approval/ favourable opinion by the IRB/IEC.

4.8.6 The language used in the written and oral information regarding the trial, including the written informed consent form, must be non-technical as functional and should be clear to the subject or the subject's legally acceptable representative and the impartial witness, where applicable.

4.8.7 Before informed consent may be obtained, the investigator, or someone designated by the investigator, should offer the subject or the subject's legally acceptable representative ample time and opportunity to ask about details of the trial and also to choose whether or not to take part in the trial. All queries concerning the trial ought to be answered to the satisfaction of the topic or the subject's legally acceptable representative.

4.8.8 Before a subject's involvement in the analysis, the written informed consent form ought to be signed and dated by the topic or from the subject's legally appropriate agent, and from the man who conducted the informed consent discussion.

4.8.9 If a topic can't read or if a legally acceptable representative is not able to read, an impartial witness should be present throughout the entire informed consent discussion. Following the written informed consent form and any other written information to be given to subjects, will be read and explained to the subject or the subject's legally acceptable representative, and after the subject or the subject's legally acceptable representative has orally consented to the subject of involvement in the trial and, if capable of doing this, has signed and dated the informed consent form, the witness must sign and personally date the consent form. (b) The intention of the trial. If there's not any intended clinical benefit to the subject, the topic ought to be made aware of the (I) The alternative procedure(s) or course(s) of treatment which could be accessible to the matter, and their important potential benefits and hazards. (j) The reimbursement and/or therapy readily available to the subject at case of trial-related injury. (l) The anticipated expenses, if any, to the subject of participating in the trial. (n) The monitor(s), the auditor(s), the IRB/IEC, along with the regulatory authority(ies) will be granted direct entry to the subject's original medical records for verification of clinical trial processes and/or information, without violating the confidentiality of this topic, to the extent allowed by the applicable legislation and regulations and that, by signing a written informed consent form, the subject or the subject's legally acceptable representative is authorizing such access. (o) That records identifying the subject will be kept confidential and, to the extent allowed by regulations or laws, won't be made publicly accessible. If the outcomes of the trial have been published, the subject's identity will stay confidential. (p) The subject or the subject's legally acceptable representative will be informed in a timely manner if information becomes available that may be pertinent to the subject's willingness to continue participation in the trial. (q) The individual (s) to contact for more information concerning the trial and the rights of trial subjects, and whom to contact in case of trial-related injury. (r) The foreseeable conditions and/or motives under the subject's involvement in the trial could be terminated. (s) The expected duration of the subject's involvement in the trial. (t) The approximate number of subjects included with the trial.

4.8.11 Prior to participation in the trial, the subject or the subject's legally acceptable representative should be given a copy of the signed and dated written informed consent form and any other written information supplied to the topics. During a subject's involvement in the trial, the subject or the subject's legally acceptable representative should get a copy of the signed and dated consent form updates and a copy of any amendments to the written information given to subjects.

4.8.12 When a clinical trial (therapeutic or non-therapeutic) includes subjects who can only be registered in the trial with the permission of the subject's legally acceptable representative (e.g., minors, or individuals with severe dementia), the subject ought to be informed about the trial to the extent compatible with the subject of comprehension and, if capable, the subject should sign and personally date the written informed consent.

4.8.13 Except as described in 4.8.14, a non-therapeutic trial (i.e. a trial where there is not any anticipated direct clinical benefit to the subject), needs to be conducted in subjects who give consent and that sign and date the written informed consent form.

4.8.14 Non-therapeutic trials might be conducted in subjects with consent of a legally acceptable representative provided that the following requirements are fulfilled: (a) The aims of the trial can't be fulfilled by way of a trial in subjects that can provide informed consent. (c) The adverse influence on the subject's well-being is reduced and minimized. (d) The trial isn't prohibited by legislation. (e) The approval/favorable view of this IRB/IEC is especially sought on the inclusion of these topics, and the written approval/ favorable opinion covers this aspect. Topics in such trials must be particularly closely monitored and must be removed if they seem to be overly distressed.

4.8.15 In crisis situations, when prior permission of the subject isn't feasible, the permission of the subject's legally acceptable representative, if present, should be asked. When previous consent of the topic isn't feasible, along with the subject's legally acceptable representative isn't available, enrollment of this topic ought to require steps described in the protocol or elsewhere, with recorded approval/favorable opinion from the IRB/IEC, to safeguard the rights, security and well-being of this topic and also to guarantee compliance with applicable regulatory requirements. The subject or the subject's legally acceptable representative ought to be informed about the trial when possible and agree to continue along with additional approval as appropriate (see 4.8.10) ought to be asked.

4.9 Records and Reports

4.9.1 The investigator should ensure the accuracy, completeness, legibility, and timeliness of their information reported to the host at the CRFs and in all necessary reports.

4.9.2 Data reported on the CRF, which are derived from source documents, ought to be in accordance with the source documents or the discrepancies should be clarified.

4.9.3 Any alteration or correction to a CRF ought to be dated, initialed, and explained (if necessary) and shouldn't obscure the original entry (i.e. an audit trail ought to be preserved ); that applies to both written and electronic changes or corrections (visit 5.18.4 (n)). Sponsors should provide advice to investigators or the researchers' designated representatives on making such corrections. Sponsors must have written procedures to ensure corrections or changes in CRFs created by sponsor's designated agents are recorded, are needed, and are backed by the investigator. The investigator must maintain records of the corrections and changes.

4.9.4 The investigator/institution must keep the trial documents as stated in Essential Documents for the Conduct of a Clinical Trial (see 8.) The investigator/institution must take steps to avoid accidental or premature destruction of those records.

4.9.5 Essential documents should be retained until at least two years following the final approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least two years have elapsed since the formal discontinuation of clinical development of the investigational item. These records should be kept for a longer period however if required by the relevant regulatory requirements or by having an arrangement with the host. It's the obligation of the host to notify the investigator/institution concerning when these documents no longer have to be kept (see 5.5.12).

4.9.6 The financial details of the trial ought to be recorded in an agreement between the host and the investigator/institution.

4.9.7 Upon request of the monitor, auditor, IRB/IEC, or regulatory authority, the investigator/institution must make readily available for direct access all requested trial-related documents.

4.10 Progress Reports

4.10.1 The investigator must submit written summaries of this trial status to the IRB/IEC yearly, or more often, if asked by the IRB/IEC.

4.10.2 The investigator should promptly provide written reports on the host, the IRB/IEC (see 3.3.8) and, where applicable, the institution on any changes significantly affecting the behavior of this trial, or raising the risk to subjects. The follow-up and immediate reports must identify subjects by unique code numbers assigned to the trial subjects instead of from the subjects' names, personal identification numbers, or addresses. The investigator must also comply with the applicable regulatory requirement(s) associated with the reporting of unexpected serious adverse drug reactions to the regulatory authority(ies) along with the IRB/IEC.

4.11.2 Adverse laboratory or events abnormalities identified in the protocol as critical to safety evaluations should be reported to the host in line with the coverage requirements and within the time intervals specified by the host in the protocol.

4.12 Premature Termination or Suspension of a Trial

In case the trial is prematurely terminated or suspended for any reason, the investigator/institution should immediately inform the trial issues, should guarantee proper treatment and follow-up for those issues, and, where required by the applicable regulatory requirement(s), should notify the regulatory authority(ies). Additionally:

4.12.1 If the investigator terminates or suspends a trial without prior agreement of the host, the investigator must inform the institution where applicable, and also the investigator/institution should immediately notify the host and the IRB/IEC, and should offer the sponsor along with the IRB/IEC a detailed written explanation of the termination or suspension.

4.12.2 If the sponsor terminates or suspends a trial (see 5.21), the investigator must immediately notify the institution where applicable along with the investigator/institution should immediately inform the IRB/IEC and supply the IRB/IEC a detailed written explanation of the termination or suspension.

4.12.3 When the IRB/IEC terminates or suspends its approval/favorable view of a trial (see 3.1.2 and 3.3.9), the investigator must inform the institution where applicable along with the investigator/institution should immediately notify the host and supply the sponsor with a detailed written explanation of the termination or suspension.

4.13 Final Report(s) by Investigator

Upon completion of the trial, the investigator, where relevant, should notify the institution; the investigator/institution must offer the IRB/IEC using a review of the trial's result, and the regulatory authority(ies) with any reports required.

5. SPONSOR

5.1 Quality Assurance and Quality Control

5.1.1 The host is responsible for implementing and maintaining quality assurance and quality management systems with written SOPs to make certain that trials are conducted and data are generated, documented (recorded), and documented according to the protocol, GCP, and the applicable regulatory requirement(s).

5.1.2 The host is responsible for securing agreement from all involved parties to ensure immediate access (see 1.21) to each of trial related websites, origin data/documents, and reports for the purpose of monitoring and auditing by the sponsor, and review by domestic and international regulatory authorities.

5.1.3 Quality control ought to be applied to every point of data handling to make sure that all data are reliable and have been processed properly.

5.1.4 Agreements, created by the host with all the investigator/institution and some other parties involved with the clinical trial, must be in writing, within this protocol or in another arrangement.

5.2 Contract Research Organization (CRO)

5.2.1 A sponsor may transfer any or all the host's trial-related responsibilities and functions to a CRO, but the ultimate responsibility for its integrity and quality of the trial data always resides with the host. The CRO should apply quality assurance and quality management.

5.2.2 Any trial-related responsibility and function that's transferred to and assumed by a CRO ought to be given in writing.

5.2.3 Any trial-related responsibilities and functions not specifically transferred to and assumed by a CRO are retained by the host.

5.2.4 All references to a host within this guideline apply to a CRO to the extent that a CRO has assumed the trial related duties and functions of a host.

5.3 Medical Experience

The sponsor must designate suitably qualified medical staff that are easily available to counsel trial related health questions or issues. If needed, external advisor (s) can be made for this function.

5.4 Trial Design

5.4.1 The host must use qualified people (e.g. biostatisticians, clinical pharmacologists, and physicians) as appropriate, during all phases of their trial process, in designing the protocol and CRFs and preparing the investigations into assessing and preparing interim and final clinical trial reports.

5.5 Trial Management, Data Handling, and Record Keeping i.e. ICH GCP guidelines for clinical data management

5.5.1 The host must use appropriately qualified people to supervise the general conduct of this trial, to deal with the information, to confirm the information, to conduct the statistical analyses, and also to prepare the demo reports. The IDMC should have written operating procedures and keep written records of its meetings.

5.5.3 When using electronic trial data management and/or remote electronic trial information programs, the host needs to: (a) Ensure and document that the electronic data processing procedure(s) adheres to the sponsor's established requirements for completeness, accuracy and reliability, and consistent intended performance (i.e. identification ). (b) Maintains SOPs for utilizing such systems. (c) Make sure that these systems are intended to allow data changes in such a manner in which the data changes are documented and that there isn't any deletion of input data (i.e. keep an audit trail, information path, edit path ). (d) Keep a safety system which prevents unauthorized access into this information. (e) Keep a listing of those people that are licensed to produce information modifications (see 4.1.5 and 4.9.3). (g) Shield the blinding, if some (e.g. keep the data during data entry and processing system ).

5.5.4 When data are transformed during processing, then it must remain possible to evaluate the initial observations and data with the data that is processed.

5.5.5 The host must utilize an unambiguous subject identification code (visit 1.58) which enables identification of all of the information reported for every topic.

5.5.6 The host, along with other owners of all this information, should keep each the sponsor-specific necessary documents of interest to the trial (see 8).

5.5.7 The sponsor must maintain all sponsor-specific necessary files in conformance with all the applicable regulatory requirement(s) of this country(ies) in which the item is accepted, or at which the sponsor intends to submit an application for approval(s).

5.5.9 If the sponsor discontinues the clinical development of an investigational solution, the sponsor must notify all of the trial investigators/institutions and most of the regulatory authorities.

5.5.10 Any transfer of possession of this information must be reported on the proper authority(ies), according to the applicable regulatory requirement(s).

5.5.12 The sponsor must notify the investigator(s)/association(s) in writing of their requirement for document retention and should inform the investigator(s)/association(s) in writing whenever the trial associated documents are no more needed.

5.6 Investigator Choice

5.6.1 The host is responsible for picking the investigator(s)/association (s). Each investigator ought to be qualified by experience and training and should have sufficient funds (see 4.1, 4.2) to properly conduct the trial where the investigator is chosen. If business of some coordinating committee or choice of coordinating investigator(s) will be used in multicentre trials, their company and/or choice are the host's responsibility.

5.6.2 Before entering an agreement with an investigator/institution to perform a trial, the sponsor must offer the investigator(s)/association (s) using the routine and also an up-to-date Investigator's Brochure, and should provide adequate time for your investigator/institution to assess the protocol and also the info supplied.

5.6.3 The sponsor must obtain the investigator's/institution's arrangement: (a) to conduct the trial according to GCP, together with all the applicable regulatory requirement(s) (see 4.1.3), also with the protocol agreed to by the host and given approval/favorable remark by the IRB/IEC (see 4.5.1); (b) to comply with processes for information recording/reporting; (c) to allow tracking, auditing and review (see 4.1.4) and (d) to keep the trial associated essential files until the host informs the investigator/institution that these records are no longer required (see 4.9.4 along with also 5.5.12). The host and the investigator/institution need to sign the protocol, or an alternate file, to verify this arrangement.

5.7 Allocation of Duties

Before initiating a trial, the sponsor should define, establish, and devote most of of trial-related responsibilities and purposes.

5.8 Compensation to Subjects and Investigators

5.8.1 If required by the applicable regulatory requirement(s), the host must offer insurance or if indemnify (valid and fiscal policy ) that the investigator/the association against claims arising out of the trial, and except for claims that arise from prosecution and/or neglect.

5.8.2 The host's policies and procedures must deal with the expenses of treatment for trial issues in case of trial-related accidents in agreement with the applicable regulatory requirement(s).

5.8.3 When identification subjects receive reimbursement, the procedure and way of reimbursement must comply with applicable regulatory requirement(s).

5.9 Funding

The financial facets of the trial ought to be recorded in an agreement between the host and the investigator/institution.

5.10 Notification/Submission into Regulatory Authority(ies)

Prior to initiating the clinical investigation (s), the host (or the host and the investigator, even when necessary by the applicable regulatory requirement(s)) must submit any necessary program (s) into the proper authority(ies) for inspection, approval, and/or consent (as needed by the applicable regulatory requirement(s)) to commence the trial(s). Any notification/submission ought to be dated and include adequate information to recognize the routine. (b) A statement obtained in the IRB/IEC it is organized and functions in accordance with GCP and the applicable regulations and laws. (c) Documented IRB/IEC approval/favourable view and, when requested by the host, a recent backup of protocol, written informed consent form(s) and any other written information to be offered to areas, subject recruiting processes, and records associated with payments and reimbursement available to the topics, and some other files the IRB/IEC could have asked.

5.11.2 If the IRB/IEC states its approval/favourable view upon modification (s) in almost any feature of the trial, including alteration (s) of this protocol, written informed consent form and any other written information to be offered to areas, or other processes, the sponsor must obtain in the investigator/institution that a duplicate of the modification(s) created and the date approval/favourable remark was given from the IRB/IEC.

5.11.3 The sponsor must obtain in the investigator/institution dates and documentation of any IRB/IEC reapprovals/re-evaluations with hierarchical view, also of any withdrawals or suspensions of all approval/favourable view.

5.12 Information on Investigational Product(s) 5.12.1 When planning trials, the sponsor must ensure that adequate safety and efficacy information from nonclinical clinical or studies trials are readily available to support human vulnerability from the path, in the doses, for its length, and at the trial population to be analyzed.

5.12.2 The host must upgrade the Investigator's Brochure as important new information becomes available (see 7).

5.13 Manufacturing, Packaging, Labeling, and Coding Investigational Product(s)

5.13.1 The host should ensure that the investigational product(s) (such as active comparator(s) and placebo( if appropriate ) is distinguished as appropriate for the stage of growth of the item (s), is fabricated according to any relevant GMP, and can be coded and tagged in a way that safeguards the blinding, if appropriate. Additionally, the labelling must comply with all applicable regulatory requirement(s).

5.13.2 The sponsor must determine, for the investigational product(s), decent storage temperatures, storage requirements (e.g. protection against mild ), storage times, reconstitution fluids and processes, and apparatus for product extract, if any. The host should notify all parties that are involved (e.g. tracks, researchers, pharmacistsand storage managers) of those determinations.

5.13.3 The investigational product(s) ought to be packed to avoid contamination and improper deterioration during storage and transport.

5.13.4 In clinical trials, the programming system to its investigational product(s) must incorporate a mechanism which allows rapid identification of their item (s) if a health crisis, but doesn't permit imperceptible fractures of this blinding.

5.13.5 If significant formulation changes are produced in the investigational or comparator product(s) throughout the course of clinical improvement, the outcomes of some further studies of the formulated product(s) (e.g. stability, dissolution rate, bioavailability) required to evaluate whether these changes could significantly alter the pharmacokinetic profile of this item ought to be available before using this newest formula in clinical trials.

5.14 Supplying and Handling Investigational Product(s)

5.14.1 The host is responsible for providing the investigator(s)/association (s) using all the investigational product(s ) ).

5.14.2 The host shouldn't provide an investigator/institution using the investigational product(s) before the host obtains all necessary documentation (e.g. approval/favorable view from IRB/IEC and regulatory authority(ies)).

5.14.3 The host must ensure that written procedures contain directions the investigator/institution must follow to the storage and handling of investigational product(s) for your trial and documentation . The processes should address decent and safe receipt, handling, storage, unloading, recovery of fresh product in issues, and yield of unused investigational product(s) to the host (or other disposition if approved by the host and in accordance with all the applicable regulatory requirement(s)).

5.14.4 The host needs to: (a) guarantee timely delivery of investigational product(s) into this investigator(s). (b) Keep records that document dispatch, receipt, disposition, reunite, and also destruction of this investigational product(s) (see 8). (c) Maintain a method for regaining investigational products and recording that this recovery (e.g. for deficient product remember, recover after trial completion( expired merchandise recover ).

5.14.5 The host needs to: (a) Take action to make certain that the investigational product(s) are steady over the length of usage. (b) Maintain adequate quantities of the investigational product(s) utilized from the trials to reconfirm specifications, so should it be necessary, and keep records of batch sample investigations and attributes. To the degree equilibrium allows, samples must be kept either before the investigations of the trial data will be complete or as needed by the applicable regulatory requirement(s), whichever reflects the longer retention interval.

5.15 Record Access

5.15.1 The host must ensure it is given in the protocol or other written agreement which the investigator(s)/association (s) offer immediate access to source data/documents such as trial- related observation, Tests, IRB/IEC inspection, and regulatory review.

5.15.2 The host must verify that every subject has agreed, in writing, to guide accessibility to their own first medical records to get trial-related observation, audit, IRB/IEC inspection, and regulatory scrutiny.

5.16.2 The sponsor must immediately notify all concerned investigator(s)/association (s) and the regulatory authority(ies) of findings which could affect negatively the security of topics, affect the behavior of this trial, or change the IRB/IEC's approval/favourable view to keep the test.

5.17.3 The sponsor must submit to the regulatory authority(ies) all security upgrades and periodic reports, and according to applicable regulatory requirement(s).

5.18 Tracking

5.18.1 Purpose

The functions of trial monitoring are to confirm: (a) The rights and also well-being of individual subjects are protected. (c) The conduct of the offense will be in accordance with the approved protocol/amendment(s), with GCP, along with all the applicable regulatory requirement(s). (b ) Monitors must be suitably trained, and ought to possess the clinical or scientific knowledge required to track the trial satisfactorily. A track's qualifications must be recorded.

5.18.3 Extent and Nature of Monitoring

The host should ensure that the trials have been adequately tracked. The sponsor must determine the right scope and nature of observation. The conclusion of the scope and nature of monitoring should be determined by factors like the purpose, function, style, complexity, blinding, size, and endpoints of this trial. Generally speaking there's a demand for onsite observation, before, during, and after the trialhowever in extraordinary circumstances the host may decide that central observation in combination with processes such as researchers' meetings and training, and comprehensive written advice can assure proper conduct of the trial in agreement with GCP. Statistically controlled sampling could be an acceptable way of selecting the information to be checked.

5.18.4 Monitor's Responsibilities

The track (s) in compliance with the host's requirements need to make sure that the trial will be conducted and recorded properly by executing the following actions when relevant and essential to this trial and the crime website: (a) Acting as the major field of communication between the host and the investigator. (b) Verifying that the investigator has sufficient qualifications and tools (see 4.1, 4.2, 5.6) and stay adequate throughout the trial period, which facilities, such as labs and equipment, and employees, are sufficient to safely and properly conduct the trial and stay adequate throughout the trial period. (ii) The investigational product(s) are provided exclusively to subjects that are qualified for it and in the protocol given dose(s). (iii) That matters are supplied with necessary education on correctly using, managing, storing, and returning to the investigational product(s). (iv) The reception, use, and yield of this investigational product(s) in the trial sites are regulated and recorded adequately. (v) The disposition of unused investigational product(s) in the trial sites complies with all applicable regulatory requirement(s) and can be in accord with the sponsor. (e) Verifying that written informed consent was obtained prior to each subject's involvement in this trial. (f) Ensuring that the investigator gets the current Investigator's brochure, all records, and all of the trial provides required to conduct the trial properly and also to comply with the applicable regulatory requirement(s). (h) Verifying that the investigator and the investigator's trial staff are currently still doing the given trial purposes, in accord with the protocol along with another written agreement between the host and the investigator/institution, also haven't assigned the functions to unauthorized people. (I) Verifying that the investigator will be enroling only qualified subjects. (j) Reporting the matter recruitment rate. (k) Verifying that source files and other trial documents are true, complete, retained up-to-date and preserved. (Id) Verifying that the investigator provides all of the essential documents, notifications, applications, and admissions, and these records are accurate, comprehensive, timely, legible, dated, and also establish that the trial. (m) Assessing the accuracy and completeness of the CRF entries, source files and other trial-related documents contrary to each other. The monitor especially should confirm that: (I) The information required by the protocol have been reported right about the CRFs and therefore are in accordance with the source files. (ii) Any dose or treatment alterations are well documented for all the trial issues. (iii) Adverse events, concomitant medications and inter-current disorders are reported with regard to the routine in the CRFs. (iv) Visits the subjects don't create, tests which aren't conducted, and tests which aren't performed are reported as such on the CRFs. (n) Informing the inheritance of any CRF entrance mistake, omission, or illegibility. The monitor must ensure that proper adjustments, additions, or deletions are made, obsolete, clarified (if needed ), and initialed by the investigator or from a part of the investigator's trial staff who's licensed to first CRF modifications to your investigator. This consent ought to be documented. (o) Deciding whether adverse events (AEs) are reported over the time intervals required by GCP, the protocol, the IRB/IEC, the host, as well as the applicable regulatory requirement(s). (de) Deciding if the investigator is keeping the vital files (see 8. )

5.18.5 Monitoring Procedures

The track (s) must occur after the host's established written SOPs in addition to those processes which are given by the host for tracking a particular trial.

5.18.6 Monitoring Report

(a) The screen must submit an official report to the host after every trial-site see or trial-related communication. (b) Reports must include the date, website, title of the track, and title of the investigator or other person (s) contacted. (c) Reports must include a summary of the track reviewed along with the track's statements regarding the substantial findings/facts, deviations and deficiencies, decisions and actions taken or to be obtained and/or activities recommended to procure compliance. (d) The follow-up and review of this observation report with all the host ought to be recorded by the host designated agent.

5.19 Audit

When Patrons Execute audits, as a Part of Executing quality assurance, they Ought to Think about: 5.19.1 Purpose

The purpose of a host's audit, that will Be independent of and different from regular monitoring or quality control purposes, is to assess trial behavior and compliance with the protocol, SOPs, GCP, and the applicable regulatory requirements.

5.19.2 Selection and Qualification of Auditors

(a) The sponsor must appoint individuals, that are independent of their clinical trials/systems, to run research. (b) The sponsor should make sure that the auditors are qualified by experience and training to conduct audits properly. An auditor's qualifications must be recorded.

5.19.3 Auditing Procedures

(a) The sponsor should ensure that the auditing of clinical trials/systems is conducted with respect to the sponsor's written procedures about which to audit, the way to study, the frequency of analysis, as well as the shape and content of reports. (b) The host's audit program and processes for a trial should be directed by the value of the trial to admissions to regulatory authorities, the amount of subjects from the trial, and the form and complexity of the trial, and the amount of threats to the trial issues, along with also any identified issue (s). (c) The findings and observations of the auditor(s) ought to be documented. (d) To maintain the freedom and importance of the audit function, the regulatory authority(ies) shouldn't routinely ask the audit accounts. Regulatory authority(ies) could find entry to an audit report on a case by case basis if signs of critical GCP non-compliance is present, or even in the course of legal proceeding. (e) If required by applicable law or regulation, the host must offer an audit certification.

5.20 Noncompliance

5.20.1 Noncompliance with all the protocol, SOPs, GCP, or relevant regulatory requirement(s) with an investigator/institution, or from member(s)) of their host's staff should result in prompt action from the host to secure compliance.

5.20.2 in the event the observation and/or auditing describes long-term or serious noncompliance on the part of an investigator/institution, then the host must terminate the employee's /institution's involvement at the trial. Once an investigator's/institution's participation is terminated due to noncompliance, the host must notify immediately the regulatory authority(ies).

5.21 Premature Termination or Suspension of a Trial

When a trial is prematurely terminated or suspended, then the host should immediately inform the investigators/institutions, along with the regulatory authority(ies) of their conclusion or suspension and the reason(s) for the termination or suspension. The IRB/IEC also needs to be advised promptly and given the rationale (s) for the termination or suspension from the host or from the investigator/institution, according to the applicable regulatory requirement(s).

5.22 Clinical Trial/Study Reports When the trial has been completed or terminated, the sponsor should make certain that the clinical trial accounts are prepared and supplied to the regulatory agency(ies) according to the applicable regulatory requirement(s). The host must also make sure that the clinical trial reports in advertising programs meet the criteria of this ICH Guideline for Structure and Content of Clinical Study Reports. (NOTE: The ICH Guideline for Structure and Content of Clinical Study Reports reveal that abbreviated study reports may be appropriate in certain instances.)

5.23 Multicentre Trials For multicentre trials, the sponsor must make sure that:

5.23.1 All researchers conduct this trial from strict compliance with the protocol agreed to by the host and, if necessary, from the regulatory authority(ies), also awarded approval/favorable remark by the IRB/IEC.

5.23.2 The CRFs are made to capture the essential information at all multicentre trial websites. For those researchers that are collecting further information, supplemental CRFs must also be supplied that are intended to capture the extra data.

5.23.3 The duties of coordinating investigator(s) along with another participating investigators are recorded before the beginning of the trial.

5.23.4 All researchers are given directions on after the protocol, to complying with a uniform set of criteria for the evaluation of clinical and laboratory findings, and on finishing the CRFs.

6. But site specific advice might be given on separate protocol page(s), or handled in another agreement, and a few of the info listed below can be included in other protocol referenced documents, including an Investigator's Brochure. Any modification (s) must also bear the amendment number(s) and date(s).

6.1.3 Name and name of the individual (s) authorized to sign the protocol and the protocol change (s) for your host.

6.1.4 Name, name, address, and phone number(s) of their host's medical practitioner (or dentist when appropriate) for the offense.

6.1.5 Name and name of the investigator(s)) who is/are responsible for conducting the trial, along with the address and phone number(s) of the trial site(s).

6.1.6 Name, name, address, and phone number(s)) of the qualified physician (if appropriate), who's accountable for many trial-site associated medical (or dental) decisions (if other than investigator).

6.1.7 Title (s) and address(es) of the clinical laboratory(ies) and other technical or medical section (s) and/or associations involved with the trial.

6.2 Background Information

6.2.1 Title and description of the investigational product(s).

6.2.2 A list of findings in nonclinical studies that potentially have clinical significance and from clinical trials which are linked to this trial.

6.2.3 Summary of the known and possible risks and advantages, if any, to human subjects.

6.2.5 An announcement that the trial will be run in accordance with the protocol, GCP and the applicable regulatory requirement(s).

6.2.6 Description of the population to be researched.

6.2.7 References to literature and information which are related to the trial, which provide background for your trial.

6.3 Trial Objectives and Purpose

A comprehensive outline of the goals and the objectives of the trial.

6.4 Trial Design

The scientific integrity of this trial and the trustworthiness of the information from the trial depend considerably on the trial layout. A description of the trial design, must contain:

6.4.1 A particular statement of the principal endpoints and the secondary endpoints, if any, to be measured throughout the trial.

6.4.2 An outline of this type/design of trial must be performed (e.g. double sided, placebo-controlled( parallel design) and a schematic diagram of trial design, processes and phases.

6.4.3 A description of the measures required to minimize/avoid prejudice, such as: (a) Randomization.

6.4.4 An outline of the trial treatment(s) and the dose and dose regimen of the investigational product(s).

6.4.5 The expected duration of subject participation, and a description of this order and duration of all trial periods, such as followup, if any.

6.4.6 A description of the"stopping rules" or"discontinuation criteria" for different topics, elements of trial and complete trial.

6.4.9 The identification of any data to be recorded directly on the CRFs (i.e. no previous written or electronic record of data), also also to be regarded as source data. (b) The type and timing of this information to be collected for withdrawn subjects. (d) The followup to subjects withdrawn from investigational product treatment/trial therapy.

6.6 Treatment of Topics

6.6.1 The remedy (s) has to be treated, including the name(s) of the item (s), the dose(s), the dosing schedule(s), the route/mode(s) of government, and the treatment period(s), for instance, follow-up interval (s) for subjects for each investigational product treatment/trial therapy group/arm of this trial.

6.6.2 Medicine (s)/treatment(s) permitted (including rescue medication) and not allowed before or throughout the trial.

6.7.2 Methods and timing for assessing, recording, and assessing of efficiency parameters. 6.8.2 The timing and methods for assessing, recording, and assessing safety parameters. 6.8.4 The kind and length of the followup of subjects after adverse events.
6.9 Statistics

6.9.1 A number of the statistical techniques to be employed, including timing of any planned interim analysis(ses).

6.9.2 the amount of subjects planned to be registered.
6.9.3 the degree of importance to be utilized. 6.9.4 Criteria for the conclusion of this trial.

6.9.6 Procedures for reporting any deviation(s) from the original statistical plan (any form (s) from the original statistical plan ought to be clarified and justified from protocol or in the last report( as appropriate).

6.9.7 The choice of topics must be included in the investigations (e.g. all distinct subjects, all dosed subjects, all eligible subjects, evaluable subjects).

6.10 Direct Access to Source Data/Documents The host must ensure it is given in the protocol or other written agreement that the investigator(s)/association (s) will allow trial-related tracking, audits,

IRB/IEC inspection, and regulatory review (s), providing immediate access to supply data/documents.

IRB/IEC inspection, and regulatory review (s), providing immediate access to supply data/documents. 6.13 Data Handling and Record Keeping

6.14 Financing and Insurance Coverage Financing and insurance if not addressed in a separate arrangement.

6.15 Publication Policy Publication policy, if not handled in another agreement. 6.16 Supplements (NOTE: As the protocol along with the clinical trial/study document are closely linked, additional relevant information is found at the ICH Guideline for Structure and Content of Clinical Study Reports.)

INVESTIGATOR'S BROCHURE

7.1 Introduction

The Investigator's Brochure (IB) is a set of the clinical and nonclinical data on the investigational product(s) which relate to the analysis of the merchandise (s) in human subjects. Its objective is to deliver the researchers and others involved with the trial using all the data to facilitate their comprehension of the rationale behind, and their compliance with, several important features of this protocol, like the dosage, dosage frequency/interval, techniques of management: and security monitoring processes. The IB also gives insight to help the clinical direction of their research subjects throughout the course of this clinical trial. The info ought to be displayed in a concise, simple, objective, balanced, and also non-promotional type that allows an individual clinician, or possible investigator, to comprehend it and create his unbiased risk-benefit evaluation of the appropriateness of the planned trial. Because of this a medically qualified individual should normally take part in the screening of an IB, however, the contents of the IB must be accepted by the areas that created the described information. This guideline delineates the minimal information which needs to be contained within an IB and gives tips for its design. It's anticipated that the kind and degree of information available will change with the period of growth of the investigational item. If the investigational product is promoted and its pharmacology is broadly known by medical professionals, a comprehensive IB might not be vital. Where permitted by law enforcement, a fundamental product information booklet, package leaflet, or data could possibly be an proper choice, given that it comprises comprehensive, current, and comprehensive advice on all parts of the investigational product which may be of significance to this investigator. If a promoted product has been analyzed for a new usage (i.e., a brand new sign ), an IB unique to this new use ought to be ready. The IB must be evaluated at least annually and revised as required in accordance with a host's written procedures. More regular revision could be appropriate based on the phase of evolution and the creation of relevant new info. Nonetheless, in accordance with Good Clinical Nutrition, pertinent new information might be so significant that it needs to be conveyed to the researchers, and maybe into the Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) or regulatory governments before it's contained in a revised IB. Usually, the host is responsible for ensuring an up- to-date IB is made accessible for the investigator(s) and the researchers are responsible for supplying the up-to-date IB into the accountable IRBs/IECs. In the instance of a worker sponsored trial, then the sponsor-investigator must find out if a booklet is available in the industrial maker. If the investigational product is supplied by this sponsor-investigator, then they must offer the essential info to the trial staff. In scenarios when planning of a proper IB is impractical, the sponsor-investigator must supply, as a replacement, an enlarged background information element in the trial procedure which includes the minimal present data described within this principle.

7.2 General Considerations the IB should comprise:

7.2.1 Title Page

This ought to offer the host's name, the identification of every investigational product (i.e., study number, compound or accepted generic title, and transaction name(s) where legally permissible and desired by the host), along with also the launch date. It's also suggested an edition number, and a reference to this date and number of the variation that it supersedes, be supplied. A good instance is provided in Appendix 1.

7.2.2 Confidentiality Statement

The sponsor might desire to incorporate a statement instructing the investigator/recipients to take care of the IB as a private record for the only information and usage of this investigator's team along with the IRB/IEC.

7.3 Contents of the Investigator's Brochure

The IB should include these segments, each with literature references where appropriate: 7.3.1 Table of Contents An illustration of the Table of Contents is provided at Appendix 2

7.3.2 Summary

A short summary (preferably not exceeding two pages) ought to be granted, highlighting the substantial physical, chemicaland pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic, and clinical data available that's pertinent to this point of clinical development of the investigational item.

7.3.3 Introduction

A short introductory statement ought to be provided that includes the compound name (and generic and trade name(s) when accepted ) of the investigational product(s), all active components, the investigational product (s) pharmacological category and its expected location in this category (e.g. benefits ), the justification for performing study using an investigational product(s), as well as the expected prophylactic, therapeutic, or diagnostic sign (s). At length, the introductory statement must offer the overall strategy to be followed in assessing the investigational item.

7.3.4 Physical, Chemical, and Pharmaceutical Properties and Formulation

A description ought to be given of this investigational product material (s) (such as the compound or structural formulation (e), plus a succinct summary ought to be due to the applicable physical, chemical, and pharmaceutical properties. To allow proper security measures to be obtained in the duration of this trial, an outline of the formula (s) to be utilized, such as excipients, ought to be supplied and justified when clinically applicable. Directions to the storage and management of this dose form(s) must also be granted. Any similarities with other substances should be noted.

ICH GCP E6 R2
On Mar 8, 2018, the FDA updated ICH E6(R1) with E6(R2) Good Clinical Practice: Integrated Addendum

to ICH E6(R1). Here are some noticeable changes and how they will impact the industry.

1. One of the key improvement is the new definition of a licensed copy of a situation report form (1.11). This improved definition states:"[a] newspaper or digital copy of the first document that's been confirmed (e.g., with a dated signature) or was generated via a validated procedure to make an specific copy using all the very exact features and data as the first." This improvement helps better explain how to ascertain the validity of trial-related documents duplicates, such as source files.

Additionally, the definition of tracking (1.38) has been broadened to incorporate the observation program, which can be described as "[an] outline of these methods, duties, and demands for tracking the trial." The updated definition doesn't call for the monitoring plan for a standalone file, but leaves an expectation that a proper plan is different. In addition, the observation report (1.39) definition has expanded to add "[results] of almost virtually any centralized monitoring also needs to be noted." Nonetheless many patrons now include concentrated monitoring as part of the general monitoring procedures because if this monitoring doesn't happen through a formal onsite observation trip, it might not be satisfactorily documented. The expanded definition will guarantee that patrons produce an account to demonstrate the concentrated monitoring that has been performed.

A number of improvements have been suggested to the Investigator department (part 4). for one, part 4.2.6 has been updated to say:"[in] the event the investigator/institution keeps the assistance of any party to do research jobs, they ought to ensure this celebration is qualified to execute these research jobs and should employ procedures to guarantee the integrity of their analysis jobs completed and any information created." These qualifications and oversight responsibilities weren't explicitly mentioned in the preceding edition, however, clinical trial sponsors anticipated researchers to implicitly stick to those guidelines. The upgraded statements today represent FDA's well- established advice on the pupil's supervisory responsibilities.

The definition of sudden adverse drug response (1.60) currently contains a brand new definition titled "identification of automatic systems" (1.60.1). But, there doesn't appear to be an evident connection between the definition of adverse medication reactions and this definition--"[a] practice of establishing and recording the specified prerequisites of a computerized system may be always fulfilled. An logical step will be to create this new PC validation definition 1.61 then renumber the past two definitions from the Glossary (vulnerable themes and well-being) into 1.62 and 1.63, respectively, and which could possibly be performed when the last record is published.

Part 5.18.6 (Tracking Report) contains a new section (e) that says "[tracking] results should be supplied to the host (such as proper management and personnel accountable for trial and website supervision) in a timely fashion for review and follow up as indicated. Outcomes of monitoring activities must be recorded in enough detail to permit confirmation of compliance with the observation program."

Section 5, Sponsors, comprises substantial adjustments and enhancements. The draft comprised a significant new segment 5.0 (Quality Management), where the notions of quality management, with a focus on risk management, are incorporated into the host's responsibilities. Though risk management procedures are well-known in the healthcare care sector, they have yet to be extensively applied to the preparation and execution of clinical trials. The upgrade will call for clinical trials patrons to start obtaining the essential instruction and tools to establish those principles. Two helpful overall resources include ICH Q9, Quality Risk Management, that will be a high level summary of risk management fundamentals, along with ISO 14971, Application of Risk Management to Medical Devices, a worldwide security standard related to all phases in the life span of a medical apparatus, for example its early growth. While these two records are tailored toward producing hazard management, they can provide useful information related to clinical trial preparation too. Table 1 lists the entire text of this suggested quality control department.

The draft creates no suggested modifications to the Department 3, Institutional Overview Board/Independent Ethics Committee.

In section 4.9, Records and Reports, a fresh introductory announcement (4.9.0) was added which says "[the] investigator must keep accurate and adequate source records and trial documents which have all applicable observations on each of the website's trial topics. Source data ought to be conducive, legible, contemporaneous, first, authentic, and complete. Changes to supply data ought to be traceable, shouldn't obscure the original entrance, and ought to be clarified if required (e.g., through an audit trail)."

Regular review of data that is submitted. Identification of lost information, conflicting data, information outliers, or sudden deficiency of variability and protocol deviations which could possibly be indicative of significant or systematic mistakes in data collection and reporting in a website or through sites, or might be indicative of possible data manipulation or data integrity issues. Utilization of statistical investigations to identify information trends like the consistency and range of information within and across websites. Evaluation of website features and performance metrics. Choice of websites and/or procedures are targeted onsite monitoring.

The previous modification increases section 8.1 (Introduction) the following improvements:"[the] host and investigator/institution need to keep a listing of the place(s) of the individual key documents.’ The storage method (no matter the media used) need to supply for record identification, research, and recovery. Based upon the actions being completed, individual trials will call for additional files not particularly mentioned in the vital document listing. The host or investigator/institution should incorporate these within this trial master document. The host should make sure that the investigator has command of continuous access to the CRF information reported to the host. The host shouldn't have management of these data. When a backup is utilized to replace a first record, the backup should meet the prerequisites for certified copies.

The draft includes several alterations that address fluctuations from the scale, sophistication, and expense of clinical trials because the former version was embraced. Since clinical research workers have access to innovative technologies and risk management procedures that might raise efficacy and concentrate on important clinical research actions, E6 has been amended to promote the implementation of advanced and more effective methods to clinical trial design, conduct, supervision, documenting, and reporting, while still ensuring human subject security and information integrity are preserved. Additionally, the upgrade includes changes to describe criteria on electronic documents and documents that are essential. In the end, the new record is intended to assist clinical research protect human areas, keep data integrity and quality, and correctly record trial benefits. This guide will emphasize the vital changes that impact research professionals. These alterations are anticipated to be assessed and approved inside ICH and then integrated into the E6 record from the end of 2016.

Revisions to the segment on tracking (5.18) reflect a stronger dependence on risk-based observation. The revisions include the components in the FDA's recent advice on risk-based observation. These alterations have been noted in part 5.18.3 (Extent and Nature of Monitoring) and comprise these improvements:"The host must create a systematic, guaranteed, risk-based method of tracking clinical trials. The flexibility at the scope and character of monitoring described in this section is meant to enable diverse approaches that enhance the efficacy and efficiency of observation. A combo of onsite and concentrated monitoring actions could be proper. The sponsor must file the rationale behind the selected observation approach (e.g., from the monitoring program )."

Part 5.20 (Noncompliance) comes with an augmentation which reflects regulatory ability expectations which patrons will try to recognize the root of non-compliance at a strong way and execute effective corrective and preventative strategies. The new segment (5.20.1) says:"[when] important noncompliance is found, the host must execute a root cause investigation and execute appropriate corrective and preventative actions. When required by law or regulation, then the host must notify the regulatory authority(ies) whenever the noncompliance is a severe violation of the trial procedure or GCP."

The draft also suggested a new segment 5.18.7 (Monitoring Plan) that says:"The host must develop a monitoring program that's tailored to the particular human subject security and information integrity risks of this trial. The program must describe the monitoring approach, the monitoring responsibilities of all of the parties involved, the a variety of tracking methods to be utilized, and the justification for their usage. The program should also highlight the observation of essential data and procedures. Particular care ought to be given to all these aspects which aren't regular clinical practice which need further training. The monitoring program should reference the related policies and processes."

Section 5.2, Contract Research Organization (CRO)also comprises two suggested changes that need sponsors to have a more active part in tackling their CROs. Section 5.2.1 was improved with the following announcement:"[the] host must ensure oversight of almost any trial-related responsibilities and works performed on its own behalf." Section 5.2.2 was improved with the following announcement:"[the] host must record approval of some subcontracting of all trial-related responsibilities and works with a CRO." This is very related to small and startup manufacturers which rely heavily upon CROs for handling all or most trial-related pursuits. The modifications state that patrons might not abdicate this duty and have to have a more active part in their supervision of the CROs.

Additionally, the ICH Upgrades underline the usage of centralized tracking as a vital approach to match and lower the frequency or extent of onsite observation.

Section 5.5.3 (b) is modified to describe expectations for normal operating procedures (SOPs) for digital data systems and handling. The proposed language says"[the] SOPs must pay for system installation, setup, and usage. The SOPs must explain system identification and performance testing, information collection and handling, program maintenance and system safety measures, shift management, information backup, recovery, contingency planning, and decommissioning. The obligations of the sponsor, employee, as well as other parties connected to the usage of those unmanned systems ought to be apparent, and the consumers must be supplied with instruction in the usage of their systems." The draft also comes with a brand new announcement 5.5.3 (h), which says that patrons are predicted to"[ensure] that the integrity of their information containing any information that explain the context, content, and arrangement of their information." This inclusion is very important whenever making modifications to the automatic systems, including software upgrades or migration of information.

Clinical research coordinators are usually supervised by clinical research managers. Their main task is to administer the clinical trials. Primary responsibilities normally include administering questionnaires, informing the participants about the objectives of the study, collecting data, and managing all the trials. They also have to adhere to all trial standards that have been set and also participate in recruitment of the subjects. Clinical research coordinators also have to engage with the subjects so that they can explain the things that are expected during the trial and also find out if they have any concerns. This means that a clinical research coordinator needs communicative and interpersonal skills.

For those interested in becoming clinical research coordinators, or enhancing their skills in this role, the Clinical Research Coordinator course provides comprehensive training and certification.

The responsibilities:

1. Maintaining records of all studies as per the guidelines.

2. Sticking to all ethical standards.

3. Sticking to all the regulatory standards set, including those covered in the ICH-GCP course.

4. Administering questionnaires.

5. Managing the budget dedicated to the research.

6. Overseeing the running of the trials as smoothly as possible.

7. Understanding and engaging with the subjects so as to know all issues.

8. Making sure that all equipment and supplies that are necessary for the success of the study are working and in stock.

9. Participating in the recruitment efforts of the participants, a topic extensively covered in the Clinical Trials Assistant Training.

10. Working with the laboratories so as to share findings.

Requirements:

The qualifications of a clinical research coordinator usually depend on your locations or employer. In most cases, for you to access clinical research coordinator jobs you should:

• Have an associate nursing degree or any related field

• Experience of two years within the healthcare industry

• Analytical mindset

• Be attentive to detail

• Have interpersonal skills which are exceptional

• Be ready to continue learning even without being prompted to do so, which can be further supported by the Advanced Clinical Research Project Manager Certification.

• Great skills in organizing

• Have great verbal and written communication skills

Additional certifications such as the Pharmacovigilance Certification, CRA, Advanced Principal Investigator Physician Certification, and Medical Monitor Certification are also beneficial for those looking to further their careers in clinical research.