Why Are Clinical Research Seminars Important

The purpose of the clinical research seminars is to impact the attendees with knowledge about important aspects of clinical research, such as the professional ethics, operational aspect and regulations. Education and training are very important in this field and vital to the success of trials. Seminars are another way of training clinical research professionals or other related professionals that have an interest in the field.

Seminars can be held every two weeks, monthly or quarterly. It depends totally on the organizers and what they aim to achieve with the seminar. For example, some organizers may hold a biweekly seminar for young interns to help them improve their knowledge and sharpen their clinical research skills.

Clinical research seminars are ideal for the following sets of people:

• Clinical research coordinators

• Project managers

• Nurses

• Clinical research associates (CRAs)

• Regulatory experts

Other staff also involved in clinical research can as well attend the seminar to improve their knowledge. Common topics that are discussed at the seminars include :

• Good Clinical Practice (GCP)

• Professional ethics of clinical researchers.

• Auditing clinical trials

• Advanced quality monitoring

• Monitoring oncology trials

• Current regulations

• Inspection preparation

• Resources involved with clinical research.

• Guidelines pertaining to clinical research.

These seminars are usually handled by experts and professionals in the clinical research industry. They are usually have worked with different leading pharmaceutical companies biotechnological companies, device companies, and leading academic institutions.

Clinical research seminars can also provide extra benefits. This depends a lot on who the organizers are, but some clinical research seminars provide those in attendance with SOCRA (Society of Clinical Research Associates), ACRP (Association of Clinical Research Professionals) and CME Continuing Education Credit hours.

Apart from seminars organized by different institutions that an individual can apply for, seminars can also be organized for in-house training. They can be tailored to meet your company's specific needs. Organizers can provide your company with a set of training options that range from single topic seminar presentation to more comprehensive programs. For instance, some organizers make use of different hands on approach by providing activities and simulated case studies to help the audience's learning process.

As an individual you can register yourself to become a participant of upcoming clinical research seminars at ccrps.org. As an organization or company as well, you can register your staffs for these seminars. As a company, you can register for in-house training, where the seminars can be tailored for your specific needs.

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

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Free Online Clinical Research Courses

Clinical research plays a very vital role in medical health care. Before anything is put into practice, it will have to be discovered first and tested: this is the role of clinical research.

Free online courses on clinical research teach the basics of clinical research. They help students understand more about modern health care and the role of clinical research and its discovery. Courses like these are ideal for college students and people who are considering taking up a career in health care and life sciences. It is also good for social care practitioners that want to find out more information about the role of clinical research in improving the quality of healthcare.

Clinical research training for research professionals include taking necessary courses and getting the necessary accompanying certification. However, clinical research professionals can also take part in courses teaching the rudiments of clinical research and good clinical practice. An example of one of such courses is the one offered by National Institutes of Health (NIH). The course "Introduction to the principles and practice of clinical research" is a course that teaches professionals how to improve their effectiveness and to as well safety. This course covers topics like study design, monitoring and regulatory considerations, how to prepare and implement clinical studies, statistics, ethical and legal considerations in clinical research, measurements, additional study design etc. A course like this helps you to understand the very basics of clinical research and improves your efficiency.

As good as free online clinical research courses are to help you develop your career as a clinical research professional, they are not meant to take the place of the required training needed, especially those that train you in the protection of the human subjects of clinical research. For those interested in specializing further, consider the Advanced Clinical Research Project Manager Certification or the Advanced Principal Investigator Physician Certification.

For further details and information on how to get free online courses for clinical research professionals, visit ccrps.org. Whether you are a research professional looking to learn more and better your career or you are a student or someone just taking up an interest in the field of clinical research, there will be something for you.

Take courses from CCRPS and learn more on how to become a clinical research professional, such as the Clinical Research Coordinator, Pharmacovigilance Certification, CRA, ICH-GCP, Clinical Trials Assistant Training, or Medical Monitor Certification.

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Online Clinical Research Assoicate (CRA) Training

Clinical research associate training is the grooming of clinical researchers to become associates. It's a promising career in the clinical research industry. Any worth-while training will include everything you need to know to about the job and become one of the best.

Clinical Research Associates are those responsible for the planning, setting up, and coordinating clinical trials. They provide technical assistance for experiments, make sure that the scientists that are involved in the clinical research trials comply with regulatory standards, and also collect results during the clinical trials. When the trials are over they are also to be involved in the presentation of the results to the public in a manner that is useful and understandable. Enhance your skills as a Clinical Research Associate with CRA training.

The amazing part about being a clinical research associate is that jobs are available in both the laboratory and office setting.

To be an associate in clinical research you need a minimum degree of a bachelor's or master's degree in the clinical research field of study or a related field. They have the key responsibilities of designing and implementing clinical research trials, to train staff, to monitor progress, to screen test subjects, to present findings, and to help maintain the database of all clinical research trainees.

The median salary of a clinical research associate boasts of $61,932 annually. It is one of the most attractive salaries for someone with a science degree, as it is always on a rise and there is always a ready market for clinical research professionals.

A clinical trial is a method in which new medical treatments and pharmaceuticals are developed and experimented and this is where clinical research associates come in. They are an integral part of the process, as they work with teams to design, implement, and organize research trials to test out the effectiveness of the proposed medicines on humans. They are responsible for the different parts of clinical trials which include, training of staff, screening test subjects, monitoring the progress of staff, present findings, and maintain the database. Communication skills, science knowledge, and a strong mathematics knowledge base are the core skills you need in the clinical research profession. For those interested in more specialized roles, consider the Advanced Clinical Research Project Manager Certification or the Advanced Principal Investigator Physician Certification.

You can come from a variety of medical sciences or health-related fields, such as a nursing background as an RN. Courses offered expand on clinical related ethics, team management, and research methodologies.

CRA training certificate examination comes with one of the three combinations of education and experience.

• High school diploma and 6,000 hours of experience.

• An associate degree in clinical research fields and 4,500 hours of experience, or

• A Bachelor's, Master's, or Registered Nurse degree and 3,000 hours of clinical research experience.

Get a clinical research associate certificate from certified clinical research professionals course, and earn your way to one of the most lucrative fields in clinical research. At CCRPS, we support online learning, so you can take the classroom everywhere. Learn more about Clinical Research Coordinator training and Pharmacovigilance Certification to broaden your expertise.

Take courses from CCRPS and learn more on how to become a clinical research professional. Further your understanding of good clinical practices with the ICH-GCP course.

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Clinical Research Coordinator Certification

Clinical research coordinator (CRC) play an integral role in all kinds of medical studies. Working under the direction of the principal investigator, who designs, conducts, and manages clinical trial; the clinical research coordinator supports, organizes, and facilitates the daily activities of the clinical trial.

A Clinical research coordinator manages, oversees, executes tasks and day to day clinical trial activities. They also work in conjunction with sponsors, departments, and institutions to manage finances, obtain compliance, and work through personal issues.

Their responsibilities include the planning and management of the following initiatives:

• study

• enrollment

• maintenance

• training

• compliance with institutional, state, and federal regulations

CRCs engage directly with the trial participants, screening them for eligibility. They also help develop and implement recruitment strategies and work with all the available teams during the trial period.

In the lab, CRCs carry our experiments, medical studies, and clinical researches. A CRC works closely with labs, medical centers, and research hospitals to evaluate research protocols and seek approval from regulatory committees.

To get certified as a CRC, you must have either:

• A bachelor's or higher degree in health sciences in clinical research administration and submission of a fully detailed resume that documents at least 3,000 hours of performed designated duties

• A Registered Nurse (RN), LVN, Licensed Practical Nurse (LPN), or an associate degree and a submission of a detailed report that documents at least 4,500 hours of performed designated duties.

• Worked as a laboratory technician, medical assistant, or a high school diploma and submission of a detailed report that documents at least 6,000 hours of performed designated duties.

For those with a bachelor’s, a degree in medical technology, public health administration, or microbiology, with an additional two years master's degree in management positions (optional) is ideals. Human anatomy, biostatistics, epidemiology, health care management, biochemistry, and mathematics, are the courses typically required for these majors.

Management and communications experience coupled with interpersonal and multitasking skills are essential job skills to possess. Internships and/or low entry-level jobs as health care workers or lab technicians should also be considered to get familiarized with the working environment. It is important to note that there may be a substitution for hours of qualifying work experience.

After qualifying, you need to pass an exam and get certified. A CRC certification lets you practice legally and can see you earning from as little as $48,000 to as much as $60,000 annually.

To learn more, take a course in clinical research coordination to help develop and refine your skills before you go on to get the clinical research coordinator certification.

Discover more from Clinical Research Training | Certified Clinical Research Professionals Course. Other recommended courses for aspiring professionals include:

• Pharmacovigilance Certification

• CRA Certification

• Clinical Trials Assistant Training

• Advanced Clinical Research Project Manager Certification

• Advanced Principal Investigator Physician Certification

• Medical Monitor Certification

These courses provide essential knowledge and training for those interested in advancing their careers in clinical research.

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

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What is the Benefit of a Master's in Clinical Research

A Master's in Clinical Research opens up a wide range of job options. There's a huge market for clinical professionals with experience and expertise in the developing, conducting, and monitoring processes in clinical trials to help transform scientific discoveries and research into possible and usable treatments.

It's a dynamic, high demand profession that fits all lovers of science. Getting a Master's in Clinical Research gives you the skills to develop, conduct, coordinate and monitor clinical studies. It also helps you comply with the protocols of regulatory agencies.

A Master's in Clinical Research can take you to more financially rewarding clinical research career choices and opportunities. It can also set you up to work at a variety of companies, like public and private medical institutions and companies, contract research organizations, hospital systems. Once you are in the field, there is an enormous amount of position choices. Additionally, you can expect a steady promotion to industrial, research, managerial, supervisory or specialist positions.

The minimum requirements you need for your Master's in Clinical Research are either a bachelor's degree in medical sciences, an advanced education in health professions with work experience, or a standardized test score like GREs.

Clinical research masters online will include a combination of the following;

• Regulatory and compliance issues

• Biostatistics and computing

• Epidemiology

• Clinical research trials designing

• Medical informatics

• Health services research

• Supervised clinical research

• Concentration in research management

• Patient-oriented research

• Experiential learning in clinical research

• Clinical trial management

• Concentration in investigation

• Regulatory affairs

• Conducting clinical research studies

• Health care

• Biologics

• Health sciences policies

• And others

A Master's in Clinical research is a 30 - 33 credit program, depending on the course you want. It is comprised of required courses, program electives, course works, cognate electives, thesis or project, and supervised research. There's a wide range of specialized clinical research masters to go for: clinical research professional, clinical research administration, clinical research coordinator, and others. As an area of medical sciences that is growing tremendously. Demand is so high that the median salary is $82,090 and varies depending on the geographical location and work experience. You can check positions and salaries near you here.

To learn more about the courses offered and how the Master's in Clinical Research program is run, check out this clinical research master's degree program.

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

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Top 4 Clinical Research Books You Need To Read

With scientific discoveries and technological advancements comes knowledge. This knowledge defines the scope and practices of the different fields of professions that they apply to. Due to the continuous nature of medical research, the medical sciences are not also behind on scientific discoveries. More often than not, there is a new field knowledge that changes the way people do their job. The change could be something in something routine as checking the blood pressure of a patient or measuring the body temperature. A smart clinical research scientist knows that they have to ensure that they stay up to date with scientific discoveries to help patients as well as themselves.

If you have been offered a clinical research job or you are interested in one, one thing you should know for sure is that to be successful in this field, you need to know your stuff. It is true what they say, to remain relevant in any field is to remain knowledgeable.

To help your cause, we have made a list of 6 books that will help you succeed in the clinical research field.

• Fundamentals of Clinical Trials, by Lawrence M. Friedman, Curt D. Furberg, David DeMets. This book looks into key issues like assessment, reporting of results, randomization, interpretation etc. This book introduces clinical trials to you beautifully, with real life examples used to explain key features of clinical trial.

• Designing Clinical Research, by Dr. Stephen B Hulley, MD, MPH, Steven R Cummings, MD, Warren S Browner, MD. This book is an important book for doctors, pharmacists, nurses and all medical professionals involved in medical research. It explains useful methods for designing, funding and implementing clinical research.

• Publishing and Presenting Clinical Research, Third Edition, by Warren S. Browner MD. This book contains the essentials of clinical trials and publication. This book will come in handy for those who wants to know more about organizing, delivering, and publishing the results of their research in the best way possible.

• Practical Guide to Clinical Data Management, Third Edition, by Susanne Prokscha. One issue that always pops up in clinical research is how to manage the large volumes of ever increasing data. If you are already working in the field, you could no doubt relate. This is a task that can be rightfully described as “extremely time consuming”. This book gives powerful insights on current industry tactics on the use of Electronic Data Capture (EDC) for clinical research. This book will help you solve the age-long problem of managing voluminous clinical research data.

Honorable mentions

• Basic Principles of Clinical Research and Methodology by S. K. Gupta

• A Clinical Trial Manual from the Duke Clinical Research Institute. Kate Davis, Margaret Liu.

• Handbook for Good Clinical Research Practice. WHO.

We have introduced many good reads for those who like to stay informed. Whether you are someone looking to get started in the field or someone who is looking for a refresher, these are the perfect places to start. If you need motivation to get reading, here are some clinical research positions to remind you of what is possible when you apply yourself.

If you prefer online classes with professional guidance, check out CCRPS’ certification courses. They offer one of the only major ACCRE accredited courses in the US. The courses are created by real, senior professionals who skip the nonsense and get right into what you need to succeed in the field.

To learn more about the role of a Clinical Research Coordinator, consider this Clinical Research Coordinator course.

• Explore the realm of drug safety with our Pharmacovigilance Certification.

• Dive into clinical research specifics with the CRA certification.

• Understand the essential regulations with the ICH-GCP course.

• Begin your journey in clinical trials with the Clinical Trials Assistant Training.

• Enhance your skills with the Advanced Clinical Research Project Manager Certification.

• For physicians aiming at leading research, consider the Advanced Principal Investigator Physician Certification.

• Specialize in monitoring clinical trials with the Medical Monitor Certification.

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

How Does Clinical Research Billing Work?

Clinical research billing is a very important part of medical research, but it is a little bit complex because there are usually more than one person involved or responsible for the bill or cost of a research.

There are three ways the billing of a clinical research can play out:

• When the procedures and services of a clinical research is solely for study purpose, the bill is generally cleared by the research sponsor. Those interested in managing such responsibilities can benefit from our Clinical Research Coordinator course.

• When the procedures and services of the research is considered to be a standard of health care or routine treatment and would have been administered to the subject even if there was no research. In this case, the bill is generally on the subject or the subject's insurer but the sponsor can be involved in the payment depending on contractual agreement. To understand the pharmacological safety aspects involved, consider our Pharmacovigilance Certification.

• There are those that are a mixture of both. Procedures that are standard treatment billed on the subject and their insurer and procedures that are solely for research purposes billed on the research sponsor. To learn more about handling these scenarios, check out the Advanced Clinical Research Project Manager Certification.

Depending on contractual agreement between the research sponsor and the subject of the research, treatment of adverse effects of the study might be paid for by either the sponsor or the subject (and their insurer). Those interested in managing clinical trial processes may find the CRA course useful.

Due to the number of parties involved in the billing process, there could be some miscommunication and it could lead to billing errors. It is important to note that the clinical research centres have financial regulations to comply with, like the clinical research billing compliance. They guard against financial issues that may occur like double billing. Our ICH-GCP course can provide insights into these essential guidelines.

For instance, if a research has already been paid for by the sponsor, it must be communicated to the clinical research institute so that they don't bill the subject (patient) or their insurer. If the subject is billed for a research paid for by the sponsor, that is called double billing and an obvious transgression against clinical research billing compliance.

The exception is in cases where there's a legal contractual agreement for both parties to be responsible for the payment. This is possible in a situation like the third scenario above, where there is a mix of procedures for standard treatment and procedures for research purposes. The sponsors can clear the bill for the procedures that are solely for research purposes while the subject and their insurer is billed for the procedures that are standard treatment. Communication between concerned parties is key in clinical research billing.

Another common compliance risk is to charge a subject for a procedure that was promised as free in the research informed consent form. Every promise made to the subject in the form must be kept. Enhance your skills in this area with our Medical Monitor Certification.

To learn more, you can take a course in clinical research billing compliance. This will help develop your knowledge and skill in maintaining compliance and other practices involved with clinical research billing.

For those looking to specialize further, consider the Advanced Principal Investigator Physician Certification or begin your journey with our Clinical Trials Assistant Training.

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

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CRA Exam Questions

$40,000If an agency requires 20% cost sharing of the total project for a particular program and a proposal is requesting $200,000 from agency, what is the additional amount that the institution must cost share?2.$50,000An investigator on a NIH grant has permission to rebudget $50,000 in supply monies into equipment. If the Institution's facilities and administrative cost (indirect cost) rate (based on MTDC) is 50% how much money will be available for the equipment3.$100,000An anti-lobbying certification is required on federal grants, cooperative agreements, and contracts exceeding a MINIMUM of4.$165,000An institution has an indirect cost rate of 40%. A research project is budgeted at $125,000 in direct costs including an item of equipment at $25,000 which is the only item excluded from the indirect cost base. What is the total cost for the project?5.1.Publicly known information.2. Already known information.3. Information received from others. 4. Information shared with others. 5. Independently developed information. 6. Information not included in the nondisclosure agreement.What is not included in a Nondisclosure Agreement?6.1) Resubmit 2)Appeal 3)Advice to look for other opportunitiesWhat happens to a proposal if it isn't funded?7.2NIH limits how many resubmissions on proposals?8.2 CFR 215 OMB A-110Administration Regulation for Education Institutes, Hospitals, and Non profits9.2 CFR 220, OMB Circular A-21Deals with cost determination but does not identify the circumstance or dictate the participation in the financing of a project

10.2 CFR 225 OMB A-87Cost Principles for State, Local, and Indian Tribal11.2 CRF 215 (OMB Circular A-110) provides regulations governing which of the following for educational institutions?
a. Administrative requirements for contracts
b. Administrative requirements for grants and cooperate agreements
c. Cost principles for grants and cooperative agreements only
d. Administrative requirements and cost principles for grants and cooperative agreementsb. Administrative requirements for grants and cooperate agreements12.3 years from submission of final report of expendituresRecipients of federal grant funds must retain records for a MINIMUM of13.5 membersAn IRB is required to have at least:14.6-9 monthsThe National Science Foundation indicates decisions on the funding of grant proposals should normally take15.26%The administrative cap on federal negotiated F&A rates is equal to16.90Under Expanded Authority, pre-award costs up to _____ days prior to the effective date of the award the PI can accrue charges before the award start date.17.90 daysIf final financial reporting (FS 425 Report) to federal agencies is not completed with in the typical ___ days, the institution is out of compliance18.90 daysWhen granted expanded authorities, pre-award costs on a federal grant may be incurred by an institution within a MAXIMUM of how many days prior to the official start date?19.90 daysHow many days do recipients of federal grants funds have to submits final reports after completion of the project?

20.A-102State and local governments are subject to which of the following OMB Circulars?21.AbstractShould be 5,000 to 25,000 words in length. This summary should demonstrate to the reader the most important parts of each of the sections of the research proposal in around 200 words.22.Accept, Decline or NegotiateWhen an award is made an institution has the following options.23.Access to federally funded research data is required under the:
a. Solomon Act
b. Davis-Bacon Act
c. Shelby Amendment
d. Stevens Amendmentc. Shelby Amendment24.According to federal regulations, which of the following must be included in an Institution Review Board?
a. Ethicist
b. Attorney
c. Member of the clergy
d. Member unaffiliated with the institutiond. Member unaffiliated with the institution25.Acquisition of property or servicesA procurement contract is used for the purpose of26.Administrative requirements for grants and cooperative agreements only2 CFR 215, OMB Circular A-110 provides regulations governing which of the following for educational institutions?27.AdobeWhat is required to use Grants.gov28.advise student to apply to the federal agency to request a proposal 90 days after proposal was submittedIf a graduate student comes into a university sponsored research office claiming that because of the federal Freedom of Information Act (FOIA) he has the right to obtain a copy of a recently submitted proposal, the research administrator should

29.Allocable costA cost that can be assigned to a project or an activity based on the relative benefits received30.allowable only if approved by the sponsoring agencyAccording to OMB Circular A-21, costs incurred prior to the project start date are:31.All vertebrate animalsThe Federal Animal Welfare Act applies to which of the following animal species32.AnnuallyIf an institution of higher education is subject to OMB Circular A-133, when must it have an independent audit?33.The Anti-Kickback Act of 1986Which of the following aims at deterring subcontractors from making payments and contractors from accepting payments for the purpose of improperly obtaining or rewarding favorable treatment in connection with a prime contract or a subcontract relating to a prime contract?34.An anti-lobbying certification is required on federal grants, cooperative agreements and contracts exceeding a MINIMUM of:
a. $100,000
b. $500,000
c. $1,000,000
d. 10,000,000a. $100,00035.approval of student's embassyIn order for a foreign national doctoral student researcher to work on a federal grant in an American institution, it is necessary for the student to have36.Assure that the highest quality proposals are selected for funding in an equitable mannerWhich of the following is the primary purpose of federal proposal review processes?37.An award similar to a grant, and anticipates having substantial involvement in research activities once the award has been made.What is cooperative agreement?38.Award terms and conditionsA Notice of Award typically includes which of the following

39.Basic and containment procedures designed to protect personnel and the environmentWhich of the following best describes essential laboratory biosafety levels in medical research?40.Bayh-Dole ActWhich of the following was enacted as a uniform patent policy among the many federal agencies that fund research?41.BequestsA type of donation or gift with few or no conditions specified. Gifts may be provided to establish an endowment or to provide direct support for existing programs.42.Break refreshments at a project sponsored workshopUsing the criteria contained in 2 CFR 220, OMB Circular A-21, which of the following costs would most likely be allowable as a direct expenditure item on a federal grant?43.Budget period is yearly. Project period is the life of the contract.What's the difference between budget period and project period?44.a cabinet-level departmentThe Office for Human Research Protection is administered by45.A career development programAn employee in a position which does not enable realization of full potential would benefit most from46.cash flow statementAn important tool you may use to measure and track the flow of
cash into and out of your operation47.Certifications and representationsJust-In-Time initiatives postpone the submission of which of the following items until a decision to make an award is reached?48.Change in allocation within a single budget categoryWhich of the following changes does not require prior National Science Foundation approval?49.Change OrderA written order signed by the contracting officer, directing the contractor to make changes that the changes clause of the contract authorizes the contracting officer to order without the consent of the contractor.50.Chief Executive Officer or Vice President of ResearchWho appoints the chair for each committees at universities

51.A citation of the contract clause authorizing the terminationWhich of the following information must be included in the notification by a federal officer to the contractor to terminate a contract for convenience52.Clinical trial AgreementWhich of the Following types of documents is most appropriate for testing the efficacy and safety of a new drug, device, or vaccine?53.Code of Federal RegulationsThe following provides information on patent rights and responsibilities currently applicable to universities and federally sponsored projects54.cognizant agencyA Federal agency responsible for negotiating and approving facilities and administrative cost rate for an education institution on behalf of all other federal agencies is referred to as the55.Commons Business DailyWhich of the following sources is not commonly used for federal funding opportunities?56.Compliance approvalsRetention of which records are required by the OMB57.Contact legal, then contact program officer over concernsIf a PI received an award and his wife is using the lab and charging to the award. How would you handle it?58.The contractor fails to perform the services within the time specified or any extensionWhich of the following is a reason for a federal contracting officer to send a "Show Cause" notice to a contractor?59.Contract Work Hours and Safety Standards ActThis act would require that certain contracts contain a clause specifying that no laborer or mechanic doing any part of the work contemplated by the contract would be required or permitted to work more than a certain number of hours in any workweek60.control commodities and is governed by Department of CommerceIn Export Control, what does Export Administration Regulation control and who governs it61.control money: Governed by Department of Treasury.In Export Control, what does Office of Foreign Assets Control control and who governs it

62.Cooperative Research And Technology Enhancement Act hopes to enhance research among Universities, private and public sectors, by treating joint inventions as if they are a single owner but only if the collaborators sign an agreement prior to the invention being created.What is the CREATE Act?63.CopyrightIn which of the following areas of intellectual property is the concept of work-for-hire germane64.Cost Accounting StandardsIt is the ___________ that dictate the way in which a contractor must maintain its accounting system.65.Cost Accounting Standards (CAS) must be applied to awards:
a. without federal funding
b. received from any funding source
c. for federal contracts over $500,000
c. for all federal awards covered by 2 CFR 230 (OMB Circular A-122)c. for federal contracts over $500,00066.Cost of Living Allowance COLAgranted to employees based in a foreign city, where cost of living is higher than in Washington, D.C.67.Cost Principals for Educational InstitutesWho is the 2 CRF 220, OMB Circular A-21 for68.A cost reimbursement sub agreementRequires that the subrecipient use best efforts to complete the research

69.Cost sharing must be:
a. verifiable from records
b. included with other federal awards
c. paid from federal funds if it is a fellowship
d. donated third party contributionsa. verifiable from records70.cost sharing occurs when the sponsored program requires financial support for the project from the awarded institution as a condition of the award.What is involuntary committed (mandatory) cost sharing?71.Data Management Plan RequirementNo more than 2 pages and must describe how the proposal will conform to NSF policy on dissemination and sharing of research results.72.Data sharing plan/ Publish and ShareApplicant who are planning to share data may wish to describe briefly the expected scheduled for data sharing, the format of the final data set, the documentation to be provided, whether or not any analytic tools also will be provided and so on ...73.Debarment and suspension rulesWhich of the following is included in 2 CFR 215, OMB Circular A-110?74.Default and convenienceTwo critical termination clauses of the General Provisions of a federal contract75.Department of AgricultureWhich agencies is responsible for administering the Animal Welfare Act?76.Department of EnergyWhich of the following agencies does NOT fund health science research77.Director of Human ResourceWho should administer progressive discipline to an employee?78.the Director of the institution's animal careAs required an IACUC Committee must contain all but one of the following a. a Doctor or Veterinary Medicine, b. a practicing scientist experienced in research with animals, c. the Director of the institution's animal care facility, d. a person not affiliated with the institution79.Each calendar yearOMB Circular A-21, time and effort reporting must be submitted to the institution a MINIMUM of once

80.Each organization using animals in Public Health Service projects must provide written assurance of its compliance with:
a. regulations requiring full-time staff veterinarian
b. provisions for an organizational program for the care and use of animals
c. standard for accreditation with the American Association for Accreditation of Laboratory Animal Care
d. requirements for organizational training and instruction program in the human practices of animal care and used. requirements for organizational training and d. requirements for organizational training and instruction program in the human practices of animal care and use81.Efficient and effective operations and reliable financial reporting are the objectives of:
a. internal controls
b. research compliance
c. cost transfer processes
d. postaward administrationa. internal controls82.electronic funds transferThe federal government prefers to disburse funds under federal grants via83.enacted to assure that a fair portion of federal contracts are placed with small businesses.What is the Small Business Act?84.Equipment donated at fair market valueIs allowable as cost sharing85.Established fundamental national policy for the environment and established the council on environmental qualityWhat is the National Environmental Policy Act?86.Evaluation PlanIt is important to define carefully and exactly how success will be determined.

87.E-VerifyFAR 52.222-54, which requires that federal contractors or subcontractor verify the employment eligibility of all new hires on a contract through an electronic screening database.88.Every 3 yearsHow often do approved animal protocols need to be reviewed by the Institutional Animal Care and Use Committee (IACUC)89.Executive Branchbranch of the government is responsible for enforcing the laws of the land. The president, vice president, department heads (cabinet members), and heads of independent agencies carry out this mission.90.Executive Level II $181,500NIH Salary cap is at what percentage?91.Executive Level I, II, IIIWhat is the highest level of salary?92.Executive Orders 8248 and 11541Establishing the divisions of the Executive Office of the President and defining their functions and duties
Source and -Prescribing the duties of the Office of Management and Budget and the Domestic Council in the Executive Office of the President93.Expanded AuthoritiesDelegates to grantees authorization of one year, no cost extension94.Expanded Authority_____waives certain prior approval requirements by a federal sponsoring agency. It is used only for changes that are necessary for the completion of the project within its original scope and original total budget.95.FabricationMaking up data or results and recording or reporting them96.A facilities & administrative costs (indirect cots) rate is usually established based on:
a. prior actual costs
b. reimbursed costs
c. capital expenses
d. unaudited expensesa. prior actual costs

97.A facilities and administrative cost (indirect cost) may be a direct cost if:
a. it meets the definition of allocable
b. "unlike circumstances" are present
c. normally allowable on federal or federal flow-through awards
d. the award activities are like those generally charged as facilities and administrative costs (indirect costs)b. "unlike circumstances are present98.Faculty have share in the companyConflict of interest may exist when medical faculty members conduct drug clinical tests for a company if99.A faculty member has a 5-yar federal NIH grant which will terminate 8/31, with $14,000 remaining on 7/15 of the same year. A competing continuation was recommended for approval but not funded. Which of the following is the most appropriate advise for the research administrator to give to the member
a. buy as much equipment as possible before the grant year ends
b. request a second review of the continuation application for the NIH
c. transfer laboratory personnel salaries to the to use up the remaining funds
d. request a 1-year, no-cost extension of the grant while revised continuation is under preparationd. request a 1-year, no-cost extension of the grant while revised continuation is under preparation100.F&A is not allowed to be charged on the following?Participant support*, equipment, capital equipment, patient care, tuition, building renovations, rental costs for non-University owned space, scholarships/fellowships, Subawards in excess of $25,000. 
*NSF only

101.FalsificationManipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record102.FARIn order for a contractor to be awarded a federal contract, he must comply with the provisions set forth by:103.FARThe overall guiding principle of __________ is to have an acquisition system that can satisfy customer's needs yet minimize administrative overhead without sacrificing integrity, fairness, openness and public policy objectives.104.A federal agency responsible for negotiating and approving facilities and administrative cost (indirect costs) rates for an educational on behalf of all other federal agencies in referred to as the:
a. lead agency
b. cognizant agency
c. sponsoring agency
d. governmental agencyb. cognizant agency105.Federal commonsWhat is an Internet grants management portal which serves the grantee organization community?106.Federal expanded authorities permit which of the following without additional sponsor approvals?
a. Rebudgeting
b. Change of the Institution
c. Renovation of laboratory space
d. Change of the principal investigatora. Rebudgeting107.Federal Financial Assistance Management Improvement Act 1999 Public Law 106-107The impetus to change the ways in which federal agencies accept grant applications and manage grant awards has

108.The federal government prefers to disburse funds under federal grants via:
a. letters of credit
b. reimbursement check
c. electronic funds transfer
d. advanced treasury checksc. electronic funds transfer109.Federal regulations governing the use of humans in researchAlways require full informed consent of the subject or the subject's guardian110.The first $25,000When a subaward is involved in a federal grant to a large university, on what portion of the subawardee's budget does the prime institution recover facilities and administrative cost(indirect cost)?111.FOA instructions always supersede these form instructions.If you have a funding opportunity announcement (FOA), which instructions do you go by... the research form or the FOA112.For copyrighted works which result from federally sponsored activities the federal government usually requires
a. disclosure of the copyright only
b. one copy of the official archives
c. a royalty-bearing , exclusive, and irrevocable license
d. a royalty-free, nonexclusive, and irrevocable licenseb. one copy of the official archives113.Formulation of the President's Budget;
Action by the Congress; Presentation (to Congress) and-Execution of enacted budget lawsWhat are the 3 main phases in the Federal Budget Process114.Freedom of Information Act (FOI)What act brought this on FFATA?

115.From any institution that receives more than $700,000 in federal fundingUnder which of the following conditions is a Certificate of Current Cost and Pricing required116.The Fulbright Program provides opportunities for
a. teaching abroad
b. service abroad
c. teaching n low income communities
d. construction of low income housinga. teaching abroad117.Goals/Objectives/SOW/ImplementationApplicant should explain the expected results and benefits of each objectives.118.House of Representativesa provision or report language included primarily at the request of a Member, Delegate, Resident Commissioner, or Senator providing, authorizing or recommending a specific amount of discretionary budget authority, credit authority, or other spending authority for a contract, loan, loan guarantee, grant, loan authority, or other expenditure with or to an entity, or targeted to a specific State, locality or Congressional district, other than through a statutory or administrative formula driven or competitive award process.119.How does an institution find their DUNS numberYou can contact your office of sponsored research or you can also log in to the eRA Commons.

120.How many days do recipients of federal grant funds have to submit final reports after completion of the project period?
a. 30 
b. 60
c. 90
d. 120c. 90121.How often do approved animal protocols need to be reviewed by the Institutional Animals Care and Use Committee (IACUC):
a. Annually
b. Semiannually
c. Every 2 years
d. Every 3 yearsd. Every 3 years122.How to do business internationallyThe Office of Commercial and Business Affairs (CBA) plays a major role in coordinating trade and investment matters to support U.S. firms doing business overseas. Our mission is to engage U.S. government resources to assist and promote U.S. business interests overseas, and to ensure that private sector business concerns are fully integrated into U.S. foreign and economic policy.123.iEdisonInteragency Extramural Invention Information Management System helps government grantees and contractors comply with a federal law, the Bayh-Dole Act regulations require that government funded inventions be reported to the federal agency who made the award

124.If a graduate student comes into a university sponsored research office charging that because of the federal Freedom on Information Act (FOIA) he has the right to obtain a copy of recently submitted proposal, the research administrator should
a. provide student with a complete copy of the proposal
b. provide student with a copy of the proposal with proprietary and salary information blacked out
c. advise student to apply to the federal agency to request a proposal 90 days after the proposal was submitted
d. tell the student to wait to apply to the federal agency until after the decision is made on the proposald. tell the student to wait to apply to the federal agency until after the decision is made on the proposal125.If an agency requires 20% cost sharing of the total project for a particular program and a proposal is requesting $200,000 from the agency, what is the additional amount that the institution must cost share?
a. $40,000
b. $50,000
c. $100,000
d. $220,000$50,000
$200000 / .8 = $250,000

$250,000-$200,000 = $50,000126.If an institution of higher education is subject to OMB Circular A-133, when must it have an independent audit?
a. Annually
b. Biennially
c. Triennially
d. At the discretion of its governing bodya. Annually127.If a principal investigator proposes to conduct research involving human subjects who will take a standardized educational test, but the test will not include any names or other identifying information, the proposal should be:
a. reviewed by the full Institutional Review Board
b. submitted for expedited review by the Institutional Review Board
c. submitted for review to the Office of Human Research Protection
d. treated under organization's policy as exempt from reviewb. submitted for expedited review by the Institutional Review Board

128.The impetus to change the ways in which federal agencies accept grant applications and manage grant awards has been mandated by:
a. e-Government strategies
b. new audit policies at the Office of Management & Budget
c. Office of Science & Technology Policy
d. the Federal Financial Assistance Management Improvement Act of 1999 (Public Law 106-107).d. the Federal Financial Assistance Management Improvement Act of 1999 (Public Law 106-107).129.indemnityOne may use what kind of clause to require that one party indemnify the other when certain expenses are incurred130.individual account in an approved accounting systemUpon receipt of awarded projects, educational institutions are required to establish131.Information is made available to the public by publication in the Federal Register, upon request given a description of the records desired and provides an opportunity to read and copy records at convenient locations.What is the Freedom of Information Act?132.In order for a foreign national student researcher to work on a federal grant in an American institution, it is necessary for the student to have:
a. a visa
b. United States citizenship
c. evidence of English proficiency
d. approval of student's embassya. a visa133.The Institutional Animal Care and Use Committee (IACUC) is required to inspect animal facilities a MINIMUM
a. one a month
b. twice a year
c. once a year
d. once every three yearsb. twice a year134.Institutional Biosafety CommitteeWhich of the following is mandated for the oversight of research involving recombinant DNA

135.Institutional National Research Service AwardsThe National Institutes of Health requires a written description of a program for providing instruction in the responsible conduct of research for136.The Institutional Official for a sponsored research projectThe individual authorized by the Board of Trustees to sign on behalf of the institution137.Institutions, InvestigatorsWho is covered by the COI regulation138.Institutions that have more than $25,000,000 in federal grants or contractsWhich of the following would be required to file a disclosure statement (DS-2) with the federal government?139.internal controlsEfficient and effective operations and reliable financial reporting are the objectives of140.International Traffic in Arms Regulations (ITAR) are controlled by the :
a. United Nations
b. U.S. Department of State
c. U.S. Department of Homeland Security
d. Bureau of Alcohol, Tobacco, and Firearmsb. U.S. Department of State141.In the credentials boxWhere do you put the ERA Login?142.In the event of cost overrun by a subcontractor, who would be held responsible by the funding sources?
a. Subcontractor only
b. Prime contractor only
c. Project director and subcontractor
d. Project directly and prime contractora. Subcontractor only

143.An investigator on an NIH grant has permission to rebudget $50,000 in supply monies into equipment. If the institution's facilities and administrative cost (indirect costs) rate (based on MTD) is 50%, how much money will be available for the equipment?
a. $25,000
b. $33,333
c. $50,000
d. $75,000d. $75,000

$50,000 X 1.50 = $75,000144.Involves a conflict of interestFaculty member is a major stockholder in a for profit company receiving a university contract145.Is a binding contract made between two parties, one of whom is the "Sponsor" or the company or individual sponsoring the clinical trial, while the other is the "Institution" or the organization or hospital receiving the sponsorship for conducting clinical trials.What is the Clinical Trial Agreement?146.Is intended to give credit where credit is due. Requires acknowledgement of Federal grant support when issuing statements, press releases, requests for proposals, bid solicitations, etc.What is the Stevens Amendment?147.is the grant of a property right to the inventor, issued by the Patent and Trademark Office. The term of a new patent is 20 years from the date on which the application was filedWhat is a patent?148.is to ensure that employers provide employees with an environment free from recognized hazards, such as exposure to toxic chemicals, excessive noise levels, mechanical dangers, heat or cold stress, or unsanitary conditions.What is the Occupational Safety & Health Act?149.Is usually riskier than a cost reimbursement contractWhich of the following best describes a fixed-price contract150.It is a public-private partnershipWhich of the following correctly describes FirstGov

151.It's required before an award at the proposal stage.If you don't have ERA Commons password, when is it required for an IRB?152.Judicial BranchCourts decide arguments about the meaning of laws and how they are applied. They also decide if laws violate the Constitution—this is known as judicial review, and it is how federal courts provide checks and balances on the legislative and executive branches.153."Just in time" initiatives postpone the submission of which of the following items until a decision to make an award is reached?
a. Full proposal
b. Budget justification
c. Certification and representations
d. Research background of principal investigatorc. certification and representations154.Land acquisitionIn a Construction Grant, which is allowable155.Law passed to protect certain species of marine mammals deemed as being in danger of extinctionWhat is the Marine Mammal Protection Act?156.Legislative BranchArticle I of the Constitution establishes the legislative or law making branch of government. It has a two-branch Congress—the Senate and the House of Representatives—and agencies that support Congress.157.Let SRO review the proposal then allow the PI to submitIf a federal agency requires a PI to submit online, what should be done158.Letter of supportA straight forward document stating that the institution is in support of the application to proceed and that it will host the proposed research should the application be successful.159.live, vertebrate animals onlyThe PHS policy governing the use and care of animals covers

160.Make sure budget/rates are accurate.If a PI submitted a proposal without going through the SRO office, what is our first concern?161.Mandates that a "Responsible Party" register and report results of certain "applicable clinical trials". Interventional studies of drugs, biologics, or devices that are subject to FDA regulations.What is the Food and Drug Administration Amendments Act (FDAAA)?162.Martial status of applicantUnder federal Equal Employment Opportunity provisions, a supervisor should NOT ask which of the following during an employment interview:163.Material Safety Data Sheet (MSDS) fileWhich of the following is essential to a Chemical Hygiene Plan?164.Material Transfer AgreementMTA165.Material transfer agreement (MTA)What is a contract that governs the transfer of tangible research materials between two organizations, when the recipient intends to use it for his or her own research purposes166.Material Transfer AgreementsRecommended so that disputes about use do not arise. __ are contractually binding upon the parties.167.A mechanism for procurement of a product or service with specific obligations for both sponsor and recipient. Designed to benefit the sponsor by achieving an expected outcome or product.What is a contract?168.Members of an Institutional Animal Care and Use Committee (IACUC) must be appointed
a. funding agency program officer
b. Office of Human Research Protection
c. responsible administrative official of the organization
d. research administrator responsible for the committeec. responsible administrative official of the organization

169.Member unaffiliated with the institutionAccording to federal regulations, which of the following must be included in an Institutional Review Board?170.minimum wages, maximum hours, child labor, convict labor and safe and sanitary working conditionsThe Walsh-Healey Public Contracts Act deals with issues on171.Modified total direct costIs a frequently used base for facilities and administrative cost (F&A) computation?172.modular budget is applicable only to R01, R03, R15, R21, and R34 applicationsIn an NIH Research Project Grant Program, which budget couldn't be over $25,000 in direct cost per year?173.The National Institutes of Health requires a written description of a program for providing instruction in the responsible conduct of research for:
a. program project grants
b. competing research project grants
c. noncompeting research project grants
d. Institutional National Research Service Awardsd. Institutional National Research Service Awards174.National Library of MedicineWhich of the following is located within the National Institutes of Health175.The National Science Foundation indicates decisions on the funding of grant proposals should normally takea
a. 2-4 months
b. 6-9 months
c. 10-12 months
d. 18-24 monthsb. 6-9 months176.Needs/Problem statementIt should be a clear and concise statement of the problem you want to solve with grant funds.

177.NIH: What are the main types of awardsResearch Grants (R series)
Career Development Awards (K series)
Research Training and Fellowships (T & F series)
Program Project/Center Grants (P series)178.NIH: What is Just-in-TimeRefers to the information that NIH will ask you to send after your application goes through initial peer review and is within the range of possible funding. NIH will need this information but does not require it with your application.179.Nondisclosure AgreementA Local Business wants to meet with a PI to discuss a product that they might agree to begin work on. What should be done?180.A Notice of Award typically includes which of the following?
a. Approval of facilities and administrative costs (Indirect Costs) rate
b. Award terms and conditions
c. Congressional approval
d. Guarantees for continuationb. Award terms and conditions181.Nuclear Regulatory CommissionStandards for handling radioactive materials are developed and monitored by the182.October 1The federal fiscal year begins:183.The Office and Grants and Contracts/Finance will monitor and draw cash on expenditures as appropriateThe university receives a grant from NIH that states the payment terms are DHHS Letter of Credit. This means:184.The office for Human Research Protection is administered by:
a. a private agency
b. a nonprofit foundation
c. an independent federal agency
d. a cabinet-level departmentd. a cabinet-level department

185.Office supplies, postage, administrative and clerical salaries, local telephone charges and general purpose equipmentThe following items should normally be treated as F&A cost except when the particular cost item can be justified as an exceptional need. What are some examples of exceptional need186.OMB Circular A-133The following establishes audit requirements and defines Federal responsibilities for implementing and monitoring these requirements for institutions of higher education and other nonprofit institutions receiving federal awards187.On an SF 424 Form, what does renewal, mean?requests additional funding for a period subsequent to that provided by a previous award and competes with all other applications.188.On an SF 424 Form, what does resubmission mean?has been previously submitted, but was not funded and is now being resubmitted.189.On an SF 424 Form, what does revision mean?proposes a change in 1) the Federal government's financial obligations or contingent liability from an existing organization, or 2) any other changes in the terms and conditions of the existing award, including requests for additional specific aims.190.Once each calendar year and is issued on a quarterly basisThe CFR is divided into 50 titles that represent broad areas subject to regulation and is published by the Federal executive agencies/departments. Each volume of the CFR is updated191.Payments to subjectsWhich of the following costs is allowable according to OMB Circular A-21?192.personnel salaries are increasedPrior approval from a federal agency is usually not needed when

193.The PHS policy governing the use and care of animals covers
a. live, vertebrate animals only
b. any animal use in research and training
c. animals involved in research only
d. animals that might otherwise be kept as pets onlya. live, vertebrate animals only194.PlagiarismThe appropriation of another person's ideas, processes, results, or words without giving appropriate credit195.A plan for expenditure of fundsWhich of the following must be included in every federal grant budget?196.Possible items could NIH request through Just-in-timeOther support Current and Pending, Certificate of IRB approval of proposed use of human subjects, Evidence of compliance with education in the protection of human subjects,Verification of IACUC approval of proposed use of live vertebrate animals197.Primary purpose of a federal cooperative agreementTo provide assistance with substantial involvement of the federal agency198.prior actual costA facilities and administrative cost (indirect cost) rate is usually established based on

199.Prior approval from a federal agency is usually NOT needed when:
a. the scope of work is changed
b. personnel salaries are increased
c. the principal investigator is changed
d. additional alterations costing more than $10,000 are madeb. personnel salaries are increased200.Prior intramural support should be addressed in the narrativeWhen applying for extramural support, in which of the following ways should the principal investigator address prior related intramural support?201.PrisonersWhich of the following populations has special protection as research participants under federal guidelines?202.Prisoners, pregnant women, mentally unstable, and minors.Who cannot participate in clinical trials203.Privacy Act of 1974When an agency contracts for the design, development, or operation of a system of records on individuals on behalf of the agency to accomplish an agency function, the agency must apply the requirements of which of the following acts204.Project travelWhich of the following is NOT included in the computation of an indirect cost rate205.Proposal Central or Foundation web site.What resource site do Private Foundations mostly submitted through?206.Proposal SolicitationRFP and RFA are examples of207.protection provided to the authors of "original works of authorship" including literary, dramatic, musical, artistic, and certain other intellectual works, both published and unpublishedWhat is a copyright?208.protects certain health information and requires naming a Privacy Official and written policy and procedures.What is the Health Insurance Portability and Accountability Act (HIPPA) Patient Privacy Rule?

209.protects people from discrimination based on sex in education programs or activities which receive Federal financial assistanceWhat is Title IX of the Education Amendments: Sex Discrimination?210.Protects the rights of employees and employers. Encourages collective bargaining. And curtails certain private sector labor and management practices, which can harm the general welfare of workers, businesses and the US economy.What is the National Labor Relations Act?211.Provides an entitlement of up to 12 weeks of job-protected, unpaid leave funding any 12-month period for the following reasons; birth and care of the employees child, or placement for adoption or foster care of a child with the employees; care of an immediate family member who has a serious health condition or care of the employees own serious health condition.What is the Family and Medical Leave Act?212.Provides labor standards for certain persons employed by federal contractors over $2500 furnishing services to federal agencies.What is the Service Contract Act?213.Provisions are intended to help secure the nation against bioterrorism acts.The act requires individuals and institutions to nor produce, acquire, retain (stockpile) or possess types and quantities of any biological materials including bona fide research.What is the US Patriot Act?214.provisions for an organizational program for the care and use of animalsEach organization using animals in Public Health Service sponsored projects must provide written assurance of its compliance with215.RebudgetingFederal expanded authorities permit which of the following without additional sponsored approval?

216.received from any funding sourceCost Accounting Standards (CAS) must be applied to awards217.The recipient of federal funds agrees that US flag air carriers will be used to transport personnel and property when costs are charged to these funds including any air transportation to from between or within a country other than the US when US flag air carriers are available.What is the Fly America Act?218.Recipients of federal grant funds must retain records for a MINIUMUM of:
a. 180 days after closeout
b. 18 month after the grant end date
c. 2 years after each grant budget year
d. 3 years from submission of final report of expenditured. 3 years from submission of final report of expenditure219.Refer employee to appropriate institution representativeWhich of the following is an appropriate response to sexual harassment reported by an employee in the work force?220.Regular dissemination of funding opportunitiesWhich of the following is most important in developing a program of available support with a grantee institution?221.The Regulation imposes a 6-year time limitationWhat is the time limitation for occurrences of research misconduct to be brought to the attention of an institution or the Department of Health and Human Services (HHS) (see § 93.105)222.remain with the institutionUnder federal grant conditions, the title to equipment must223.RentWhich would you charge against F&A?224.Rental or usage fees from equipment purchased with grant fundsWhich of the following is considered program income?

225.Request a one year, no cost extension of the grant while a revised continuation is under preparationA faculty member has a five year National Institutes of Health (NIH) grant which will terminate August 31, with $14,000 remaining on July 15 of the same year. A competing continuation was recommended for approval but not funded. Which of the following is the most appropriate advice for the research administrator to give to the faculty member?226.Required information on federal awards be made available to the public via single, searchable websiteWhat is the Federal Funding Accountability and Transparency Act (FFATA)?227.Requires employers to assure that employees hired are legally authorized to work in the US.What is Immigration Reform and Control Act (IRCA)?228.Requires the government to show 3 materials elements on all sole source contracts with a the current threshold applicable to all agencies is $700,000 for prime contracts awardedWhat is Truth in Negotiations Act?229.Research misconductWhat is defined as fabrication, falsification and plagiarism, and does not include honest error or differences of opinion230.responsible administrative official of the organizationMembers of an Institutional Animal Care and Use Committee (IACUC) must be appointed by the231.Responsible Conduct of Research (RCR).What process was created from America COMPETES act?232.Restricts the political activity of executive branch employees of the federal government, District of Columbia government, and some state and local employees who work in connection with federally funded programsWhat is the Hatch Act?233.Returned to the sponsoring agencyUpon completion of a federal grant, excess funds remaining in the account should be

234.RFPWhich of the following would serve the purpose of inviting proposals and specifying the general terms and conditions under which the relevant award can be made235.Roles and responsibilities of the Principal Investigator and other key personnelProper technical conduct of the research effort
Compliance with the terms and conditions of the sponsored agreement, Managing project funds within the approved budget
Timely completion and submission of required technical reports
Complying with all university and sponsor policies and procedures pertinent to the award236.Roles and responsibilities of the Sponsored Programs OfficeProviding accounting, Purchasing
Other administrative services to assist the principal investigators in: - managing the financial aspects of their projects
obtaining the necessary goods, services, and personnel to conduct the research effort, meeting sponsor needs for fiscal reports, Provides financial accounting to sponsors for the activity funded and is subject to federal audit.237.a royalty-free, nonexclusive, and irrevocable licenseFor copyrighted works which result from federally sponsored activities, the federal government usually requires238.Salaries and wagesWhich of the following is a base for facilities and administrative cost (indirect rate)?239.Salary or other payments for service, equity interests, intellectual property rights.Significant Financial Interest is defined by the regulation as anything of monetary value, including but not limited to:240.SF269The following is used to prepare quarterly, semi-annual, annual, or end reports241.SF270The following is used to request for an advance or reimbursement242.SF272The following is used to prepare a report of federal cash transactions243.Shelby AmendmentAccess to federally funded research data is required under the244.Should be closely followedWhich of the following is most appropriate use of federal agency guidelines for writing a proposal245.SponsorWhich of the following is responsible for clinical trial registration on ClinicalTrials.gov?

246.Standards for handling radioactive materials are developed and monitored by the:
a. Nuclear Regulatory Commission
b. Environmental Protection Agency
c. Centers for Disease Control and Prevention
d. Occupational Safety and Health Administrationa. Nuclear Regulatory Commission247.State and local governments are subject to which of the following OMB Circulars?
a. 2 CFR 220 (A-21)
b. A-102
c. 2 CFR 230 (A-122)
d. A-133b. A-102248.Subcontractor onlyIn the event of a cost overrun by a subcontractor, who would be held responsible by the funding source?249.Subcontractor's normal rateWhich of the following establishes the actual facilities and administrative cost (indirect cost) rate for a subcontract?250.Subcontract, Subgrant, or SubagreementA document written under the authority of, and consistent with the terms and conditions of an award, that transfers a portion of the research of substantive effort of the prime award to another institution or organization.251.System for Award Management (SAM)What is the name of the system for requiring submission and maintenance of representations and certifications252.Task Order Agreement TOAA legally binding document authorizing work and appropriating funds as a supplement to a basic contact.

253.teaching abroadThe Fulbright Program provides opportunities for254.Teaming AgreementAn agreement between two or more parties to participate in a research project or teaching activity255.Temporary rate subject to final negotiationWhich of the following best describes a provisional indirect cost rate256.They upload it to their submission application. Not on the SF 424 formIf a PI wants to request a reviewer to a proposal submission, where can they do this257.TitleIt should tell us in 25 words or less what you intend to research and should be relevant258.TravelWhich of the following expenses would be included in the distribution base of modified total direct costs?259.The travel costs do not provide any benefit to the federally sponsored projectA PI on a federally awarded grant wants to charge travel costs to a project for attendance at a conference that is unrelated to the project. Which of the following BEST explains why the PI cannot charge the travel costs to the project260.treated under organization's policy as exempt from reviewIf a principal investigator proposes to conduct research involving human subjects who will take a standardized educational test, but the test will not include any names or other identifying information, the proposal should be261.TrueUBMTA may not be usable for materials in projects supported by industry. True or False262.TrueA one-time no-cost extension up to 12 months is allowed as an expanded authority. True or False263.twice a yearThe Institutional Animal Care and Use Committee (IACUC) is required to inspect animal facilities a MINIMUM of

264.Under a federal contract, which of the following is a reason for termination for default?
a. Untimely performance
b. Budget revision
c. Cost overrun
d. Inadequate performance on another contracta. Untimely performance265.Under federal grant conditions, the title to equipment must
a. remain with the agency
b. remain with the institution
c. be vested with the institution only under $5,000
d. be vested in the institution with the agency's right to transfer to itself or another entityb. remain with the institution266.Under which of the following conditions is a Certificate of Current Cost and Pricing required?
a. For a federal contract over $1,000,000
b. For any federal subcontractor
c. From any institution that received more than $500,000 in federal funding
d. As a standard of certification submitted by institutions applying for federal grantsc. from an institution that received more than $500,000 in federal funding267.Uniform Biological Material Transfer Agreement (UBMTA)Makes one class of transfers routine
Standard terms developed in 1995 by NIH sponsored group
Provides standardized approach for certain transfers between academic institutions

268.Unilateral AwardAn award made by a sponsored to an organization without considering competitive proposals. They are most often made when unsolicited proposals receive favorable treatment.269.United States Department of Agriculture (USDA)is the U.S. federal executive department responsible for developing and executing federal government policy on farming, agriculture, forestry, and food. It aims to meet the needs of farmers and ranchers, promote agricultural trade and production, work to assure food safety, protect natural resources, foster rural communities and end hunger in the United States and abroad.270.United States Department of Homeland Securitya cabinet department of the United States federal government, created in response to the September 11 attacks, and with the primary responsibilities of protecting the United States and its territories (including protectorates) from and responding to terrorist attacks, man-made accidents, and natural disasters.271.United States Department of Veterans Affairsis a government-run military veteran benefit system with cabinet-level status. It is the United States government's second largest department, after the United States Department of Defense.272.unlike circumstances are presentA facilities and administrative cost (indirect cost) may be a direct cost if273.Untimely performanceUnder a federal contract, which of the following is a reason for termination for default?

274.Upon completion of a federal grant, excess funds remaining in the account should be :
a. returned to the sponsoring agency
b. transferred to another sponsored project
c. assigned to institution's general funds
d. included in proposal for an additional granta. returned to the sponsoring agency275.Upon receipt of awarded projects, educational institutions are required to establish?
a. credit card account for the investigator
b. combined accounts for easier investigator access
c. noninstitutional savings account for the investigators
d. individual accounts in an approved accounting systemd. individual accounts in an approved accounting system276.U.S. Department of Justice, under the False Claims ActWhich federal agency is responsible for prosecuting institutional violations of effort reporting277.U.S. Department of StateInternational Traffic in Arms Regulations (ITAR) are controlled by the278.Using the criteria contained in 2 CFR 220 (OMB Circular A-21), which of the following costs would most likely be allowable as a direct expenditure item on a federal grant?
a. Costs of preparing the grant proposal
b. Break refreshments at a project-sponsored workshop
c. Facility rental for a project staff holiday party
d. An amount specifically set aside for unanticipated expensesb. Break refreshments at a project-sponsored workshop279.Varies with funding sourceFederal regulations require that documentation of expenditures must be kept for how long?280.verifiable from recordsCost sharing must be

281.A vivariumWhat is an area, usually enclosed, for keeping and raising animals or plants for observation or research282.What are allowable costsAre costs that can be legitimately charged to a grant. An award refers to those funds that have been obligated by a funding agency for a specific project.283.What are Research Administrators?Advocate, Facilitator, Gatekeeper, Reviewer, Enforcer, Motivator, Resource Locator, Interpreter,Team Builder,Compliance Manager284.What are the roles and responsibilities of the InstitutionExpedite hiring of staff and faculty to enable work to proceed from the start of the award; Assist departments, schools, the Office of Research, and the Office of Research Accounting to facilitate administrative tasks; Meet the terms and conditions of the sponsored award in collaboration with the Investigators;-Provide timely and accurate monthly accounting reports to Investigators285.What determines if Financial Interest is SignificantFunds received for investigator and spouse/children meets both the following tests: 1) does not exceed $5000 in value as determined through reference to public prices or other reasonable measures of market value 2) does not represent more than a 5% ownership interest in any single entities.286.What is a Commercial And Government Entity Code (CAGE) and its purposeis a unique identifier assigned to suppliers to various government or defense agencies, as well as to government agencies themselves and also various organizations. It provide a standardized method of identifying a given facility at a specific location.287.What is a Data Universal Numbering System (DUNS Number)?is a system developed and regulated by Dun & Bradstreet that assigns a unique numeric identifier to a single business entity. That number is a nine-digit number issued to each business location in the D&B database having a unique, separate, and distinct operation for the purpose of identifying them.288.What is a grant?A type of financial assistance awarded for the conduct of research and no substantial programmatic involvement with the recipient during the performance of the activities.289.What is an Invitation For Bid (IFB)?the method used for the sealed bid process. A contract is then awarded to the low bidder whose bid conforms with all requirements of the invitation and will be advantageous to the government in terms of price, and price-related factors

290.What is a Request for Proposal (RFP)?occurs when the agency isn't certain about what it wants and is looking to you to develop a solution and cost estimate.291.What is a Request for Quote (RFQ)is often used to determine current market pricing, but is not a binding offer and can't be accepted by the government. A Standard Form 26, which requires the signatures of both the contractor and the contracting officer, would be required to make the offer binding.292.What is a Student Visa?Generally, a citizen of a foreign country who wishes to enter the United States must first obtain a visa, either a nonimmigrant visa for temporary stay, or an immigrant visa for permanent residence. You must have a student visa to study in the United States. Your course of study and the type of school you plan to attend determine whether you need an F-1 visa (academic) or an M-1 visa (vocational).293.What is Catalog of Federal Domestic Assistance (CFDA)?is a government-wide compendium of an online database listing all available federal programs.294.What is debarment?removes you as a contractor from eligibility for future government contracts for a fixed period of time.295.What is Drug Free Work ForceDOD contractors must maintain records regarding drug-free work force programs provided to their employees. Also establishes a program testing for the use of illegal drugs by employees.296.What is effort reportingThe percentage of total employment devoted to a particular project, activity, administrative task297.What is Equal Employment Opportunity?provide equal opportunity without regard to race, color, religion, sex, or nationality to persons employed or seeking employment298.What is Fair Labor Standards Act?Enacted to establish a minimum hourly wage, overtime pay and regulate child labor299.What is Health Resources and Services Administration (HRSA) and who do they fall underimproves access to healthcare for people who are uninsured, isolated, or medically vulnerable and under DHHS.

300.What is Lobbyingthe act of attempting to influence decisions made by officials in the government, most often legislators or members of regulatory agencies.301.What is Small Business Innovative Research (SBIR)?refers to the agency administered programs that are supported by ear-marked federal funds, making grants to small business entities302.What is Small Business Technology Transfer (STTR)?refers to the grant applications and/or programs for funding those small business that are teamed up with research institutions.303.What is suspension?temporarily debars a contractor for the duration of any agency investigation of the contractor or ensuing legal proceedings.304.What is the America COMPETES Act?America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education and Science- focuses on increasing research investment
Strengthens STEM Research (science, technology, engineering and math) from elementary through grad school.305.What is the Buy America Act?Establish a general preference for domestic articles, materials/supplies to protect the American worker by saving and creating jobs.306.What is the Byrd Amendment?Institution must certify that no appropriated funds were or will be expended to pay any person for influencing or attempting to influence an officer or an employee of any agency, a member of Congress, an officer or employee of Congress in connection with a specific award.307.What is the Civil Rights Act?Bars recipients of federal funds from excluding persons because of race, sex, color, or national origin from participation in receiving benefits or otherwise subjecting them to discrimination under federally supported programs or activities. Law also interpreted to cover discrimination against those persons with limited English. Sex includes pregnancy, childbirth or related medical conditions.308.What is the Confidentiality of Patient Records?Enacted to protect persons with substance abuse problems who seek treatment.309.What is the Davis/Bacon ActRequires contractors to pay wages to laborers and mechanics at a rate of no less than a minimum wage specified in a wage determination made by the Secretary of Labor.

310.What is the Drug Free Workplace ActIt says you can't receive federal funding if you do not have a drug-free workplace policy in place311.What is the Endangered Species Act?species listed as endangered or threatened prohibits the unauthorized taking, possession, sale and transport of those species312.What is the Equal Pay Act?act prohibits employers and unions from paying different wages based on the employees sex313.What is the False Claims Act?Improper costing, product substitutions, failure to comply with contract specifications and filing false claims with government health care programs314.What is the percentage that all STTR budgets must matchAt least 40 percent of the STTR research project is to be conducted by the small business concern and at least 30 percent of the work is to be conducted by the single "partnering" research institution.315.What is the Ruth L. Kirschstein NSRA Award? Why is it importanttrain fellows and residents, and are used to promote the education of future researchers. She was a champion of research training and a strong advocate for the inclusion of underrepresented individuals in the scientific workforce316.What is the Solomon Act (Amendment)/ National Defense Authorization ActWhat United States federal law that allows the Secretary of Defense to deny federal grants (including research grants) to institutions of higher education if they prohibit or prevent ROTC or military recruitment on campus.317.What is use of name exceptionIt's an exception that agree that neither party will use directly or by implication names or trademarks of the other party in connection with any publicity, promotion or advertising without prior written approval.318.What is voluntary committed cost sharing?when the proposing institution volunteers and commits to bear a specific portion of the costs of the project when it is not required.319.What is voluntary uncommitted cost sharing?when the PI chooses to expend some unspecified amount of effort more than proposed towards the award. This is usually the case when the PI is not requesting salary from the award, and so is volunteering his/her effort.

320.When applying for extramural support, in which of the following ways should the PI address prior related support?
a. Prior intramural support should be ignored
b. Prior intramural support can be considered as an item of cost sharing in the budget narrative
c. Prior research related support should be considered unrelated in current grant request
d. Prior intramural support should be addressed in the narratived. Prior intramural support should be addressed in the narrative321.When a subaward is involved in a federal grant to a large university, on what portion of the subawardee's budget does the prime institution recover facilities and administrative costs (indirect costs)?
a. None of it
b. The first $25,000
c. The subawardee's modified total direct cost amount
d. The amount is excess of $25,000b. The first $25,000322.Whenever covered animals are involved in a protocolWhich of the following requires Institutional Animal Care and Use Committee (IACUC) review and approval governing the use of animals?323.When granted expanded authorities pre-award costs on a federal grant may be incurred by an institutional within
a MAXIMUM of how many days prior to the official start date:
a. 30 days
b. 45 days
c. 90 days
d. 120 daysc. 90 days

324.Which federal agency is responsible for prosecuting institutional violations of effort reporting?
a. U.S. Department of Justice, under the False Claims Act
b. Government Accountability Office, under the Code of Federal Regulations
c. Office of Management and Budget, under OMB Circular A-133 Audit Requirements
d. National Science Foundation Office of the Inspector General, under Congressional Oversight Authoritya. U.S. Dept of Justice, under the False Claims Act325.Which of the following agencies does NOT fund health science research?
a. U.S. Army
b. Department of Energy
c. National Institute of Aging
d. National Science Foundationd. National Science Foundation326.Which of the following agencies is responsible for administering the Animals Welfare Act?
a. Public Health Service
b. Department of Agriculture
c. Environmental Protection Agency
d. American Society for Prevention of Cruelty to Animalsb. Department of Agriculture327.Which of the following are two critical termination clauses of General Provisions of a federal contract:
a. Dispute and changes
b. Default and convenience
c. Default and stop work order
d. Stop work order and failure to confirmb. Default and convenience

328.Which of the following best describes 2 CFR 220 (OMB Circular A-21)?
a. Is applicable only to NSF and NIH
b. Allows federal agencies to places additional restrictions on individual items of costs
c. Deals with cost determination but does not identify the circumstances or dictate the participation in the financing of a project
d. Establishes principles for determining costs applicable to contracts, grants, and other agreements with both educational institutions and hospitalsc. Deals with cost determination but does not identify the circumstances or dictate the participation in the financing of a project329.Which of the following best describes federal regulations governing the use of humans in research?
a. Allow the researcher full discretion as to what to include in informed consent materials
b. Always require full informed consent on the subject or the subject's guardian
c. Allow the Institutional Review Board discretion in limited situations to approve protocols providing less than full informed consent
d. Waive full informed consent of the subject when the protocol is too complicated for an individual subject to understand the risksb. Always require full informed consent on the subject or the subject's guardian330.Which of the following delegates to grantee authorization of one year, no-cost extensions?
a. Expanded Authorities
b. Cost Accounting Standards
c. Public Law 106-107
d. Code of Federal Regulationsa. Expanded Authorities331.Which of the following establishes the actual facilities and administrative cost (indirect cost) rate for a subcontract?
a. Prime recipient's rate
b. Prime award agreement
c. Subcontractor's normal rate
d. Agreement between subcontractor and funding agencyc. Subcontractor's normal rate

332.Which of the following expenses would be include in the distribution base of modified total direct costs?
a. travel
b. equipment depreciation
c. sponsored programs office expenses
d. the portion of each subcontract in excess of $25,000b. equipment depreciation333.Which of the following information must be included in the notification by a federal officer to the contractor to terminate a contract for convenience?
a. Signature of program office
b. The effective date of the contract
c. A citation of the contract clause authorizing the termination
d. A specific statement defining the reason for the termination noticed. A specific statement defining the reason for the termination notice334.Which of the following involves a conflict of interest?
a. Faculty member owns and operates a business outside of university commitment
b. Faculty member consults with outside business in area of expertise
c. Faculty member supervises students employs them in university sponsored projects
d. Faculty member is a major stockholder in a for-profit company receiving a university contractd. Faculty member is a major stockholder in a for-profit company receiving a university contract335.Which of the following is a base for facilities and administrative costs (indirect costs)?
a. Subcontracts
b. Capital Equipment
c. Salaries and wages
d. Professional and outside servicesc. Salaries and wages336.Which of the following is a frequently used base for facilities and administrative costs (indirect cost) computations
a. Nonsalary costs
b. Capitalized equipment
c. Modified total direct cots
d. Total direct costs less pre-award costsc. Modified total direct cots

337.Which of the following is allowable as cost sharing?
a. Equipment donated at fair market value
b. Alcohol purchased for an allowable business dinner
c. A portion of the salary of the department head's secretary
d. Travel costs in excess of institutional per diema. Equipment donated at fair market value338.Which of the following is a primary purpose of a federal cooperative agreement?
a. To allow for flexible budgeting
b. To provide assistance with few restrictions
c. To enable solicitation by a Request of Proposal
d. To provide assistance with substantial involvement of federal agencyd. To provide assistance with substantial involvement of federal agency339.Which of the following is essential to a Clinical Hygiene Plan?
a. Material Safety Data Sheet (MSDS) file
b. Monthly fire and safety drills
c. Public information program
d. Federal Food & Drug Administration inspectiona. Material Safety Data Sheet (MSDS) file340.Which of the following is included in 2 CFR 215 (OMB Circular A-110)?
a. Audit requirements
b. Debarment and suspension rules
c. Federal contact requirements
d. Cost principles for nonprofitsb. Debarment and suspension rules341.Which of the following is located within the National Institutes of Health?
a. National Library of Medicine
b. Centers for Disease Control and Prevention
c. Food and Drug Administration
d. National Institute for Occupational Safety and Healtha. National Library of Medicine

342.Which of the following is mandated for the oversight of research involving recombinant DNA?
a. rDNA Committee
b. Biosafety Ethics Committee
c. Institutional Biosafety Committee
d. Institutional Biohazard Committeec. Institutional Biosafety Committee343.Which of the following is most important in developing a program of available support within a grantee institution?
a. Hiring of information specialist
b. Regular dissemination of funding opportunities
c. Development of subject-related database
d. Establishment of potential investigator fileb. Regular dissemination of funding opportunities344.Which of the following is responsible for clinical trail registration of Clinical Trials.gov?
a. Sponsor
b. Institution
c. Sponsored research office
d. Institutional Review Board (IRB)a. Sponsor345.Which of the following populations has special protection as research participates under federal guidelines?
a. Elderly
b. Prisoners
c. College Students
d. Persons diagnosed as HIV positiveb. Prisoners346.Which of the following requires Institutional Animal Care and Use Committee (IACUC) review and approval governing the use of animals?
a. When any animal is used
b. Only when laboratory animals are used in instruction
c. Whenever covered animals are involved in a protocol
d. Only if a protocol involve sacrificing animalsc. Whenever covered animals are involved in a protocol347.Which of the following sources in NOT commonly used for FEDERAL funding opportunites:
a. The Federal Register
b. The Foundation Directory
c. Commerce Business Daily
d. The Catalog of Federal Domestic Assistanceb. The Foundation Directory

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

Here are some courses you might consider:

• Clinical Research Coordinator Certification - Ideal for those looking to coordinate clinical trial activities.

• Pharmacovigilance Certification - Focuses on drug safety and adverse effects management.

• CRA Certification - Prepares you for the role of Clinical Research Associate.

• ICH-GCP Certification - Essential for professionals needing to understand Good Clinical Practice guidelines.

• Clinical Trials Assistant Training - Provides foundational knowledge for those starting in clinical trials.

• Advanced Clinical Research Project Manager Certification - For experienced professionals aiming for project management roles.

• Advanced Principal Investigator Physician Certification - Tailored for physicians leading clinical trials.

• Medical Monitor Certification - Designed for those overseeing the medical aspects of clinical trials.

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How to Improve My AMCAS Work & Activities

Applying to medical school can be difficult, but it can also be one of the most important decisions of your life. The AMCAS is the American medical school application system that all students use. A rich, well put together application can help you get into your dream school. Below are four simple ways you can improve your AMCAS Work & Activities

Expand your system

As an aspiring health care practitioner, you may be wondering exactly what you have to do in order to scale the corporate ladder. While improving your skills and practice helps your career in the medical sector as well as every other profession, progressing your health care profession will need more than perfect bedside manners.

Remember that as you expand and grow, the exact same occurs for your health care career. The five questions highlighted below are the guide to the first actions that will assist you to get a location you would like from the area of medicine. Practice them, along with your healthcare profession will expand also.

Are your interests Dealing with your career route? Here is the very first question you need to have the ability to answer frankly in the event that you would like to improve your career in the health care market. Furthermore, if you're still not in the health care field, you need to ask yourself whether you may achieve the skills and instruction together with the experiences required to realize your objective. You might even elect for clinical research partner training for a means to improve your own comprehension.

Make the most of the onsite courses in addition to any instruction opportunities being provided. Besides that, additionally, there are hospital control and Clinical Research online classes being supplied at some prestigious schools, including McMaster University and James Lind Institute. As previously stated, choosing a clinical research partner instruction is a wonderful method to raise your probability of progressing since the longer you improve, the further you're generating opportunities for your own.

Stay ready, driven and motivated

You always should stay concentrated on the job at hand and being ready for everything and anything that comes your way. It is a very good method of demonstrating that you just take your career seriously. Regardless of what the job you're accountable for, whether large or little, always be ready for it. Additionally, don't forget to get centered on your potential career goals too, even though it feels like the progress you would like is farther away than you originally envisioned. Maintain those friends that are interested in exactly precisely the exact identical field near. You are able to think about these as motivators who drive you to keep on chasing your dream.

Picking a mentor has a few benefits, that will, in turn, assist you in improving your health care career. If you locate a suitable individual that's eager to take you under their wing, then begin with taking a good look at the job ethics and degree of knowledge. This will definitely point you in the ideal way, as you'll be asking yourself how you are able to be like these. Second, your mentor might assist you to network with other seasoned professionals who he/she understands.

Your present or former teacher from medical college will even share his wisdom and adventures with you. This may be a fantastic place to look for out information on whatever that you would like to learn regarding your health career. Utilizing the adventures of your mentor or boss since your aims may be the simplest route to follow if you would like to advance professionally.

Re-evaluate your livelihood

Another great approach to progress your career is by simply linking with likeminded people who work as caregivers. These professionals are available literally anywhere -- the establishment you've have your health care degree from, in your current (and past ) job, in seminars and conventions, in LinkedIn classes, etc.. ) If you would like to branch out farther than the men and women in your institution, you can attempt using online social networks to associate with more people just like you. Conventional social networks like working on your area and associations also work miracles.

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

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CCRPS Clinical Research Certificate Program Overview

The First Step to Clinical Research Certificate Program

_________________________________________________________________________________

CCRP CRRA Certified Clinical Researcher Associate

This program requires only a medical sciences education background such as FMGs, BSNs, and Bachelors graduates. Clinical Research Associate Training Course is a 110 module course led by Senior CRA and Physician of 25 Years, Dr.Kamal. This course provides the training, experience, interviewing, letter of references, and connections you need to get a job supervising clinical research efforts. We offer clinical research associate training and placement for nurses, science bachelor graduates, and international medical graduates.

For those interested in expanding their knowledge and skills, consider enrolling in the CRA or the Advanced Clinical Research Project Manager Certification courses for further specialization.

_________________________________________________________________________________

SCDM CCDM Certified Clinical Data Manager

Eligibility Requirements

APPLICANTS FOR THE CERTIFIED CLINICAL DATA MANAGER (CCDM™) PROGRAM MUST MEET ONE OF THE FOLLOWING CRITERIA

• Bachelor’s degree or higher and minimum two years full-time CDM experience

• Associate’s degree and minimum three years full-time CDM experience

• Four or more years full-time CDM experience

• Part-time work experience equal to or surpassing full-time equivalent in criteria above

ACRP CCRA Certified Clinical Research Associate

The CCRA® eligibility criteria define the minimum experience required before a CRA can apply for the program. It is important to compare the CRA eligibility criteria with your career and educational experiences to self-determine your eligibility before submitting an application and payment. All applications must undergo a formal review process to determine an applicant’s eligibility to sit for the exam.

CRA Certification Eligibility Requirements

In order to be deemed eligible to take the CCRA® exam, applicants for the CCRA® credential must be able to provide evidence through a job description, detailed CV, or other documentation that they:

• Work independently of the investigative staff conducting the research at the site or institution. This means they do not report to the PI or site manager and that they do not have the ability to change or manipulate data, and;

• Work on behalf of the sponsor. This means that they are contracted by the “sponsor” to perform an independent monitoring function. The “sponsor” can be a pharmaceutical or device company, a granting agency, a university department, a physician, etc., and;

• Perform all of the CCRA® essential duties as detailed below for a required minimum number of hours. Hours performing the CRA essential duties can include hoursdocumented up to the date of the exam and/or through previous employment. The required number of hours is dependent upon one’s educational background.

The CRA Certification Handbook has complete information on eligibility requirements.

ACRP CCRC Certified Clinical Research Coordinator

CRC Certification Eligibility Requirements

In order to be deemed Eligible to take the CCRC® exam, applicants for the CCRC® credential must be able to provide evidence through a job description, detailed CV or other documentation that they:

• Perform all of the CRC essential duties as detailed below for a required minimum number of hours.

• Hours performing the CRC essential duties can include hours documented up to the date of the exam and/or through previous employment. The required number of hours is dependent upon one’s educational background.

For those pursuing a career as a Clinical Research Coordinator, the Clinical Research Coordinator course provides essential training and certification.

SoCRA CCRP Certified Clinical Research Professional

The applicant must be working with Good Clinical Practice (GCP) guidelines under IRB/IEC/REB-approved (or specifically exempted) protocols.

The applicant must meet one of the following Eligibility Criteria noted below.   Please note that most candidates will be eligible under Category 1. 

For purposes of eligibility, please view SOCRA's definition of a Clinical Research Professional.

If you have a question about Candidate Eligibility please email SOCRA at certification@socra.org

Consider enhancing your understanding of GCP with the ICH-GCP course.

Category 1

Applicant must have (and be able to document) ALL of the following qualifications:

• Have two years of experience as a full-time Clinical Research Professional (or have 3,500 hours part-time) during the last five years

Please note:  If you have completed two (2) years of full-time employment as a clinical research professional in the past five years, you will NOT need to provide supporting documentation for your educational experience.

Category 2

Applicant must have (and be able to document) ALL of the following qualifications:

• Hold a degree in "Clinical Research" from an Associate, Undergraduate, or Graduate Degree Program AND 

• Have completed a minimum of one year of full-time experience (or 1,750 hours part-time) during the past two years as a Clinical Research Professional

Category 3

Applicant must have (and be able to document) ALL of the following qualifications:

• Hold an Undergraduate or Graduate Certificate in “Clinical Research” with a curriculum of no less than 12 semester (credit) hours or totaling a minimum of 144 credit hours from an academic institution of higher learning (community college, college or university) AND

• Hold an Associate’s or Bachelor’s Degree in a science, health science, pharmacy or related field AND 

• Have completed a minimum of one year of full-time experience (or 1750 hours part-time) during the past two years as a Clinical Research Professional.

ACRP CCTI Certified ClinicPrincipal Investigator

The CPI® eligibility criteria define the minimum experience required before a PI can apply for the program. It is important to compare the CPI® eligibility criteria with your experience to self-determine your eligibility before submitting an application and payment. All applications must undergo a formal review process to determine an applicant’s eligibility to sit for the exam.

PI Certification Eligibility Requirements

In order to be deemed eligible to take the CPI® exam, applicants for the CPI® credential must be able to provide evidence through a job description, detailed CV or other documentation that they:

• Have a doctorate level degree and;

• Have proof of employment as a PI during at least two (2) of the most recent five (5) years and;

• Perform all of the essential duties as detailed below.

The PI Certification Handbook has complete employment definitions.

Update: The CPI Exam is the first exam being offered to all investigators with a doctoral-level degree. A license to practice medicine is no longer required.

NAIM CIM Certified IRB Manager

To qualify for the Certified IRB Manager Examination, you must meet the following
requirements:
     • Applicants must have a Bachelor’s Degree and 2 years of relevant IRB
      Management experience within the last 5 years.
      OR
     • An Associates Degree from a two year college or technical school and 2 years
      of relevant IRB Management experience within the last 5 years.

CCIP CIP Certified IRB Professional

Eligibility Requirements

This certification program is for individuals whose primary job responsibilities include substantial participation in overseeing, administering or performing the daily activities of an IRB as part of a HRPP. Individuals involved in IRB activities who meet the following eligibility requirements are eligible to take the examination: 

• A Bachelor's degree plus two years of relevant HRPP experience, completed on or before the first day of your chosen testing period (see front cover)

or

• Three years of relevant HRPP experience, completed on or before the first day of your chosen testing period

or

• Current certification as a CIP

RACC CRA Certified Research Administrator

Bachelor’s Degree and three (3) years of professional experience in research or sponsored programs administration either in a sponsoring or recipient organization or the equivalent in a self-funded organization;

OR

An Associate’s Degree and five (5) years of professional experience in research or sponsored programs administration either in a sponsoring or recipient organization or the equivalent in a self-funded organization;

OR

No degree and six (6) years of professional experience in research or sponsored programs administration either in a sponsoring or recipient organization or the equivalent in a self-funded organization. *

MAGI CRCP Certified Research Contract Professional

People often ask how to prepare for the exam. Two years of experience with a variety of negotiation partners may be sufficient to pass the exam. A careful reading of MAGI's Model CTA, Clinical Trial Agreement Handbook (Original), and Model CDA is helpful. There are numerous relevant articles in the Journal of Clinical Research Best Practices. Attending MAGI's Clinical Research Conference is good preparation, provided you attend sessions and workshops that address relevant topics where you need more knowledge. Sample questions, study guides, or other study materials are not available. However, imagine an exam for professional chefs. One question might be, "Describe the process of making an omelette." Another might be, "List five spices used in Chinese cuisine." Another might be, "What are the pros and cons of gas vs. electric stoves?"

RAPS RAC Regulatory Affairs Certification

The RAC is the only credential for regulatory professionals in the healthcare product sector. The RAC demonstrates to employers, clients and colleagues essential knowledge, critical thinking abilities and a commitment to continuing professional development. It is designed for working regulatory professionals, with at least three to five years of regulatory experience. There are six different RAC exams. The US, EU and Canada exams test regional regulations and involvement with regulatory bodies. The global exam focuses on international standards and guidelines. The devices and drugs exams have a global focus yet aligns to a specific sector of regulation knowledge. All six exams test for regulatory knowledge, critical thinking and analysis throughout the lifecycle of a product.

SQA RQAP Registered Quality Assurance Professional

The Society of Quality Assurance is proud to offer the professional credential Registered Quality Assurance Professional (RQAP) for professionals working in Good Laboratory Practices as well as for professionals working in Good Clinical Practices. Registration is a recognized standard of experience and knowledge throughout the QA industry, in the US and around the world.

What the credential demonstrates

• Proof of your knowledge of the regulations/guidelines and how they are applied

• Commitment to a high quality standard in the QA industry

• Personal professional growth and achievement

How it Works

1. Professionals must pass an examination in either Good Laboratory Practices or Good Clinical Practices to receive the RQAP credential.

2. Registered professionals must re-register every three years by submitting documentation of ongoing professional activities. These activities include, but are not limited to:

   • Attending the SQA Annual Meeting and/or Quality College

   • Attending events of SQA Regional Chapters

   • Attending events of relevant professional associations/societies, e.g. JSQA, RQA, RAPS, DIA, ACS, ACRP, NAICC, AALAS, etc. (See our MOU Organizations and Liaison Organizations.)

   • Completing courses in the SQA Online Learning Center

   • Attending SQA webinars or webinars offered by relevant professional organizations

   • Studying the SQA Annual Meeting Online Library

   • Participating in the SQA Mentoring Program

   • Writing test items for an RQAP exam

More on RQAP Re-registration

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

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From The Course Creator: CRA Clinical Research Certification & Training

Clinical research associates are currently the highest paid upper-level medical professionals in the pharmaceutical and medical industry, second only to physicians. Many remote and traveling (expenses-covered) jobs are available for CRA positions for those who have a background or certification training. If you're looking to further enhance your qualifications, consider our Clinical Research Coordinator course or our comprehensive CRA training.

The obvious difficulty in searching for these positions is getting selected and interviewed without experience. CCRP Course works directly with:

• International Medical Graduates (MBBS, FMG, IMGs)

• MDs without residence

• Bachelor’s of science or healthcare-related fields

• Bachelor’s of nursing and nurses

• Master’s of science graduates

CCRPS’ courses strives for you to achieve the knowledge, certification, and resume experience needed to be selected and hired by pharmaceutical companies. For those involved in monitoring, consider our Medical Monitor Certification to boost your credentials.

CRAs can expect to make between $75-90k/year within their first year. CRAs who are physicians from foreign countries are considered MDs in this position. CRAs who are transitioned nurses are treated remarkably well among the hospitals they visit or monitor. This role also offers pathways into higher-level administrative and leadership roles in medical centers, institutions, and pharmaceutical companies, which can be further supported by our Advanced Principal Investigator Physician Certification and Advanced Clinical Research Project Manager Certification.

As a supervisor of clinical trials, this position also paves ways to enter higher-level administrative and leadership roles in medical centers, institutions, and pharmaceutical companies.

Courses for Quality CRA Training                   Modules per Course      

1. ICH GCP Training                                                     15                                              

2. Quality Monitoring                                                     45                                           

3. Regulatory Training                                                   15                                            

4. Audit and Inspections                                                 6                                           

5. Writing Professional Monitoring Reports                    16    
-Developing Follow Up Reports                                         

6. Subject Recruitment Retention and Compliance         5                   

7. Misconduct and Fraud                                                2                     

8. Competency Testing of CRA’s                                     6               

                                                                                     …………                                                                                        Total         110 Modules 

Training certification will be provided at the end of the course. This can be listed on your resume as an educational experience as well as a volunteer experience for the amount of time it takes you to complete the course.

The tuition fee is $1,795 ($18 per module) is offered over a 4-month payment plan in this link. 

The online training can be completed within 1-4 months time and can start within 24 hours of tuition payment.

After module completion we begin your recruiter-interaction training by providing the following: 

1.   Interview Prep (3 interview rounds training) 

2.   Resume experience of training 

3.   Recruiter based references 

4.   Multiple employee references

5.  LOR’s  

Having been a Senior CRA for 15 years, my job is to ensure that entering and succeeding this field is easier for our students. If you are interested in this field, below are some CRA articles you may find useful.

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

About CCRPS

CCRPS Clinical Research Certification

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Certified Clinical Research Professionals Society (CCRPS) educates the drivers of clinical trials research worldwide through our certification program. We are a Virginia-based 501(c)(3) not-for-profit professional organization serving all people involved in clinical trials from volunteers to professionals. Our mission is to support clinical trials by providing accessible education to entry and mid level professionals.

As part of our duty to provide accessible education, we offer free ICH GCP certification (good clinical practice gcp) recognised by Transcelerate Biopharma for all students, businesses, and professionals.

We provide clinical research associate, clinical research coordinator, clinical research assistant, ICH GCH, pharmacovigilance drug safety, and international clinical research certifications accredited and peer reviewed by the ACCRE. Healthcare professionals can also receive ACPE, AMA/ACCME, ANCC, and ICPE continuing education credits through our clinical research online training.

Learn more about our cra certification through our clinical research associate certificate.

Get answers to your questions regarding the online course immediately by chatting with our team online. You can demo all of our courses for free by clicking below.

Our Clinical Research Courses

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CCRPS is uniquely positioned to provide accredited certification courses for entry level professionals due to our in-depth content. All courses can be accessed immediately after enrolling. Students have 2 attempts to pass the certification exam with a minimum of 70% in order to receive their certificate. Our courses are are entirely online, self-paced, and can be completed in between 1 week - 12 weeks, depending on the content matter and your schedule. Students can apply for partial scholarships or enroll for a payment plan for CRA and CRC certification courses. To get more information regarding our partial scholarship, chat with our enrollment agents online. Scroll down to learn more about our accreditation, certification, and CME credit provisions.

Advanced Certifications:

• Advanced Clinical Research Project Manager Certification

• Advanced Principal Investigator Physician Certification

• Medical Monitor Certification

Clinical Research Training and Job Placement

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CCRPS, like other educational institutes, is only associated with educating and certifying clinical research professionals, so we do not provide job placement. However, we want to make sure you apply with your best foot forward. Below are links we readily refer to graduates who are looking for job support. Having a great CV and cover letter are essential to applying for jobs. Recruiters are paid by the company which hires you and thus are free for searching employees. Be realistic but also be driven. Make sure you reach out if you received no response, as the company may never have seen your application.

Clinical Research Job Advising: Kunal at ClinicalTrialPodcast

Free Resume Review: TopCV TopCV provides a free review and feedback for your current resume.

Resume Distribution: ResumeRabbit Resume rabbit distributes your resume to 60 job posting sites.

Clinical Research Recruiters: I-Recruit I-Recruit distributes your resume to clinical research recruiters.

Clinical Research Job Bulletin: Indeed Indeed usually provides the most uptodate job bulletin for clinical research jobs

CCRPS FAQS

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CCRPS Reviews and Testimonials

CCRPS has trained over 1,700 professionals to date. Our students continue to provide us great feedback through email, online, and other methods. Below are some audio and video testimonials students have shared with us. Students benefit from hearing what past students have to say as well as trying the course demo online.

Accreditation for CCRPS Courses

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ACCRE - CLINICAL RESEARCH PROFESSIONALS

CCRPS CRA Certification and CRC Certification is accredited by The Accreditation Council for Clinical Research Education (ACCRE) in June 2019 Code: 463-03-005-GPC08

ACCRE accredits professional programs in Clinical Research leading to the Certificate of Clinical Research. The ACCRE is recognized for the accreditation and pre-accreditation of professional programs in Clinical Research by the biotechnology and pharmaceutical industries. ACCRE accreditation serves to establish standard eligibility for participation in a variety of biopharmaceutical industry funded programs. For students and prospective students, accreditation provides an assurance that a program has been found to provide satisfactory educational preparation for practice in the field

JOINT ACCREDITATION - PHYSICIANS, NURSES, PHARMACISTS, HEALTHCARE PROVIDERS

• Advanced Clinical Research Professionals Foundations (ACRP-F)

• Release date: 07/14/2020 Expiration date: 07/14/2021

• Estimated time to complete activity: 17.5 hours

• Contact PIM

Jointly provided by Postgraduate Institute for Medicine (PIMED) and Certified Clinical Research Professionals Society (CCRPS)

This activity is intended for physicians, nurses, pharmacists, and professionals engaged in care of patients in clinical trials. 

Educational Objectives

After completing this activity, the participant should be better able to:

• Describe the ICH GCP protocol including FDA 21 CFR, E2A, 5,5 E6, and Ethics

• Explain the Quality Monitoring process including designing trials, site visits, monitoring visits, close out visits, protocols, and reporting violations. 

• Outline the process and professional roles involved in audit and inspections.

• Appropriately detect and report misconduct and fraud.

• Apply concepts of clinical research roles in a multiple choice examination.

Faculty

Dr.Kamaljit Tiwana, Diedre Clarke, Sahar Khan

Program Agenda

This program is self-paced and can be completed at the time desired by the student.

Joint Accreditation Statement

In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and Certified Clinical Research Professionals Society (CCRPS).  Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

ACCME / AMA - PHYSICIAN CME

The Postgraduate Institute for Medicine designates this enduring material for a maximum of 17.5 AMA PRA Category 1 Credit(s)™ (CME). Physicians should claim only the credit commensurate with the extent of their participation in the activity.

ACPE - CONTINUING PHARMACY EDUCATION

Postgraduate Institute for Medicine designates this continuing education activity for 17.5 contact hour(s) (17.5 CEUs) of the Accreditation Council for Pharmacy Education. 

Universal Activity Number - JA4008162-9999-20-2166-H04-P

Type of Activity: Knowledge 

ANCC - CONTINUING NURSING EDUCATION

The maximum number of hours awarded for this Continuing Nursing Education (CNE) activity is 17.5 contact hours.

ICPE - HEALTHCARE PROVIDERS INTERPROFESSIONAL CONTINUING EDUCATION

This activity was planned by and for the healthcare team, and learners will receive 17.5 Interprofessional Continuing Education (IPCE) credit for learning and change.

TRANSCELERATE BIOPHARMA - ICH GCP

Recognizes CCRPS Certification as Evidence of GCP Training. CRA, CRC, and ACRP-F certification available by CCRPS meet the criteria for GCP training. We are recognised by the 20 major TransCelerate associated BioPharma companies through mutual-recognition to prevent overlap in GCP training.