The Ultimate Guide to Clinical Research Monitoring

Clinical research monitoring plays a crucial role in the success of clinical trials, encompassing diverse activities to guarantee the safety and precision of collected data. The execution of clinical trials must adhere to regulatory standards, prioritize the protection of human study participants, and minimize potential health risks. Monitoring activities include auditing study sites, assessing data accuracy and completeness, protocol and amendment reviews, scrutiny of case report forms (CRFs), identification of deviations from standard operating procedures (SOPs) or protocols, management of corrective action plans (CAPs), safety report follow-ups, and tracking progress against enrollment goals.

For those interested in becoming involved in clinical trial management and oversight, the Advanced Clinical Research Project Manager Certification offers extensive training in these key areas.

Beyond data quality assessment, clinical research monitoring ensures compliance with regulatory standards such as GCP (Good Clinical Practices), ICH (International Conference on Harmonization), FDA regulations, and local laws. Those looking to deepen their understanding of these standards might find the ICH-GCP course particularly beneficial. Ongoing monitoring throughout a study, coupled with potential audits by sponsors or regulatory authorities, contributes to the accuracy, reliability, and applicability of clinical trial results for informed medical decisions.

Steps to Clinical Monitoring:

1. Craft a Robust Monitoring Strategy: Develop a thorough monitoring plan encompassing essential elements. This includes specifying the types of monitoring activities, setting the frequency of monitoring visits, outlining data collection methods, and establishing clear criteria for acceptable performance.

   • Aspiring Clinical Research Coordinators can enhance their strategy formulation skills through the Clinical Research Coordinator course.

2. Create Effective Documentation: Develop monitoring tools tailored to the protocol, including forms for recording information from site visits, source documents, data collection instruments, and case report forms (CRF). Additionally, establish a Monitoring Log or Tracking System to enhance accountability for study activities.

   • For detailed training on documentation practices, consider the Clinical Trials Assistant Training.

3. Conducting Monitors' Visits: Depending on the trial's complexity and regulatory mandates, execute pre-study qualification visits (PSQV), pre-initiation visits (PIV), initiation visits (IVs), periodic monitoring visits (PMV), and close-out visits (COV). Throughout each visit, uphold good clinical practice standards by thoroughly reviewing source documents and data collection instruments. Scrutinize patient enrollment logs for accuracy, noting any discrepancies in the comprehensive visit report.

   • The CRA course provides in-depth training for those looking to conduct these critical visits.

4. Reporting Findings: Create comprehensive yet succinct reports after each monitor's visit, offering clear recommendations for corrective actions as needed. Provide professional feedback to investigators, highlighting their performance. Identify and address any noncompliance with protocol requirements or regulations, suggesting training or educational sessions when necessary. Track all follow-up activities related to corrective actions taken in response to monitor's visit findings. Ensure the completion of essential documentation before closing out a specific study site.

   • Those interested in the oversight of safety reporting might explore the Pharmacovigilance Certification.

5. Ensuring Quality Assurance: Validate the accuracy of tracking systems employed by monitors during their visits. Assess the risks linked to identified deficiencies throughout the monitoring process. Conduct regular internal audits/assessments to guarantee compliance with established SOPs/guidelines pertaining to clinical research monitoring activities. Implement preventive measures based on audit/assessment results to enhance internal quality system processes.

   • Professionals aiming for a specialized role in this field might consider the Medical Monitor Certification.

Types of Clinical Trial Monitoring

1. Onsite Monitoring: Onsite monitoring, considered the "gold standard," entails a monitor's presence at a study site throughout the trial. The monitor reviews source documentation, including patient records, lab results, and investigational product dispensing logs, ensuring accuracy and compliance with study protocols and good clinical practices (GCP). Staff interviews verify proper adherence to trial procedures.

2. Centralized or Remote Monitoring in Clinical Trials: Centralized or remote monitoring allows sponsors to conduct clinical research monitoring without onsite visits. Leveraging technology like web portals and video conferencing, monitors remotely review data from multiple sites simultaneously. This method facilitates quick issue identification. Moreover, it enables proactive risk assessment before onsite visits, enhancing the efficiency of the monitoring process.

3. Types of Clinical Research Monitoring: Clinical research monitoring is a critical process that evaluates the quality and integrity of clinical trial data, ensuring adherence to regulatory requirements. Three primary methods are employed: onsite monitoring, centralized or remote monitoring, and risk-based approaches.

4. Risk-Based Approaches (2024): Embracing the advancements of 2024, risk-based approaches now leverage cutting-edge data analytics tools like advanced descriptive statistics and predictive algorithms. These tools identify potential trends or outliers in clinical trial data, signaling an increased risk of noncompliance with Good Clinical Practices (GCPs) or other regulations. Technology-driven approaches enable sponsors to detect issues earlier in a trial, allowing timely corrective action to prevent complications.

5. Benefits of Clinical Research Monitoring (2024): In the ever-evolving landscape of clinical research, effective monitoring strategies play a pivotal role in ensuring trials are conducted ethically, safely, and in accordance with protocol standards. Aligned with timelines agreed upon with regulatory authorities and budget constraints set by sponsors/CROs/investigators, these strategies provide invaluable insights. Acting as independent third parties, clinical research monitors offer objective perspectives across multiple sites, minimizing biases from investigators or personnel with vested interests.

Furthermore, contemporary monitoring ensures patient safety by overseeing the administration of drugs or medical devices and maintaining confidentiality throughout the study. Robust monitoring protocols also prove instrumental in reducing costs associated with potential delays, preventing errors throughout the trial duration, from pre-study startup to post-closeout when all enrolled patients have completed their participation.

Clinical Research Monitoring Guide

1. Mastering Clinical Research Monitoring in 2024:

Dive into the core of clinical research monitoring, a vital aspect of the research process ensuring both safety and result accuracy. Regular assessments of study sites verify proper data collection in adherence to ethical standards, legal requirements, and the latest Good Clinical Practice (GCP) guidelines.

2. Demystifying Monitored Study Types:

In the SEO landscape of 2024, clinical research monitoring extends beyond clinical trials to encompass observational studies, epidemiologic studies, and public health surveys. Understanding the specific study type being monitored is crucial for ensuring the correct procedures are implemented.

3. Navigating Study Site Monitoring:

Stay current with 2024 SEO standards by comprehending the intricacies of clinical research monitoring. The primary objective is meticulous confirmation that both protocol and informed consent forms are followed at each site. This involves in-depth reviews of relevant documents such as case report forms (CRFs), source documentation (e.g., physician notes), internal audit reports, and external quality assurance reports. Compliance with GCP guidelines during site visits or remote reviews, coupled with interviews assessing data collection and reporting processes, enhances the monitoring process.

4. Grasping Regulatory Requirements in 2024:

Beyond GCP guidelines, the SEO-friendly approach for 2024 emphasizes an awareness of applicable regulations from local governments or institutions. Adherence to these regulations is vital for compliance with laws related to clinical research monitoring activities.

5. Crafting an Advanced Monitoring Plan:

Elevate your monitoring plan in 2024 with a detailed timeline for site visits, specific focuses (e.g., patient enrollment/randomization, adverse event management), and strategies for auditing/reviewing generated data. Incorporate measures to control data collection risks, enabling early issue identification, aligning with SEO standards and ensuring a smooth study process.

Clinical Research Monitor Job

A Clinical Research Monitor plays a crucial role in ensuring the ethical and safe conduct of clinical trials while maintaining compliance with established standards. The primary focus is safeguarding the rights, safety, and well-being of human subjects participating in the trials. Responsibilities encompass a wide range of activities, including protocol development, coordination of study start-up, site visits, monitoring data accuracy and completeness, auditing files for regulatory compliance, managing investigator queries, preparing visit reports, reviewing protocol updates, resolving issues identified through audits, offering technical guidance to sites on protocol implementation, and escalating complex issues or potential risks.

Clinical Research Monitor Salary

The salary for this position varies based on factors such as education, experience, and geographical location. Entry-level positions may start at around $60,000 per year, while experienced professionals can earn up to approximately $90,000 per year. In addition to salary, many employers provide benefits such as paid vacation days, health insurance plans, and retirement packages.

Resources for Clinical Research Monitoring

1. National Institutes of Health (NIH): Clinical Research Monitoring

This link provides information on NIH's guidelines for monitoring clinical research, which include topics such as the roles and responsibilities of the investigator, data safety monitoring boards, and protocols for reporting unanticipated problems and adverse events.

2. National Institutes of Health (NIH): Guide to Clinical Research Monitoring

This comprehensive guide walks readers through all aspects of clinical research monitoring, including topics such as study design, randomization strategies, regulatory compliance requirements, data management, monitoring plans and reports, quality improvement initiatives, and safety assessments.

3. US Food and Drug Administration (FDA): Guidelines for Clinical Trials Monitoring

This resource from the FDA outlines the importance of effective monitoring in clinical trials and provides an overview of the different roles within a clinical trial as well as details about essential elements for implementation of an effective monitoring strategy such as risk assessments and adverse event tracking.

4. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

ICH has developed standards that provide a set of harmonized technical requirements for clinical trials conducted across countries in the European Union (EU), Japan, and US with an emphasis on quality assurance and safety monitoring during trials.

5. Association of Clinical Research Professionals (ACRP)

ACRP's guidelines provide best practice recommendations for conducting clinical research studies in accordance with applicable regulations and standards to ensure patient safety monitoring during studies as well as data integrity throughout the process from start to finish.

6. Pharmaceutical Research & Manufacturers of America (PhRMA)

The PhRMA guidelines provide an overview of expectations around clinical research activities with respect to ethics, data integrity, safety reporting, resource allocation and more. It defines roles and responsibilities of all those involved in overseeing a clinical trial such as a Clinical Research Monitor or CRA who has primary responsibility for ensuring that the protocol is implemented correctly throughout a study’s duration

Clinical Research Monitoring Review

1. What is the main purpose of clinical research monitoring?

A) To ensure that a research study is conducted in accordance with applicable regulations and ethical standards

B) To ensure that data collected during a research study is accurate and reliable

C) To evaluate the safety of participants enrolled in a research trial

D) To oversee the financial management of a research project

Answer: A) To ensure that a research study is conducted in accordance with applicable regulations and ethical standards. Clinical Research Monitors are responsible for ensuring compliance with Good Clinical Practice guidelines, protecting participant privacy, verifying data accuracy, and evaluating protocol deviations. In addition, they may also be involved in reviewing participant eligibility requirements, conducting site assessments, providing training to investigators and staff on proper study procedures, as well as monitoring progress towards completion of all requirements of the study.

2. What type of individuals typically serve as clinical research monitors?

A) Physicians

B) Nurses

C) Regulatory specialists

D) All of the above

Answer: D) All of the above. Clinical Research Monitors can come from various backgrounds such as medical doctors (MDs), nurses (RNs), pharmacists (RPhs), regulatory specialists (e.g., Regulatory Affairs Professionals or Paralegals), or biostatisticians/data analysts who have experience in clinical trials and understand local regulations related to human subject protection. Each monitor has specific job duties depending on their education and experience, such as assessing compliance with regulatory guidance or analyzing data sets for accuracy, completeness, integrity, or validity.

3. What kind of activities do clinical research monitors need to perform?

A) Protocol reviews or verifications

B) Ensuring appropriate documentation completion

C) Site visits to observe investigator conduct

D )All of the above

Answer: D )All of the above. Clinical Research Monitors need to perform several activities including protocol reviews or verifications; ensuring appropriate documentation completion; site visits to observe investigator conduct; liaising between sponsors and sites; assisting with resolving issues associated with adverse events; reviewing case report forms for completeness, accuracy, consistency and correctness; evaluating subject safety throughout enrollment process;and writing reports detailing their findings at each visit.

4. What is one benefit gained from having an effective Clinical Research Monitor on-site? A) Reduced risk for legal liability stemming from negligence

B) Improved protocol adherence by investigators

C) Increased patient engagement during trial period

D )All of the above

Answer: D) All of the above . An effective Clinical Research Monitor encompasses several benefits such as reduced risk for legal liability stemming from negligence due to thorough oversight and accurate record keeping; improved protocol adherence by investigators through continued communication between sponsor representatives and researchers on-site regarding best practices; increased patient engagement during trial period due to more detailed explanations about potential risks/benefits offered by having monitor on-site ; and improved efficiency when dealing with complex protocols that require multiple levelsof oversight due to familiarity with protocol specifics which decreases time spent troubleshooting errors or unclear instructions..

5. How often should Clinical Research Monitors visit a particular site?

A) Weekly B) Biweekly C) Monthly D) Quarterly

Answer: C) Monthly . It is recommended that Clinical Research Monitors visit sites at least once per month in order to maintain active surveillance over ongoing studies at each location while also providing timely feedback regarding any issues discovered while on-site visits are taking place within a shorter timeframe if needed based upon changes made midstream or other unanticipated circumstances which might require immediate attention by sponsor personnel.

Introduction to Clinical Trial Training

Have you ever wondered how new medications and treatments make it from the lab to your doctor's office? The answer lies in clinical trials, meticulously designed research studies that test the safety and effectiveness of new healthcare interventions on human volunteers.

If you're curious about this fascinating field and considering a career in clinical research, an introduction to clinical trial training is a perfect first step. This blog post will equip you with the foundational knowledge to jumpstart your journey.

Why the Rise in Clinical Research Training?

The field of clinical research has seen a significant rise in demand over recent years. The evolving landscape of the pharmaceutical and biotechnology industries, with a constant push for new and improved treatments, plays a significant role in this growth.

Clinical Research Associates: The Overseeing Force

A clinical research associate (CRA) is a crucial part of the clinical trial process. They act as the eyes and ears of the sponsor, overseeing the well-being of subjects and ensuring that the study adheres to strict regulatory guidelines. They are responsible for tasks like monitoring investigator sites, ensuring data integrity, and reporting any issues or deviations from the protocol. For those interested in becoming a CRA, consider this specialized CRA training course.

Benefits of Clinical Trial Training

With the clinical research market projected for continued growth, a thorough understanding of clinical research training is essential. Here's how it benefits you:

Equipping Yourself for a Rewarding Career: This training provides the necessary skills and knowledge to launch a successful career in clinical research. There are various specializations within the field, allowing you to tailor your path to your interests.

Contributing to Medical Advancements: By participating in clinical trials, you play a vital role in developing new treatments and improving patient care. The knowledge gained through training empowers you to be a valuable asset in this endeavor.

Strong Job Market Outlook: The demand for qualified clinical research professionals is high and expected to rise further. This training positions you to take advantage of this growing market.

What Does Clinical Trial Training Entail?

Clinical trial training equips individuals with the necessary understanding of:

The Clinical Research Process: From study design and participant recruitment to data collection and analysis, you'll gain insights into the entire lifecycle of a clinical trial.

Ethical Considerations: Protecting participant safety and well-being is paramount. Training emphasizes informed consent, patient confidentiality, and responsible research conduct.

Regulatory Requirements: Clinical trials adhere to strict guidelines set forth by regulatory bodies. Training ensures you understand these regulations and can navigate them effectively.

Specific Roles and Responsibilities: The clinical research team comprises various professionals, each with distinct duties. Training clarifies your role and how it contributes to the successful execution of the trial.

Who Should Consider Clinical Trial Training?

This training is valuable for anyone interested in a career in clinical research, including:

• Clinical research coordinators (Consider the Clinical Research Coordinator course)

• Data managers

• Clinical trial assistants (Explore the Clinical Trials Assistant Training)

• Regulatory affairs specialists

• Research nurses

• Physicians interested in research (Check out the Advanced Principal Investigator Physician Certification)

Where to Find Clinical Trial Training

There are numerous avenues to pursue clinical trial training. Here are some options to consider:

Online Courses: Several organizations offer introductory and advanced online courses in clinical research, including Pharmacovigilance Certification and ICH-GCP.

Universities and Colleges: Many academic institutions provide certificate programs or degrees in clinical research.

Professional Associations: Industry associations often host workshops and training programs specifically designed for clinical research professionals.

Begin Your Clinical Research Journey

By taking an introduction to clinical trial training, you'll unlock a world of possibilities in healthcare advancement. You'll gain the foundational knowledge to make informed decisions about your career path in this dynamic and ever-evolving field.

Remember, this is just the beginning! As you delve deeper, you'll discover the profound impact clinical trials have on improving human health and shaping the future of medicine.

I. Clinical Research Training: Background and Importance

Before diving into the specifics of clinical research training, it's necessary to understand what clinical research is and its importance in the field of medicine. Clinical research refers to the systematic study of potential new drugs, medical devices, and techniques to establish their safety and efficacy before they can be approved for use by regulatory authorities. In simple terms, clinical research aims to ensure that new treatments and therapies are both safe and effective for human use, protecting the public from potentially harmful side effects or complications.

Clinical research, thus, plays a key role in the process of bringing novel medical treatments to market. It is a multifaceted process that requires a range of skill sets, from data analysis to ethics and compliance. Clinical research associates (CRAs) are responsible for managing clinical trials and ensuring that they adhere to relevant laws and ethical guidelines. As such, clinical research training equips potential CRAs with the necessary skills to excel in their roles and contribute to the safe development of new therapies and medical products.

II. Components of Clinical Research Training

Clinical research training typically comprises several essential components, each designed to provide a comprehensive understanding of the clinical research process. Some of the critical elements of clinical research training include the following:

1. Basic Principles of Clinical Research: An overview of the fundamentals of clinical research, including the phases of clinical trials and the importance of randomization, blinding, and placebo controls.

2. Good Clinical Practice (GCP): A thorough understanding of GCP guidelines set by regulatory authorities like the International Council for Harmonisation (ICH) and the Food and Drug Administration (FDA) to ensure the safety, integrity, and quality of clinical trials.

3. Protocol Development: Training in the design and development of clinical trial protocols, with an emphasis on creating study objectives, inclusion/exclusion criteria, and the types of assessments required.

4. Ethics in Clinical Research: In-depth exploration of ethical considerations in clinical research, including informed consent, institutional review board (IRB) approval, and data protection.

5. Regulatory Compliance: Gaining a comprehensive understanding of the role of various regulatory authorities in the clinical research process, and ensuring compliance with relevant regulations.

6. Data Management and Biostatistics: Knowledge of essential data management techniques, including data collection and validation, data quality control, and the application of biostatistics in clinical research.

7. Clinical Trial Management: Training on the roles and responsibilities of the clinical trial team and best practices in trial management, including site selection, patient recruitment, and study closeout.

8. Safety Reporting and Pharmacovigilance: An understanding of safety reporting requirements and the importance of pharmacovigilance in maintaining patient safety throughout the clinical trial.

III. Clinical Research Training: Course Options and Certifications

Numerous clinical research training programs are available for those wishing to enter or advance within the clinical research field. These programs typically cater to diverse educational backgrounds and levels of expertise, ensuring that all prospective CRAs have access to the necessary training. Courses generally range from short-duration workshops to comprehensive diploma or degree programs.

One popular and widely recognized accreditation is the Clinical Research Associate (CRA) Certification. Obtaining this certification demonstrates a commitment to excellence and professionalism in clinical research. Several organizations offer clinical research associate certification online, making it an easily accessible option for many individuals.

In conclusion, clinical research training is essential for anyone wishing to pursue a career in clinical research. It equips learners with the skills and knowledge necessary to conduct and manage clinical trials, ensuring public safety and helping to bring life-enhancing treatments to market. With various course options available, including the Clinical Research Associate Certification Online, gaining the required qualifications is more accessible than ever before.

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.

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

Clinical Trial Monitoring Reports and How to Write Them

Among the most important aspects of study is observation. Overseeing the advancement of any stage, measure, process, and procedure in real time is essential to the accurate conclusion of any clinical trial undertaking. Normal monitoring actions are needed to guarantee caliber, efficiency, compliance within predefined and regulations fundamentals. In addition, it guarantees comprehensiveness, and precision within clinical investigation. Such actions also ensure that the trial isn't just conducted in compliance with Standard Operating Procedures (SOPs). They must also function to validate it is correctly reported and recorded. Consider enrolling in the Clinical Research Coordinator course or the CRA training provided by CCRPS.

There demands something vital as a part in the execution of trials. And this thing is known as trial development reports.

Such a report ought to be carefully prepared and it must summarize the means that a study is done. It also ought to point out recruiting progress and procedures; should emphasize and clarify adjustments to the analysis, and ought to point security issues. If you're involved in such reporting or need an in-depth understanding of the procedures, the Advanced Clinical Research Project Manager Certification might be of interest.

Aside from the ethics committee, researchers could also need to present yearly improvement reports of an investigation (such as any applicable alterations or dangers) to spouses, encouraging associations, and/or organizations, along with other interested parties if needed. To understand more about these requirements and get certified, the ICH-GCP course is an excellent resource.

If you're thinking about getting important skills on GCP or you also would like to upgrade your own know-how, subscribe to our comprehensive Good Clinical Practice class here.

In summary, tracking and reporting processes is an incredibly significant function in clinical trials. The right conduct of these procedures ensure compliance with legislation, regulations, and predetermined conditions. In addition, they make certain that the study doesn't pose any dangers to wellbeing. Progress reports, subsequently, empower practitioners, specialists, researchers, ethics committees, as well as others involved to keep a tab on the trial and its own advancement. Clinical professionals need to signal any alterations or risks to react to them timely, correctly, and efficiently. For further training, consider the Pharmacovigilance Certification to deepen your knowledge in monitoring drug safety.

The objective of progress reports would be to accumulate and outline upgrades, key facets, along with summaries of a continuing trial. It's very crucial to be aware that progress reports must be filed to institutional evaluation board/independent integrity questionnaire (IRB/IEC), following a trial that has obtained positive opinion.

One other important issue to mention is there are many different forms and when it comes to submitting progress reports that researchers must take into consideration before proceeding.

Precisely, these kinds are:

• Printing name and date of entry ought to be composed also. A digital copy is also needed to be delivered to the interested websites and committees inside a 30-day interval following the reporting procedure was completed.

• The period of time whereby an advance report ought to be filed is at least one time in a year. Nevertheless, based upon the situation as well as the RECs' needs, these reports might be passed in more often, although the analysis is still going and till its official conclusion date.

Take courses from CCRPS and learn more on how to become a clinical research professional. For detailed guidance on submission requirements and processes, the Medical Monitor Certification and Advanced Principal Investigator Physician Certification can provide extensive knowledge.

Discover more from Clinical Trials Assistant Training | Clinical Research Training | Certified Clinical Research Professionals Course to further your career in clinical research management.

2018 Clinical Research Associate (CRA) Salaries Estimated from 1,850 American Employees

Skills Alliance Clinical Research Associate - CRA Course

Clinical Research Associate Job available - CRA Course

$113,368 per year

Advanced Clinical Clinical Research Associate

Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).

Clinical Research Associate Job available

$107,750 per year

Syneos Health Commercial Solutions Clinical Research Associate

Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).

Clinical Research Associate Job available

$98,894 per year

Piper Companies Clinical Research Associate

Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).

Clinical Research Associate Job available

$101,820 per year

Novella Clinical Clinical Research Associate

Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).

Clinical Research Associate Job available

$97,659 per year

Covance Clinical Research Associate

Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).

Clinical Research Associate Job available

$96,667 per year

Premier Research Clinical Research Associate

Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).

Clinical Research Associate Job available

$95,178 per year

Syneos Health Clinical Clinical Research Associate

Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).

Clinical Research Associate Job available

$93,469 per year

PRA Health Sciences Clinical Research Associate

Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).

Clinical Research Associate Job available

$76,150 per year

Novo Nordisk, Inc. Clinical Research Associate

Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).

Clinical Research Associate Job available

$95,242 per year

PPD Clinical Research Associate

Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).

Clinical Research Associate Job available

$91,293 per year

IQVIA Clinical Research Associate - CRA Course

Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).

Clinical Research Associate Job available

$89,615 per year

Cyberonics Clinical Research Associate

Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).

Clinical Research Associate Job available

$87,000 per year

AbbVie Clinical Research Associate - CRA Course

Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).

Clinical Research Associate Job available

$81,391 per year

ICON plc Clinical Research Associate - CRA Course

Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).

Clinical Research Associate Job available

$79,110 per year

PAREXEL Clinical Research Associate - CRA Course

Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).

Clinical Research Associate Job available

$81,281 per year

QuintilesIMS Clinical Research Associate - CRA Course

11 salaries

Clinical Research Associate Job available

$72,749 per year

MD Anderson Cancer Center Clinical Research Associate - CRA Course

7 salaries

Clinical Research Associate Job available

$71,410 per year

Chiltern International Clinical Research Associate - CRA Course

5 salaries

$87,722 per year

Pharmanet Clinical Research Associate - CRA Course

5 salaries

$72,488 per year

Roche Clinical Research Associate - CRA Course

5 salaries

Clinical Research Associate Job available

$71,586 per year

University of Florida Clinical Research Associate - CRA Course

11 salaries

Clinical Research Associate Job available

$69,492 per year

Department of Veterans Affairs Clinical Research Associate - CRA Course

6 salaries

Clinical Research Associate Job available

$66,274 per year

Abbott Laboratories Clinical Research Associate - CRA Course

6 salaries

Clinical Research Associate Job available

$66,095 per year

University of Utah Clinical Research Associate - CRA Course

19 salaries

Clinical Research Associate Job available

$66,775 per year

University of Minnesota Clinical Research Associate - CRA Course

8 salaries

Clinical Research Associate Job available

$64,600 per year

University of Connecticut Health Center Clinical Research Associate - CRA Course

8 salaries

Clinical Research Associate Job available

$58,321 per year

St. Jude Children's Research Hospital Clinical Research Associate - CRA Course

6 salaries

Clinical Research Associate Job available

$56,315 per year

Northwestern University Clinical Research Associate - CRA Course

6 salaries

Clinical Research Associate Job available

$54,342 per year

Duke Clinical Research Institute Clinical Research Associate - CRA Course

5 salaries

$73,447 per year

Emory University Clinical Research Associate - CRA Course

5 salaries

Clinical Research Associate Job available - CRA Course

$50,778 per year

Medpace Clinical Research Associate

6 salaries

Clinical Research Associate Job available

$50,958 per year

University of South Florida Clinical Research Associate

20 salaries

Clinical Research Associate Job available

$50,810 per year

The University of Iowa Clinical Research Associate

26 salaries

Clinical Research Associate Job available

$43,547 per year

Yale University Clinical Research Associate

5 salaries

Clinical Research Associate Job available

$40,378 per year

University of Maryland, Baltimore Clinical Research Associate

7 salaries

Clinical Research Associate Job available

$39,818 per year

University of North Carolina at Chapel Hill Clinical Research Associate

7 salaries

Clinical Research Associate Job available

$38,402 per year

University of North Carolina at Greensboro Clinical Research Associate

5 salaries

Clinical Research Associate Job available

$38,475 per year

Virginia Commonwealth University Clinical Research Associate

19 salaries

Clinical Research Associate Job available

$36,453 per year

University of North Carolina Clinical Research Associate

15 salaries

$36,955 per year

University of Pittsburgh Clinical Research Associate

13 salaries

Clinical Research Associate Job available

$33,878 per year

SUNY Downstate Medical Center Clinical Research Associate

9 salaries

Clinical Research Associate Job available

$33,343 per year

Washington University in St. Louis Clinical Research Associate

18 salaries

Clinical Research Associate Job available

$15.75 per hour

UC San Diego Clinical Research Associate

19 salaries

Clinical Research Associate Job available

$4,353 per month

University of California - San Francisco Clinical Research Associate

6 salaries

Clinical Research Associate Job available

$100 per day

Real Staffing Clinical Research Associate

15 salaries

Clinical Research Associate Job available

$31.95 per hour

University of Nebraska Medical Center Clinical Research Associate

12 salaries

Clinical Research Associate Job available

$15.81 per hour

Texas Tech University Health Sciences Center Clinical Research Associate

6 salaries

Clinical Research Associate Job available

$3,609 per month

Aerotek Clinical Research Associate

8 salaries

$47.68 per hour

Randstad Clinical Research Associate

35 salaries

$45.90 per hour

Ohio State University Clinical Research Associate

124 salaries

Clinical Research Associate Job available

$14.49 per hour

University of Kentucky Clinical Research Associate

59 salaries

Clinical Research Associate Job available

$21.63 per hour

Biotech Partners Clinical Research Associate

12 salaries

Clinical Research Associate Job available

$111,431 per year

DOCS Global Clinical Research Associate

14 salaries

Clinical Research Associate Job available

$90,856 per year

CyberCoders Clinical Research Associate

28 salaries

$88,409 per year

Zp group Clinical Research Associate

18 salaries

$98,008 per year

CIG Clinical Research Associate

109 salaries

$116,784 per year

CorTech, LLC Clinical Research Associate

40 salaries

$38.91 per hour

Skills Alliance (Recruiting Company) Clinical Research Associate

12 salaries

$71.01 per hour

InfoStaff Clinical Research Associate

52 salaries

$109,699 per year

Stony Brook University Clinical Research Associate

5 salaries

Clinical Research Associate Job available

$39,254 per year

Brio Resource Group Clinical Research Associate

46 salaries

Clinical Research Associate Job available

$129,987 per year

Planet Pharma Clinical Research Associate

7 salaries

Clinical Research Associate Job available

$117,458 per year

biorasi LLC Clinical Research Associate

18 salaries

$63,702 per year

Intermountain Home Care Clinical Research Associate

11 salaries

$15.55 per hour

Piper Clinical Solutions Clinical Research Associate

16 salaries

$64,853 per year

Personify Clinical Research Associate

36 salaries

$99,373 per year

Segal Trials Clinical Research Associate

24 salaries

$2,195 per month

Bertram & Associates Clinical Research Associate

7 salaries

$116,417 per year

Lodestar Executive Search Clinical Research Associate

7 salaries

$116,417 per year

PSU Personnel Services Unlimited, Inc. Clinical Research Associate

6 salaries

$104,485 per year

The Hastings Group Clinical Research Associate

7 salaries

$116,417 per year

Ploeger Recruiting Services Clinical Research Associate

6 salaries

$104,485 per year

Phillips Staffing Solutions Clinical Research Associate

6 salaries

$104,485 per year

PMG Employment Consultants Clinical Research Associate

7 salaries

$116,417 per year

Bio-Partners Clinical Research Associate

7 salaries

$116,417 per year

Hire Horizons Clinical Research Associate

6 salaries

$104,485 per year

SearchStars Clinical Research Associate

6 salaries

$104,485 per year

Fowler Placement Services, Inc. Clinical Research Associate

6 salaries

$104,485 per year

Plastic Executive Recruiters Clinical Research Associate

6 salaries

$104,485 per year

EPM Scientific Clinical Research Associate

13 salaries

Clinical Research Associate Job available

$98,268 per year

Barrington James Clinical Research Associate

12 salaries

Clinical Research Associate Job available

$124,820 per year

MedExec International Clinical Research Associate

6 salaries

$104,485 per year

Tri-Force Clinical Research Associate

7 salaries

$116,417 per year

Professional Recruiting Partners, LLC Clinical Research Associate

7 salaries

$116,417 per year

Career Brokers, Inc. Clinical Research Associate

6 salaries

$104,485 per year

Helffrich International Clinical Research Associate

6 salaries

$104,485 per year

Tailored Management Clinical Research Associate

10 salaries

$79,138 per year

MJ Recruiters, LLC Clinical Research Associate

6 salaries

$104,485 per year

Meet Recruitment Clinical Research Associate

12 salaries

$102,820 per year

University of Virginia Clinical Research Associate

16 salaries

Clinical Research Associate Job available

$44,455 per year

Medical University of South Carolina Clinical Research Associate

20 salaries

Clinical Research Associate Job available

$32,233 per year

Oregon Health Sciences University Clinical Research Associate

17 salaries

Clinical Research Associate Job available

$43,176 per year

AutoPro Technical Recruiting Clinical Research Associate

6 salaries

$104,485 per year

MMS Group Clinical Research Associate

6 salaries

$104,485 per year

ONESource Technical Clinical Research Associate

6 salaries

$104,485 per year

Technology Recruiting Solutions, Inc. Clinical Research Associate

6 salaries

$104,485 per year

BRUNEL CANADA Clinical Research Associate

20 salaries

$83,573 per year

Affinity Executive Search Clinical Research Associate

20 salaries

$111,284 per year

PPD Development, L.P. Clinical Research Associate

11 salaries

$92,737 per year

HireNetworks Clinical Research Associate

12 salaries

Clinical Research Associate Job available

$94,478 per year

CMC Limited Clinical Research Associate

13 salaries

$111,719 per year

CMD And Associates Clinical Research Associate

17 salaries

$97,982 per year

fulltimeGiGS Clinical Research Associate

10 salaries

$120,496 per year

Cameron Craig Group Clinical Research Associate

17 salaries

$88,715 per year

Prevalent Group Clinical Research Associate

17 salaries

$95,522 per year

True North Consultants Clinical Research Associate

6 salaries

$104,485 per year

Financially Stable Pharmaceutical Clinical Research Associate

8 salaries

$112,472 per year

JDP Search Group Clinical Research Associate

16 salaries

$99,326 per year

PeopleStaff Clinical Research Associate

15 salaries

$84,270 per year

Clinical Management Consultants Clinical Research Associate

9 salaries

Clinical Research Associate Job available

$115,881 per year

JOHNLEONARD Clinical Research Associate

8 salaries

Clinical Research Associate Job available

$61,509 per year

Rangam Consultants Inc. Clinical Research Associate

5 salaries

Clinical Research Associate Job available

$72,617 per year

Keshav Consulting Solutions Clinical Research Associate

13 salaries

$60,670 per year

Onboard.jobs Clinical Research Associate

15 salaries

$94,156 per year

Cor-Tech LLC Clinical Research Associate

15 salaries

$42.97 per hour

Klinexa Inc. Clinical Research Associate

8 salaries

$25.00 per hour

Systematic business consulting Clinical Research Associate

13 salaries

$88,299 per year

University of Miami Miller School of Med Clinical Research Associate

8 salaries

$74,809 per year

Global Channel Management, Inc. Clinical Research Associate

12 salaries

$41.26 per hour

Productive Data Solutions, INC. Clinical Research Associate

8 salaries

Clinical Research Associate Job available

$27.00 per hour

Selective Staffing Solutions Clinical Research Associate

8 salaries

Clinical Research Associate Job available

$19.49 per hour

Atlanta Center for Medical Research Clinical Research Associate

5 salaries

$33,642 per year

DOCS Clinical Research Associate

10 salaries

$78.22 per hour

Impact Business Group Clinical Research Associate

12 salaries

$54.45 per hour

CPS Recruitment Clinical Research Associate

7 salaries

$28.46 per hour

SCOPE International USA, Inc. Clinical Research Associate

11 salaries

$80,886 per year

Interview with Center for Advanced Obstetrical Care and Research Clinical Research Associate

8 salaries

$17.00 per hour

Inflamax Research Inc. Clinical Research Associate

6 salaries

$2,900 per month

Priority Sales Recruiting Clinical Research Associate

11 salaries

$108,226 per year

University of Texas Medical Branch Clinical Research Associate

5 salaries

Clinical Research Associate Job available

$16.50 per hour

Eastern Virginia Medical School Clinical Research Associate

10 salaries

Clinical Research Associate Job available

$82,730 per year

Computech Corporation Clinical Research Associate

7 salaries

$45.00 per hour

Details on application Clinical Research Associate

9 salaries

$205,058 per year

BK Rich Associates Clinical Research Associate

6 salaries

$90,000 per year

Central Florida Careers Clinical Research Associate

9 salaries

$16.93 per hour

Chipton Ross Clinical Research Associate

10 salaries

$34.37 per hour

AppleOne Clinical Research Associate

10 salaries

$75,534 per year

Sabio Systems Clinical Research Associate

9 salaries

$19.90 per hour

Blair Search Clinical Research Associate

7 salaries

$116,417 per year

Sponsor Pharmaceutical company Clinical Research Associate

9 salaries

$110,000 per year

Helix Biomedics LLC Clinical Research Associate

6 salaries

$12.00 per hour

Ability Professional Network Clinical Research Associate

9 salaries

$95,663 per year

Leading CRO Company!! Clinical Research Associate

5 salaries

$99,504 per year

The Pursell Group Clinical Research Associate

7 salaries

$116,417 per year

PeaceHealth Clinical Research Associate

9 salaries

$35.36 per hour

new england physician recruitment center-boston Clinical Research Associate

9 salaries

$180,000 per year

MBA IT Consulting Services, Inc. Clinical Research Associate

7 salaries

$116,417 per year

Food Management Search Clinical Research Associate

7 salaries

$116,417 per year

Pharmaceutical Organization Clinical Research Associate

8 salaries

$246,884 per year

Texas Tech University Health Sciences Center of El Paso Clinical Research Associate

5 salaries

Clinical Research Associate Job available

$15.64 per hour

University of Wisconsin–Madison Clinical Research Associate

8 salaries

Clinical Research Associate Job available

$40,257 per year

Careers 2005 Clinical Research Associate

6 salaries

$104,485 per year

Taylee Staffing Clinical Research Associate

8 salaries

$102,227 per year

Rayco Technical Solutions, LLC Clinical Research Associate

6 salaries

$104,485 per year

Nishom Pharma Corp Clinical Research Associate

6 salaries

$70,000 per year

The Research Foundation for The State University of New York at Stony Brook Clinical Research Associate

5 salaries

$57,250 per year

Real Life Sciences Clinical Research Associate

7 salaries

$117,035 per year

Inflamax Research Clinical Research Associate

6 salaries

$2,900 per month

Aptude Inc. Clinical Research Associate

7 salaries

$20.00 per hour

Virginia Commonwealth University Clinical Research Associate

8 salaries

Clinical Research Associate Job available

$36,729 per year

Scientific Search Clinical Research Associate

7 salaries

Clinical Research Associate Job available

$85,322 per year

ER Squared, Inc. Clinical Research Associate

6 salaries

$50,000 per year

Valesta Clinical Research Solutions Clinical Research Associate

7 salaries

$65,000 per year

On-Board Services Clinical Research Associate

5 salaries

$38.67 per hour

Military4Hire Clinical Research Associate

6 salaries

$104,485 per year

SSC Clinical Research Associate

8 salaries

$115,000 per year

Enterprise Search Associates Clinical Research Associate

6 salaries

$104,485 per year

The Fountain Group Clinical Research Associate

8 salaries

$135,000 per year

VetPharm, Inc. Clinical Research Associate

8 salaries

$47,500 per year

Pioneer Data Systems, Inc. Clinical Research Associate

7 salaries

Clinical Research Associate Job available

$50.00 per hour

The University of Michigan Clinical Research Associate

6 salaries

Clinical Research Associate Job available

$60,183 per year

North Peak Recruiting Clinical Research Associate

6 salaries

$104,485 per year

MedicusTek USA, Inc Clinical Research Associate

7 salaries

$42,000 per year

Genesis Global Management Corporation Clinical Research Associate

7 salaries

$105,971 per year

Quality Clincial Research Clinical Research Associate

5 salaries

$28,802 per year

The Job Jobber Clinical Research Associate

7 salaries

$88,043 per year

IMARC Research, Inc. Clinical Research Associate

5 salaries

$15.52 per hour

PHAIDON INTERNATIONAL Clinical Research Associate

6 salaries

$109,198 per year

Experis Clinical Research Associate

7 salaries

$38.63 per hour

Sunrise Systems Clinical Research Associate

7 salaries

$29.69 per hour

Small Niche CRO! Clinical Research Associate

6 salaries

$88,364 per year

University of Toledo Clinical Research Associate

5 salaries

$66,079 per year

Resource Employment Solutions Clinical Research Associate

6 salaries

$24.04 per hour

RELODE Clinical Research Associate

6 salaries

$5,000 per month

Painter & Associates Personnel Clinical Research Associate

6 salaries

$104,485 per year

Provident Research Inc Clinical Research Associate

6 salaries

$113,374 per year

RBW Consulting Solutions Ltd Clinical Research Associate

5 salaries

$109,280 per year

ParkPower Corporation Clinical Research Associate

5 salaries

$120,496 per year

Acara Solutions Clinical Research Associate

5 salaries

$19.80 per hour

Essentia Health Clinical Research Associate

5 salaries

Clinical Research Associate Job available

$16.73 per hour

New York State Psychiatry Institute Clinical Research Associate

5 salaries

Clinical Research Associate Job available

$45,068 per year

BRIDGEWAY COMMERCE GROUP Clinical Research Associate

5 salaries

$120,496 per year

NuWest Group Clinical Research Associate

5 salaries

$16.43 per hour

Pharmaceutical Clients Clinical Research Associate

5 salaries

$30.00 per hour

Byrnes and Rupkey, Inc. Clinical Research Associate

5 salaries

$120,496 per year

Cap & Sol Clinical Research Associate

5 salaries

$50.00 per hour

RCTS, Inc Clinical Research Associate

5 salaries

$13.15 per hour

All US Jobs Clinical Research Associate

5 salaries

$120,000 per year

The DAVIS Companies Clinical Research Associate

5 salaries

$25.00 per hour

JGB BioPharma Consulting Inc. Clinical Research Associate

5 salaries

Clinical Research Associate Job available

$112,945 per year

Advanced Technology Solutions Clinical Research Associate

5 salaries

Clinical Research Associate Job available

$43.55 per hour

Worldwide Clinical Trials Holdings, Inc. Clinical Research Associate

5 salaries

$109,545 per year

Private Practice Leadership, LLC Clinical Research Associate

5 salaries

$15.71 per hour

Team1Medical Clinical Research Associate

5 salaries

$33,786 per year

ZEISS Group Clinical Research Associate

5 salaries

$48.00 per hour

Worldwide Placement Limited Clinical Research Associate

5 salaries

$90,000 per year

Pharmaceutical Research Associates, Inc. Clinical Research Associate

5 salaries

$76,530 per year

Healthcare Recruiters International Clinical Research Associate

5 salaries

$62,430 per year

Bridgeway Professionals Clinical Research Associate

5 salaries

$120,496 per year

i-Pharm Consulting Clinical Research Associate

5 salaries

Clinical Research Associate Job available

$94,767 per year

Collaborative Clinical Research Associate

5 salaries

$39.65 per hour

The Veritas Healthcare Solutions LLC Clinical Research Associate

5 salaries

$78,850 per year

Louis Stokes Cleveland VA Medical Center Clinical Research Associate

5 salaries

$43,399 per year

Piper Enterprise Solutions Clinical Research Associate

5 salaries

$111,929 per year

Groupware Solutions Clinical Research Associate - CRA Course

5 salaries

$30.00 per hour

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 to Prepare for a Clinical Research Interview

Preparing for almost any interview may be a stressful experience. When interviewing for clinical research positions, interviews pose a special challenge which may require extra preparation. Below are the following five suggestions to be certain you are correctly prepared for a medical study project interview.

Do your research

First, take a deep dive into a company’s current information, discoveries or updates. LinkedIn is a superb source to observe factors about the business and its workers. Through LinkedIn it is possible to study how long employees work there, their credentials, and their own histories.

In addition, examine the business’ site, take notes and search for any current media releases. Based on your potential situation, your interviewer may would like you to share your own understanding of search practices and suitable protocol. Assessing these practices and describing them will help you through the meeting. For instance, if you're interviewing for a pharmaceutical medical study endeavor, you should take a look at the pharmaceutical sector and any appropriate research that's been published lately.

Get your resume into tiptop shape

The top two aspects clinical research partners look for in a candidate are your qualifications and resume. Your resume functions as your profile, and is also an extension of you. If your resume isn't up-to-date, then you might lose out on chances for possible interviews.

Be certain that you write your credentials into your resume and concentrate on the particular job which you are interviewing for. Examine the job description along with their needs for tips about what info you need to elaborate on, but don't over embellish you achievements.

Print multiple copies of your resume and then maintain them at a professional folder or notebook. Summarize your expertise and goals into a quick elevator pitch, and you’re ready for the next step.

Questions and ANSWERS

Before you go into an interview, it is critical that you prepare for questions the employer might ask. As a exercise, we recommend printing out the exact work description of the job positing and taking a look at every requirement. With every demand, write a vital illustration of how you've had a direct or related experience. Have precise and succinct examples of real life adventures that will assist you to swiftly collect your ideas throughout the interview. This exercise can help you to get accustomed to the position and realize areas where you're a solid candidate.

For a clinical study project interview, your previous clinical study experience is remarkably significant. Be certain you are extremely confident with all the comprehensive information of your previous clinical and research endeavors. Your interviewer may want to ask you certain questions, and you ought to be well equipped to answer. Most importantly, your interviewer will probably ask you about issues that you faced and how you worked together with the remaining part of the study team. Be conscious of occasions when you overcame hardship or faced an obstacle.

In addition answering to their questions, you need to come up with some of your own. This will help demonstrate your interest in the company and position. These questions ought to be unique and should reveal you have completed a thoughtful analysis on company. Make sure these questions are genuine and show a real interest in the employers. However, steer clear of questions regarding benefits, time bonuses and off. These questions can make you to look as though you believe that a provider owes you something, even though this is not the case.

Review your previous research

Walking into a meeting unprepared is essentially requesting collapse and also a missed job prospect. Interview preparation may be tiring and stressful, but the rewards are immense. Simply take the aforementioned five measures seriously, and you're on your path to a thriving clinical study project interview.

Prior to your clinical study job interview, put aside a couple of hours to gather your ideas. To begin, make sure you know who you are meeting . Locate them via LinkedIn and learn a little more about them. After that you can examine their own career path and create rapport more easily.

As mentioned above, along with your resume, be certain you are completely honest throughout this meeting. The job market can be challenging and you might be tempted to embellish a little, but we strongly urge you against that. During your interview, you could be caught in a lie, therefore entirely destroying your odds or, worse, you might get hired and then you're not able to complete the tasks you promised to be experienced in.

Lastly, get certified to make a strong candidate through CCRP Course.

At CCRPS.org, we offer seven courses and certification trainings to give you an advantage. 82% of our students are hired within the first month of taking the course. We are accredited by the Accreditation Council For Clinical Research & Education (ACCRE) and tailor our course to you. For example we offer special courses for nurses and an accelerated certification + internship opportunity for anyone with minimal or no clinical experience.  

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.

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

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.

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

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.

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

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.

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