clinical research certification exam questions

SOCRA CCRP Practice Exam

Prepare effectively for the SOCRA CCRP exam with our Practice Exam Quiz. SOCRA stands for Society of Clinical Research Associates, and CCRP denotes Certified Clinical Research Professional. This quiz is designed to simulate the real exam experience and assess your readiness. It covers essential topics in clinical research, making it ideal for individuals seeking certification or professionals looking to reinforce their knowledge. Test your understanding, identify areas for improvement, and boost your confidence with our comprehensive quiz. Whether you're a novice or experienced professional, this quiz will help you achieve success in the field of clinical research.

SOCRA CCRP Practice Exam Questions and Answers

*the responsibility for ensuring that the investigator understands a clinical trial lies with:.

Sponsor

Coordinator

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*What is the minimum number of IRB members?

*significant risk device is defined as an investigational device that is:.

Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject.

Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to the health, safety, or welfare of a subject.

For a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject.

All the above

*With respect to IRB/IEC membership, both the FDA and the ICH require that

A majority of the members' primary area of interest is in a scientific area

At least one member holds a Ph.D. degree or equivalent

At least one member's primary area of interest is in a nonscientific area

A majority of the members are from or have ties to the institution of record

*In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval?

The investigator provides his/her written approval

The study drug has an FDA approved marketing application

The FDA provides written approval of the IND

Subjects cannot be enrolled until IRB/IEC approval has been obtained

*A subject has been enrolled on a study and was randomized to the non-treatment arm. The protocol outlines study procedures for all subjects to be performed within one week of enrollment. Which of the following statements about this case is correct?

This subject does not need to undergo any of the study procedures since the subject is enrolled on the non-treatment arm

This subject should undergo all study procedures as outlined in the protocol

This subject only needs to undergo the study procedures that pertain specifically to the subject

This subject can undergo the study procedures whenever it is convenient

*A purpose of monitoring clinical trials is to verify that:

The rights, safety, and well-being of human subjects are protected

Investigators receive adequate payment for their participation in the clinical trial

The investigator has received annual reports from the sponsor

The regulatory agency has received all case history information of subjects enrolled on the clinical trial

*Which of the following is the proper way to make a correction to a CRF?

Completely blacken the incorrect entry and then enter the correct information

Back date the corrected entry with the date of the original entry

Initial using the initials of the sponsor’s representative who reviewed the change

Add the initials of the person making the change, the date of the change, and, if necessary, a brief explanation of the change

The objective of the ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

The contents of a protocol should generally contain:.

Trial objectives and purpose

Assessment of efficacy

Data handling and record keeping

All of the above

Only A & C

Only the principal investigator is allowed to transcribe data from the source document to the CRF?

When a short form is used for informed consent, the witness must sign either the short form or the summary., form___________ is the investigator statement., what is 45 cfr part 46.

HHS - Protection of Human Subjects

FDA - Protection of Human Subjects

HHS - Protection of Children

HHS - Protection of Research Participants

The Code of Federal Regulations that applies to Investigational New Drug Applications is 21CFR812.

Who monitors the progress of all clinical trial investigations being conducted under an ind.

Principal Investigator

The World Medical Association (WMA) ethical principles for medical research involving human subjects is called...

The Belmont Report

The National Research Act

The Nuremberg Code

The Declaration of Helsinki

The international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects is known as...

Good Clinical Practices (GCP)

The Declaration of Helsinki

Fundamental Ethical Principles (FEP)

The Code of Federal Regulations that applies to Institutional Review Boards is:

This form is used for the voluntary reporting of adverse events and product problems: , each irb that reviews studies involving children as subjects is covered by:.

21CFR 56, Subpart A

21CFR 56, Subpart B

21CFR 50, Subpart D

21CFR 56, Subpart C

This form is used for the mandatory reporting of serious adverse events:

What is covered in 21cfr50 subpart b.

Informed consent of Human Subjects

IRB Functions and Operations

Records and Reports

Additional Safeguards for Children in Clinical Investigations

*The IRB must determine that requirements for permission by parents or guardians and assent by children are met.

What topic is covered in 45cfr46 subpart b.

Additional Safeguards and Protections

Additional Protection for Prisoners and Vulnerable Subjects

Additional Protection for Children and Unborn Fetuses

Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research

The clinical investigator will update the financial disclosure information if any relevant changes occur during the investigation's course and for _______ following the study's completion.

2 years

5 years

The 3 fundamental ethical principles for human subjects' in research are:

Respect for persons, beneficence, justice

Respect for subjects, their safety and their time

Respect for sponsor, IRB and FDA guidelines

Respect for data, welfare and discovery

*Each IRB that uses an expedited review procedure must adopt a method for keeping all members advised of research proposals which have been approved under the expedited review procedure _________.

45 CFR 46.110; CFR 56.110(c)

45 CFR 46.110(d); 21 CFR 56.110

45 CFR 46.110(c); 21 CFR 56.110(c)

45 CFR 46.110(b); 21 CFR 56.110(c)

*In general, an AE observed during the conduct of a study should be considered an unanticipated problem involving risk to human subjects, and reported to the IRB, only if it were _________.

Would have implications for the conduct of the study

A, B & C

Once the sponsor evaluates data from a clinical trial and decides the drug presents an immeasurable and significant risk to the subjects; the sponsor has _____________ to discontinue the study.

A short form informed consent is a written summary of the icf that is not to exceed one page., identify the manner in which the informed consent form (icf) can be presented to the subject..

ICF can be read to the subject of the LAR

ICF is handed to the subject to read and sign on their own in private

ICF is delivered via FedEx with a return stamped envelope

ICF must be delivered to the subject or LAR electronically with a read receipt requested

When using the short form informed consent, the witness and the person actually obtaining the consent from the subject shall each sign the short form in addition to the summary.

Per 21 cfr part 312, the sponsor must notify fda and all participating investigators in an ind safety report within 15 calendar days after the sponsor determines that the information qualifies for reporting. , during the clinical trial, regulations require that a subject be given the right to....

Travel

Withdraw at any time

Get financial compensation

Speak to a sponsors attorney

Which signatures are required by FDA regulation to be on the consent form?

The investigator

The subject

The investigator and the suject

The subject and a witness

According to 21 CFR 312.56, if a sponsor finds an investigator is non-compliant with a clinical protocol or approved investigational plan, the sponsor must:

Report the investigator to the IRB once it becomes aware

Bring the investigator into compliance

Immediately close that investigators site

None of the above

Minimal risk is defined as "the magnitude of harm that a subject would encounter is not exceeded by those ordinarily encountered in daily life".

In accordance with regulations, before implementation, the informed consent document must be approved by the:.

Investigator

A, B & C

B & C only

Proper preparations should be made and adequate facilities provided to protect the experimental subject against even the remotest possibility of

Injury and hospitalization

Financial hardship

Injury, disability or death

After completion of the investigation, sponsor shall provide the investigator with a final report.

Per 21 cfr part 312, who is required to sign a 1572 statement of investigator form.

The coordinator

The investigator and the coordinator

Anyone substantially involved in the study

A request to export an investigational drug from the U.S. must include

The quantity of drug to be shipped per shipment and the frequency of expected shipments.

Adequate information about the drug to satisfy the FDA that the drug is appropriate for the proposed investigational use in animals.

A statement that the drug will be used for investigational purposes only and that the drug may be legally used by that consignee in the importing country for the proposed use.

A & C only

FDA may waive any of the requirements contained in the regulations, including the requirements for IRB review.

The code of federal regulations part 50, 56 and 312 (among others) are designed to ensure the safety of clinical testing and the safety of products following a marketing approval., the food and drug adminisrtation (fda) conducts drug risk assessment by considering which of the following.

There are a sufficient number of people needing the drug.

The benefits of the drug outweigh the known and potential risk of the drug

The side-effects of the drug is measurable

The sponsor is able to financially support the research

An investigational drug can be exported from the U.S., if

Permission is granted by Congress

The intended recipient is a US pharmacy

The importer is a foreign pharmacy inspected and approved by the FDA

Approval is granted after a written request is submitted to the FDAs International Affairs Staff Associate Commissioner.

The drug is for investigational use only and goes directly to a potential patient

Emergency use of a test article is exempt from the requirement for IRB review, provided that such emergency use is reported to the IRB in writing within 5 calendar days.

A clinical hold is an order by fda to the investigator to suspend or stop ongoing investigations., an ind is always required before using an investigational new drug..

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Certification Guides

Career guides, interviews & features, clinical research certification - ccra, ccrc, cpi, search for schools.

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Gaining a clinical research certification can offer many benefits for those in the field. Earning a credential through a rigorous application review and test indicates to potential employers that the holder boasts specific experience and skills making him or her more likely to succeed in a given occupation.

In the case of clinical research, this is especially important since running clinical trials requires hands-on training and continued guidance to ensure compliance with long-established standards.

These clinical research professionals include varied roles, including clinical research associates (CRA), clinical research coordinators (CRC), and principal investigators (PI).

In sum, having a certification in one of these areas can provide the following advantages:

Enhances Professionalism – Certified clinical researchers and investigators can take their career to a more professional level by:

Becoming well-grounded in a core body of knowledge defined by the certifying body
Committing to the pursuit of knowledge in their area of expertise through ongoing professional development
Gaining certification through assessment signifying they possess the knowledge and skills necessary to lead in their field
Committing to follow a code of ethics as defined by the certifying body

Indicates Competence – Through certification, an applicant’s knowledge and skills as a qualified, ethical clinical researcher are validated by a third party. Certification verifies an understanding of international clinical research standards and the ability to apply those standards to the researcher’s profession.

Applies Quality Standards to the Profession – Certified clinical researchers commit to the protection of human subjects, compliance with research regulations, and the quality of the data they collect.

Sets a Professional Apart from Others – Researchers who gain certification show their commitment to quality, ethics, and international research standards which sets them apart from those without certification. Clinical research certifications prepare researchers for career advancement and greater responsibility as leaders in their field.

Can increase Salary – Certified clinical researchers also have the potential to earn more than their non-certified colleagues.

Arizona State University

Johns hopkins university (aap), university of west florida, become a certified clinical research associate (ccra).

Certifying Agency: The Association of Clinical Research Professionals (ACRP)

Eligibility Requirements: Applicants must attest to having at least 3,000 hours of work experience performing the tasks and knowledge of the content areas of the CCRA exam. Experience older than ten years will not be considered. See below for exam content details.

Up to 1,500 hours of work experience may be substituted for one of the following options:

Current ACRP-CP, CCRC, CCRA, and CPI Designation OR
Graduate from a clinical research education program accredited by the Council on Higher Education Accreditation (CHEA)

All applicants undergo a formal eligibility review process upon application.

Exam Details: The exam assesses proficiency in six core knowledge areas including:

Candidates must show they can apply that knowledge to their professional responsibilities. Applicants can download a Detailed Content Outline (DCO) and a CCRA Exam Handbook from the CRA Certification page under “About the Exam”.

Exam Format: 125 multiple-choice questions that test knowledge based on memory, application, and analysis of information
Exam Duration: Maximum of three hours
Exam Delivery: Secure computer terminals
Exam Language: English
Exam Fees: Total exam fees range from $435 to $600 depending on ACRP membership status and when applicants apply for the exam (early-bird or regular). This includes an application fee and an exam fee. Note that all non-members will receive one year of ACRP membership upon passing the exam.
Exam Dates: Spring 2024 Exam Dates: February 15 to May 15, 2024; Fall 2024 Exam Dates: July 15 to October 15, 2024

Renewal Process: According to the Maintenance of Certification Program through ACRP, certified individuals must participate in 24 contact hours or points of continuing education and activities every two years. Alternatively, they may retake the certification exam.

Careers for CRAs: Clinical research associates are employed by sponsors from pharmaceutical companies, device companies, grant companies, universities, sponsoring physicians, or other entities. They serve in the role of an independent monitor in the administration and progression of clinical trials on behalf of the sponsor. CRA certification can advance a career as a:

Clinical Research Associate
Research Nurse
Independent Consultant/Contractor

Become a Certified Clinical Research Coordinator (CCRC)

Eligibility Requirements: Applicants must attest to having at least 3,000 hours of work experience performing the tasks and knowledge of the content areas of the CCRC exam. Experience older than ten years will not be considered. See below for exam content details.

Examinees must show they can apply that knowledge to their professional responsibilities. Applicants can download a Detailed Content Outline (DCO) and a CCRC Exam Handbook from the CRC Certification page under “About the Exam”.

Exam Fees: Total exam fees range from $435 to $600 depending on ACRP membership status as well as when applicants apply for the exam (early-bird or regular). This includes an application fee and an exam fee. Note that all non-members will receive one year of ACRP membership upon passing the exam.

Careers for CRCs: Clinical research coordinators are employed by clinical research organizations under the direction of a principal investigator, who practices research under GCP guidelines. CRP certification can advance a career as a:

Clinical Research Coordinator

Become a Certified Principal Investigator (CPI)

All CPI candidates must also provide proof of employment as a principal investigator (PI) or sub-investigator (sub-I) on two clinical trials.

Up to 1,500 hours of work experience and one clinical study PI or sub-I position may be substituted for one of the following options:

Examinees must show they can apply that knowledge to their professional responsibilities. Applicants can download a Detailed Content Outline (DCO) and a CPI Exam Handbook from the PI Certification page under “About the Exam”.

Renewal Process: According to the Maintenance of Certification Program through ACRP, certified individuals may take the current certification exam or they must participate in 24 contact hours or points of continuing education and activities every two years.

Careers for CPIs: Principal Investigators hold a PhD or equivalent and are responsible for the ethical and safe conduct of clinical trials. CPI certification can advance a career as a Principal Investigator.

Become a Certified Clinical Research Professional (CCRP)

Certifying Agency: The Society of Clinical Research Associates (SOCRA)

Eligibility Requirements: Applicants must be working under Good Clinical Practice (GCP) guidelines and must meet one of the three following criteria sets:

Two years of experience as a full-time clinical research professional or 3,500 hours of part-time experience during the last five years
Associate, undergraduate, or graduate degree in clinical research and has a minimum of one year of full-time experience or 1,750 hours of part-time experience during the past two years as a clinical research professional
Undergraduate or graduate certificate in clinical research with no less than 12 semester credit hours or totaling 144 credit hours from an academic institution of higher learning; an associate or bachelor’s degree in a pharmacy, science, health science, or related field; and a minimum of one year of full-time experience or 1,750 hours of part-time experience during the past two years as a clinical research professional

Applicants must submit an application, resume/CV, job description, verification of employment letter, and signed ethics statement.

Exam Details: The exam focuses on five content areas patterned after the 2017 SOCRA Job/Task Analysis. Examinees can download a detailed exam outline . Generally, candidates are tested on ethical principles, safety, informed consent; clinical trial protocol and amendments; institutional review board/ethics committee roles and responsibilities; investigator roles and responsibilities; and sponsor roles and responsibilities.

Exam Format: 130 multiple-choice questions that assess understanding and application, 30 of which are beta testers and are not scored. Examinees must answer 72 of the 100 scored questions correctly to gain certification.
Exam Duration: Maximum of four hours
Exam Delivery: Paper and pencil format or computer-based testing
Paper/Pencil (Members: $395, non-members: $450)
Computer-Based Testing (Members: $395 + $115 within North America, +$175 outside North America, non-members: $450 + $115 within North America, +$175 outside North America)
Exam Dates: Paper and pencil format dates run throughout the year in various locations. Computer-based testing is determined once the application is approved.

Renewal Process: Certification is valid for three years and must be renewed by application . CCRPs must complete 45 hours/credits of continuing education during this period, 22 of which must be related to clinical research. The other 23 hours may concern the professional’s specific career path. The fee to renew is $350.

Careers for CCRPs: Because clinical research professionals come from various professional paths, CRP certification can help advance careers in medical technology, nursing, statistics, biology, teaching, health records, administration, pharmacy, and other careers.

Become a Certified Research Administrator (CRA), Certified Pre-Award Research Administrator (CPRA), or Certified Financial Research Administrator (CFRA)

Certifying Agency: The Research Administrators Certification Council (RACC)

Eligibility Requirements: Candidates must comply with one of the following criteria sets:

Holds a bachelor’s degree and has three years of experience in research or sponsored programs administration from a sponsor/recipient organization or from a self-funded organization OR
Holds an associate’s degree and has five years of experience in research or sponsored programs administration from a sponsor/recipient organization or from a self-funded organization OR
Has six years of professional experience in research or sponsored programs administration from a sponsor/recipient organization or from a self-funded organization; candidates falling into this category must complete a petition application including two letters of reference

The third option is only available through a special petition process and each petition is evaluated on a case-by-case basis.

Exam Details: The questions for each type of exam are obtained from previously certified individuals in those fields (CRA, CPRA, and CFRA). Exam sections consist of varying topics depending on the certification and include some of the following: project development and administration, legal requirements, research partnership and funding, project costs, fiscal compliance, and more.

Exam Format: CRA (200 multiple choice questions); CPRA (250 multiple choice questions); CFRA (200 multiple choice questions)
Exam Delivery: Computer-based testing at certified PSI testing facilities
Exam Fees: $395
CRA: Spring – May 11 to May 25, 2024; Fall – November 2 to November 16, 2024
CPRA: Spring – February 17 to March 2, 2024; Fall – August 17 to August 31, 2024
CFRA: Spring – March 2 to March 16, 2024; Fall – September 7 to September 21, 2024

Tests are administered Monday through Saturday during the outlined two-week exam windows at various PSI locations throughout the U.S. and Canada.

Renewal Process: Certification is valid for five years. Renewal for another five years follows these requirements:

CRA recertification requirements include 80 hours of continuing education, either taken or taught, or activities participated in, and three questions for use on a future certification exam. Educational activities include a variety of options as defined by RACC.
CPRA recertification requirements include 80 hours of continuing education, 80 percent of which must be related to pre-award activities; or by retaking and successfully passing the CPRA exam.
CFRA recertification requirements include 80 hours of continuing education, 80 percent of which must be related specifically to financial activities; or by retaking and successfully passing the CFRA exam.

Become a Certified Clinical Data Manager (CCDM)

Certifying Agency: The Society for Clinical Data Management (SCDM)

Eligibility Requirements: Applicants must meet one of the four following criteria sets:

Holds a bachelor’s degree or higher and has a minimum of two years of full-time clinical data management experience
Holds an associate’s degree and has a minimum of three years of full-time clinical data management experience
Has four or more years of full-time clinical data management experience
Has part-time work experience that equals or surpasses the full-time experience requirement

Applicants must submit an application as well as a CV.

Exam Details: The exam seeks to establish a universal standard of education, experience, and knowledge by which certified individuals would be recognized in the profession of clinical data management.

Exam Format: 130 multiple-choice questions that assess competence and expertise in the field of clinical data management
Exam Duration: Maximum of 3.5 hours
Exam Delivery: Online, computer-based exams at testing centers
Exam Fees: Exam fees range from $125 to $325 depending on membership and country of origin. There is a reduced fee for retaking the test within one year
Exam Dates: Exams are scheduled through Prolydian and are proctored virtually, so there is no need to travel to a testing site.

Renewal Process: Renewal fees range from $60 to $150 depending on membership and country of origin. Certification is valid for three years. CCDMs must obtain 18 continuing education units (CEUs) within three years, 60 percent of which must be directly related to clinical data management training.

Career Enhancement for CCDMs: Clinical data management professionals can enhance their career through certification by validating a specific skill set and knowledge that certifies them as experts in their field and shows the ability to mentor and prepare others for certification as a CDM.

Certification can benefit organizations because by hiring CCDMs, the company ensures best practices, efficiency, improved quality, comprehensive knowledge, excellence in the field, and a commitment of employees to professional development.

Learn More About Clinical Research Certification

Clinical research professionals wishing to learn more about clinical research certification can take a free online course offered by The National Institutes of Health . Topics covered by the course include:

Roles and responsibilities of the investigator and the institution
Regulatory issues
Ethical issues involved in human subjects research
Clinical investigators and the mass media

This course is offered 24 hours a day online and offers an exam at the end. Attendees who gain a score of 75 percent or higher on the exam will receive a certificate that verifies that the participant has gained an overview of the information presented in the course.

With her passion for uncovering the latest innovations and trends, Kimmy Gustafson has provided valuable insights and has interviewed experts to provide readers with the latest information in the rapidly evolving field of medical technology since 2019. Kimmy has been a freelance writer for more than a decade, writing hundreds of articles on a wide variety of topics such as startups, nonprofits, healthcare, kiteboarding, the outdoors, and higher education. She is passionate about seeing the world and has traveled to over 27 countries. She holds a bachelor’s degree in journalism from the University of Oregon. When not working she can be found outdoors, parenting, kiteboarding, or cooking.

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CRA Exam Questions

$40,000 If 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. $50,000 An 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. $100,000 An anti-lobbying certification is required on federal grants, cooperative agreements, and contracts exceeding a MINIMUM of4. $165,000 An 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 opportunities What happens to a proposal if it isn't funded?7. 2 NIH limits how many resubmissions on proposals?8. 2 CFR 215 OMB A-110 Administration Regulation for Education Institutes, Hospitals, and Non profits9. 2 CFR 220, OMB Circular A-21 Deals 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-87 Cost 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 agreements b. Administrative requirements for grants and cooperate agreements12. 3 years from submission of final report of expenditures Recipients of federal grant funds must retain records for a MINIMUM of13. 5 members An IRB is required to have at least:14. 6-9 months The 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. 90 Under 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 days If final financial reporting (FS 425 Report) to federal agencies is not completed with in the typical ___ days, the institution is out of compliance18. 90 days When 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 days How many days do recipients of federal grants funds have to submits final reports after completion of the project?

20. A-102 State and local governments are subject to which of the following OMB Circulars?21. Abstract Should 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 Negotiate When 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 Amendment c. 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 institution d. Member unaffiliated with the institution25. Acquisition of property or services A procurement contract is used for the purpose of26. Administrative requirements for grants and cooperative agreements only 2 CFR 215, OMB Circular A-110 provides regulations governing which of the following for educational institutions?27. Adobe What is required to use Grants.gov28. advise student to apply to the federal agency to request a proposal 90 days after proposal was submitted If 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 cost A cost that can be assigned to a project or an activity based on the relative benefits received30. allowable only if approved by the sponsoring agency According to OMB Circular A-21, costs incurred prior to the project start date are:31. All vertebrate animals The Federal Animal Welfare Act applies to which of the following animal species32. Annually If 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 1986 Which 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. 10,000,000 a. $100,00035. approval of student's embassy In 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 manner Which 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 conditions A Notice of Award typically includes which of the following

39. Basic and containment procedures designed to protect personnel and the environment Which of the following best describes essential laboratory biosafety levels in medical research?40. Bayh-Dole Act Which of the following was enacted as a uniform patent policy among the many federal agencies that fund research?41. Bequests A 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 workshop 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?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 department The Office for Human Research Protection is administered by45. A career development program An employee in a position which does not enable realization of full potential would benefit most from46. cash flow statement An important tool you may use to measure and track the flow of cash into and out of your operation47. Certifications and representations Just-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 category Which of the following changes does not require prior National Science Foundation approval?49. Change Order A 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 Research Who appoints the chair for each committees at universities

51. A citation of the contract clause authorizing the termination Which 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 Agreement Which 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 Regulations The following provides information on patent rights and responsibilities currently applicable to universities and federally sponsored projects54. cognizant agency A 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 Daily Which of the following sources is not commonly used for federal funding opportunities?56. Compliance approvals Retention of which records are required by the OMB57. Contact legal, then contact program officer over concerns If 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 extension Which 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 Act This 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 Commerce In 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. Copyright In which of the following areas of intellectual property is the concept of work-for-hire germane64. Cost Accounting Standards It 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 COLA granted to employees based in a foreign city, where cost of living is higher than in Washington, D.C.67. Cost Principals for Educational Institutes Who is the 2 CRF 220, OMB Circular A-21 for68. A cost reimbursement sub agreement Requires 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 contributions a. 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 Requirement No 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 Share Applicant 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 rules Which of the following is included in 2 CFR 215, OMB Circular A-110?74. Default and convenience Two critical termination clauses of the General Provisions of a federal contract75. Department of Agriculture Which agencies is responsible for administering the Animal Welfare Act?76. Department of Energy Which of the following agencies does NOT fund health science research77. Director of Human Resource Who should administer progressive discipline to an employee?78. the Director of the institution's animal care As 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 year OMB 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 use d. 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 administration a. internal controls82. electronic funds transfer The 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 value Is allowable as cost sharing85. Established fundamental national policy for the environment and established the council on environmental quality What is the National Environmental Policy Act?86. Evaluation Plan It is important to define carefully and exactly how success will be determined.

87. E-Verify FAR 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 years How often do approved animal protocols need to be reviewed by the Institutional Animal Care and Use Committee (IACUC)89. Executive Branch branch 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 $181,500 NIH Salary cap is at what percentage?91. Executive Level I, II, III What is the highest level of salary?92. Executive Orders 8248 and 11541 Establishing 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 Authorities Delegates 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. Fabrication Making 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 expenses a. 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 company Conflict 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 preparation d. 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. Falsification Manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record102. FAR In order for a contractor to be awarded a federal contract, he must comply with the provisions set forth by:103. FAR The 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 agency b. cognizant agency105. Federal commons What 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 investigator a. Rebudgeting107. Federal Financial Assistance Management Improvement Act 1999 Public Law 106-107 The 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 checks c. electronic funds transfer109. Federal regulations governing the use of humans in research Always require full informed consent of the subject or the subject's guardian110. The first $25,000 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 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 license b. one copy of the official archives113. Formulation of the President's Budget; Action by the Congress; Presentation (to Congress) and-Execution of enacted budget laws What 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 funding Under 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 housing a. teaching abroad117. Goals/Objectives/SOW/Implementation Applicant should explain the expected results and benefits of each objectives.118. House of Representatives a 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 number You 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. 120 c. 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 years d. Every 3 years122. How to do business internationally The 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. iEdison Interagency 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 proposal d. 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 body a. 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 review b. 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. indemnity One 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 system Upon 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 embassy a. 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 years b. twice a year134. Institutional Biosafety Committee Which of the following is mandated for the oversight of research involving recombinant DNA

135. Institutional National Research Service Awards The 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 project The individual authorized by the Board of Trustees to sign on behalf of the institution137. Institutions, Investigators Who is covered by the COI regulation138. Institutions that have more than $25,000,000 in federal grants or contracts Which of the following would be required to file a disclosure statement (DS-2) with the federal government?139. internal controls Efficient 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 Firearms b. U.S. Department of State141. In the credentials box Where 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 contractor a. 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. $75,000 d. $75,000 $50,000 X 1.50 = $75,000144. Involves a conflict of interest Faculty 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 filed What 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 contract Which of the following best describes a fixed-price contract150. It is a public-private partnership Which 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 Branch Courts 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 investigator c. certification and representations154. Land acquisition In a Construction Grant, which is allowable155. Law passed to protect certain species of marine mammals deemed as being in danger of extinction What is the Marine Mammal Protection Act?156. Legislative Branch Article 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 submit If a federal agency requires a PI to submit online, what should be done158. Letter of support A 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 only The 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 applicant Under federal Equal Employment Opportunity provisions, a supervisor should NOT ask which of the following during an employment interview:163. Material Safety Data Sheet (MSDS) file Which of the following is essential to a Chemical Hygiene Plan?164. Material Transfer Agreement MTA165. 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 Agreements Recommended 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 committee c. responsible administrative official of the organization

169. Member unaffiliated with the institution According 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 conditions The Walsh-Healey Public Contracts Act deals with issues on171. Modified total direct cost Is 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 applications In 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 Awards d. Institutional National Research Service Awards174. National Library of Medicine Which 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 months b. 6-9 months176. Needs/Problem statement It 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 awards Research 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-Time Refers 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 Agreement A 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 continuation b. Award terms and conditions181. Nuclear Regulatory Commission Standards for handling radioactive materials are developed and monitored by the182. October 1 The federal fiscal year begins:183. The Office and Grants and Contracts/Finance will monitor and draw cash on expenditures as appropriate The 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 department d. a cabinet-level department

185. Office supplies, postage, administrative and clerical salaries, local telephone charges and general purpose equipment The 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-133 The 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 basis The 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 subjects Which of the following costs is allowable according to OMB Circular A-21?192. personnel salaries are increased Prior 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 only a. live, vertebrate animals only194. Plagiarism The appropriation of another person's ideas, processes, results, or words without giving appropriate credit195. A plan for expenditure of funds Which of the following must be included in every federal grant budget?196. Possible items could NIH request through Just-in-time Other 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 agreement To provide assistance with substantial involvement of the federal agency198. prior actual cost A 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 made b. personnel salaries are increased200. Prior intramural support should be addressed in the narrative When applying for extramural support, in which of the following ways should the principal investigator address prior related intramural support?201. Prisoners Which 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 1974 When 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 travel Which 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 Solicitation RFP 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 unpublished What 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 assistance What 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 animals Each organization using animals in Public Health Service sponsored projects must provide written assurance of its compliance with215. Rebudgeting Federal expanded authorities permit which of the following without additional sponsored approval?

216. received from any funding source Cost 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 expenditure d. 3 years from submission of final report of expenditure219. Refer employee to appropriate institution representative Which of the following is an appropriate response to sexual harassment reported by an employee in the work force?220. Regular dissemination of funding opportunities Which 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 limitation What 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 institution Under federal grant conditions, the title to equipment must223. Rent Which would you charge against F&A?224. Rental or usage fees from equipment purchased with grant funds Which of the following is considered program income?

225. Request a one year, no cost extension of the grant while a revised continuation is under preparation A 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 website What 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 awarded What is Truth in Negotiations Act?229. Research misconduct What is defined as fabrication, falsification and plagiarism, and does not include honest error or differences of opinion230. responsible administrative official of the organization Members 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 programs What is the Hatch Act?233. Returned to the sponsoring agency Upon completion of a federal grant, excess funds remaining in the account should be

234. RFP Which 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 personnel Proper 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 Office Providing 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 license For copyrighted works which result from federally sponsored activities, the federal government usually requires238. Salaries and wages Which 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. SF269 The following is used to prepare quarterly, semi-annual, annual, or end reports241. SF270 The following is used to request for an advance or reimbursement242. SF272 The following is used to prepare a report of federal cash transactions243. Shelby Amendment Access to federally funded research data is required under the244. Should be closely followed Which of the following is most appropriate use of federal agency guidelines for writing a proposal245. Sponsor Which 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 Administration a. 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-133 b. A-102248. Subcontractor only In the event of a cost overrun by a subcontractor, who would be held responsible by the funding source?249. Subcontractor's normal rate Which of the following establishes the actual facilities and administrative cost (indirect cost) rate for a subcontract?250. Subcontract, Subgrant, or Subagreement A 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 TOA A legally binding document authorizing work and appropriating funds as a supplement to a basic contact.

253. teaching abroad The Fulbright Program provides opportunities for254. Teaming Agreement An agreement between two or more parties to participate in a research project or teaching activity255. Temporary rate subject to final negotiation Which of the following best describes a provisional indirect cost rate256. They upload it to their submission application. Not on the SF 424 form If a PI wants to request a reviewer to a proposal submission, where can they do this257. Title It should tell us in 25 words or less what you intend to research and should be relevant258. Travel Which 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 project A 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 review 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 be261. True UBMTA may not be usable for materials in projects supported by industry. True or False262. True A one-time no-cost extension up to 12 months is allowed as an expanded authority. True or False263. twice a year The 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 contract a. 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 entity b. 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 grants c. 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 Award An 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 Security a 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 Affairs is 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 present A facilities and administrative cost (indirect cost) may be a direct cost if273. Untimely performance Under 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 grant a. 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 system d. individual accounts in an approved accounting system276. U.S. Department of Justice, under the False Claims Act Which federal agency is responsible for prosecuting institutional violations of effort reporting277. U.S. Department of State International 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 expenses b. Break refreshments at a project-sponsored workshop279. Varies with funding source Federal regulations require that documentation of expenditures must be kept for how long?280. verifiable from records Cost sharing must be

281. A vivarium What is an area, usually enclosed, for keeping and raising animals or plants for observation or research282. What are allowable costs Are 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 Institution Expedite 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 Significant Funds 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 purpose is 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 Force DOD 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 reporting The 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 under improves access to healthcare for people who are uninsured, isolated, or medically vulnerable and under DHHS.

300. What is Lobbying the 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 Act Requires 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 Act It 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 match At 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 important train 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 Act What 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 exception It'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 narrative d. 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 $25,000 b. The first $25,000322. Whenever covered animals are involved in a protocol Which 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 days c. 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 Authority a. 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 Foundation d. 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 Animals b. 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 confirm b. 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 hospitals c. 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 risks b. 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 Regulations a. 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 agency c. 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 $25,000 b. 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 notice d. 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 contract d. 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 services c. 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 costs c. 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 diem a. 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 agency d. 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 inspection a. 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 nonprofits b. 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 Health a. 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 Committee c. 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 file b. 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 positive b. 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 animals c. 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 Assistance b. The Foundation Directory

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CCRC EXAM QUESTION BANK: ACRP CERTIFICATION

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CCRC EXAM QUESTION BANK: ACRP CERTIFICATION

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ISBN-10 1691921408
ISBN-13 978-1691921409
Publication date September 13, 2019
Language English
Dimensions 8.5 x 0.46 x 11 inches
Print length 184 pages
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Publisher ‏ : ‎ Independently published (September 13, 2019)
Language ‏ : ‎ English
Paperback ‏ : ‎ 184 pages
ISBN-10 ‏ : ‎ 1691921408
ISBN-13 ‏ : ‎ 978-1691921409
Item Weight ‏ : ‎ 1.06 pounds
Dimensions ‏ : ‎ 8.5 x 0.46 x 11 inches
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Candidate Eligibility

SOCRA offers one comprehensive clinical research certification so there is no need to obtain multiple certifications when you transition to varying roles in the clinical research arena. Available to all persons working in clinical research: SOCRA members enjoy reduced certification fees, while non-members receive complimentary SOCRA membership upon passing the exam. Whether you are independent or affiliated with a research institution, or you're an investigator, coordinator, monitor, nurse, or any other role – SOCRA's CCRP is your credential of excellence.

Eligibility Criteria

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

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

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 [email protected]

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.

Hold a degree in "Clinical Research conducted with humans according to the principles of Good Clinical Practice GCP" 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
Hold an Undergraduate or Graduate Certificate in “Clinical Research conducted with humans according to the principles of Good Clinical Practice GCP" 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 .

Certification

Program Overview
CCRP Certification Quick Facts
Definition of a Clinical Research Professional
Certification Program Policies
Removal of CCRP® Credential
Verify Certification
Exam Overview
Application and Fee
Computer Based Testing Exams
Paper and Pencil Exams
Refunds, Rescheduling and Retesting
SOCRA Sponsored Exam Schedule
Preparing for the Exam
Preparation Resources
Examination Results
Host an Exam at Your Site
Apply Online
Exam Schedule SOCRA Sponsored Sites
Requirements for Maintaining Certification
Continuing Education Requirements
Descriptions of Acceptable CE
CE Recordkeeping Requirements
Request for SOCRA CE for Courses / Workshops
Installment Plan Payment
Renewal of Certification
Recertification Audit
Recertification Learning Module
Accreditation

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GCP Training & Certification : Clinical Research Society (CRS)

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COMMENTS

Certification Exam Practice Exercise
ACRP Exam Practice Exercise questions are aligned with the Detailed Content Outline (DCO) for each ACRP Certification exam. Each exercise contains 50 exam-specific multiple-choice questions and their corresponding answers. All questions cover at least one of six content areas of the exam, and all questions have previously appeared on a real ...
PDF Certified Clinical Research Associate (CCRA ) Examination Detailed
of certification programs. The Academy of Clinical Research Professionals (the Acad emy) develops the CCRA exam using certification industry best practices, as aligned with the NCCA Standards for Accreditation of Certification Programs. In following these best practices, the Academy conducts a Job Analysis Study every five (5) years to
Certified Clinical Research Associate Exam Study Guide
1. The rights and well-being of human subjects are protected. 2. The reported trial data are accurate, complete, and verifiable from source documents. 3. The conduct of the trial is in compliance with the currently approved protocol/amendment (s), with GCP, and with applicable regulatory requirements.
CCRP Certification Exam Overview
The Certification Examination has been developed by the SOCRA Certification Committee and SOCRA Certified Clinical Research Professionals (CCRPs®) who have demonstrated expertise in the development, management, and administration of clinical trials. These clinical research subject-matter experts (SMEs) come from diverse backgrounds and job ...
Preparation Resources
Once a candidate's certification application has been approved, a complimentary electronic copy of the certification program reference manual will be sent. The purpose of the reference manual is to help you prepare for the Examination. It is a resource to assist you with your preparation however; it is not an all-inclusive resource.
CCRP Certification Program Overview
The SOCRA Certified Clinical Research Professional (CCRP) program is your gateway to excellence in clinical research. Elevate your career with our internationally recognized certification, tailored for professionals dedicated to upholding the highest standards in the field. Join a community committed to ethical practices, continuous learning ...
SOCRA CCRP Practice Exam
Prepare effectively for the SOCRA CCRP exam with our Practice Exam Quiz. SOCRA stands for Society of Clinical Research Associates, and CCRP denotes Certified Clinical Research Professional. This quiz is designed to simulate the real exam experience and assess your readiness. It covers essential topics in clinical research, making it ideal for individuals seeking certification or professionals ...
CCRP SOCRA Exam
Practice Test #1 (Ethics, 21 CFR Parts 50, 56, 312, 812; 45 CFR Part 46) Past questions directly from SOCRA.
Certified Clinical Research Professional (CCRP) Exam
Study period plus one year. Study with Quizlet and memorize flashcards containing terms like When isn't an IND application needed?, What information must the general IND include? (21 CFR Part 312.23), How many days after FDA receives IND submission does the IND go into effect? (21 CFR 312.40) and more.
Guide to Clinical Research Certification
Exam Format: 125 multiple-choice questions that test knowledge based on memory, application, and analysis of information; Exam Duration: ... Clinical research professionals wishing to learn more about clinical research certification can take a free online course offered by The National Institutes of Health. Topics covered by the course include:
Preparing for the Exam
a. Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject. b. Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to the health, safety, or welfare of a subject. c.
PDF Certification Program Reference Manual
diversity of a clinical research professional's scope of activity The test questions are designed to be straightforward and easily understood. The questions are reviewed for fairness and readability by experts in test question development. The Certification Examination is evaluated and updated at least annually in order to assure that content is
CRA Exam Questions
Nov 11. $40,000 If 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. $50,000 An investigator on a NIH grant has permission to rebudget $50,000 in supply monies into equipment.
CCRC EXAM QUESTION BANK: ACRP CERTIFICATION
The CCRC (Certified Clinical Research Coordinator) Exam Question Bank contains 500 practice questions. The CCRC Question Bank is a companion volume to the CCRC Exam Study Guide. While the exam workbook contains questions on various topics the study guide provides the didactic material that underlies the questions. For effective exam preparation ...
Clinical Research Coordinator Exam Flashcards
Statement of Investigator; signed by the investigator to inform the FDA where the study is being done, who the PI is and who is helping them conduct the study, location of study, and what labs, and which IRB is being used. IND Safety Report. A proposal through which a sponsor obtains FDA approval of its plans to test a new drug in human trials.
Exam Outline
The examination content outline provides a detailed description of the content areas including topic areas and knowledge domains. Each question on the exam is based on the content outline. To prepare for the exam, a candidate should study the detailed outline and consider the knowledge, skills, and abilities needed to perform the duties of a CRP.
Clinical Research: Help & Review Final Exam
Clinical Research: Help & Review Final Exam. Free Practice Test Instructions: Choose your answer to the question and click "Continue" to see how you did. Then click 'Next Question' to answer the ...
PDF Certified Clinical Research Coordinator (CCRC ) Examination ...
of certification programs. The Academy of Clinical Research Professionals (the Acad emy) develops the CCRC exam using certification industry best practices, as aligned with the NCCA Standards for Accreditation of Certification Programs. In following these best practices, the Academy conducts a Job Analysis Study every five (5) years to
CCRP Certification: Candidate Eligibility Criteria
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 ...