1Which agency or agencies oversee investigations of alleged research misconduct?

A. Food and Drug Administration

B. National Institutes of Health

C. Office of Research Integrity

D. Center for Drug Evaluation and Research

E. All of the above.

2Which of the following constitutes research misconduct according to federal regulations?

A. Fabrication of data.

B. Falsification of data.

C. Failure to protect human research subjects.

D. Plagiarsm.

E. A, B, and D

3Which of the following events is considered research misconduct?

A. Unintentional errors in data entry.

B. Differences of opinion.

C. Failure to protect human research subjects.

D. Authorship dispute not involving plagiarsm.

E. None of the above.

4Which one is NOT a goal of the regulations for dealing with research misconduct (42 CFR 50 subpart A)

A. To define research misconduct.

B. To define penalties for research misconduct.

C. To establish procedures for reporting and investigating research misconduct.

D. To protect both those who report alleged research misconduct.

E. To protect those accused of research misconduct.

5Choose the definition forPlagiarsm:

A. Making up data or results and recording or reporting them.

B. Changing the research record so that it does not accurately reflect the research findings.

C. Using another person's ideas, processes, results, or words without giving credit.

1Essential documents collected for research projects may be audited or inspected for GCP compliance by which stakeholder?

A. Financial audit agencies

B. Regulatory authorities

C. Quality Assurance monitors

D. B and C

2Which is the correct order of shortest record storage requirement to longest storage requirement?

A. HIPAA, NIH, FDA

B. NIH, HIPAA, FDA

C. FDA, HIPAA, NIH

D. FDA, NIH, HIPAA

E. NIH, FDA, HIPAA

3One (1) bottle of study medication containing 100 tablets was supplied to the research center. 55 tablets were ingested and 3 tablets were lost. How much study medication is on hand?

A. 42 tablets.

B. 45 tablets.

C. 97 tablets.

D. Amount unknown.

4Choose the statement that is true of Case Report Forms (CRFs).

A. Similar to progress notes, CRFs are never considered source documents.

B. According to GCP guidelines, CRFs may be printed, optical, or electronic documents, used for the collection of protocol-required information.

C. All research studies use electronic CRFs.

D. Investigators are never required to maintain CRFs according to the records retention schedule as defined in the Code of Federal Regulations.

5Source documents are records created during a trial for data collection and can be related to participants medical treatment and history.

A. TRUE

B. FALSE

1The Principal Investigator retains ultimate responsibility for the conduct of the study even if specific tasks are delegated to other staff members.

A. TRUE

B. FALSE

2The Sponsor is responsible for:

A. Implementing and maintaining quality assurance and quality control systems.

B. Ensuring that the study is conducted and documented in compliance with the protocol and GCP.

C. Ensuring that the study is conducted and documented in compliance with regulatory requirements.

D. All of the above.

3According to GCP, who is responsible for all study-related medical decisions?

A. Study Coordinator

B. Pharmacist

C. Qualified physician

D. Phlebotomist

4The Sponsor may contract with an organization to handle trial-related responsibilities as:

A. Specified in writing.

B. Agreed upon verbally but in writing is not required.

C. Defined in a Transfer of Regulatory Obligations (TORO) or other contractual documentation.

D. A and C.

5In the conduct of a research study, central roles include which of the following:

A. Intern

B. Sponsor.

C. Principal Investigator.

D. B and C.

1There are two major elements involved in recruitment:

• Defining the right study population; and
• Recruiting participants appropriately and ethically.

A. TRUE

B. FALSE

2Which of the following are elements of a successful recruitment plan?A. Avoiding unnecessarily restrictive inclusion and exclusion criteria in the protocol.

B. Identifying a recruiting strategy during protocol development.

C. Adequately reimbursing participants for their time and expenses without being coercively generous.

D. All of the above.

3The Belmont Report of 1979 established which key principals of human research protections:

A. Respect, justice, and honor.

B. Justice, search for truth, and respect.

C. Honor, humanity, and cause no harm.

D. Respect for persons, beneficence, and justice.

4Study teams may use incentives for study participation; however, careful consideration should be given to avoid ___________.

A. Inducement

B. Rewards

C. Coercion

D. Free medical care

E. A and C

F. B and D

5Which group must approve recruitment and retention materials for any federally funded research prior to utilization in a clinical study?A. Administrative Research Board

B. Institutional Review Board

C. International Conference on Harmonisation

D. Ethical Advisory Committee

1If a protocol change is needed to eliminate an apparent immediate hazard to study participants, this should only be implemented after:

A. Notifying the FDA via a protocol amendment.

B. Notifying the IRB.

C. A and B.

D. A change to eliminate an apparent immediate hazard should be implemented immediately.

2The holder of the IND application, usually the company, institution or investigator who submitted the application, is called the _____ of the IND.

A. Sponsor

B. Monitor

C. Study Physician

D. Partner

3The sponsor must wait _____ calendar days after IND submission before initiating research activities in support of an Investigational New Drug application (IND).

A. 7

B. 15

C. 30

D. 60

4An unexpected death of a subject while participating in a clinical trial which is considered possibly related to the drug being tested should be reported to the FDA:

A. As soon as possible but no later than 7 days after notification of the event.

B. As soon as possible but no later than 15 days after notification of the event.

C. Only in the annual report.

D. Only in the final study report.

5If a study is exempt from IND requirements, then monitoring of the safety of participants on the study is not required.A. TRUE

B. FALSE