Quiz: Roles & Responsibilities

1

A principal investigator is required to comply with the Institutional Review Board (IRB) for:

A. Reporting protocol deviations or changes collectively once the study is closed.

B. Beginning a study based on a predetermined timeline by the study team, even if that is prior to IRB approval.

C. Hiring specific study staff based on social status.

D. Obtaining initial and continuing review approval at the start and during the course of a research study.

2

The staff at the research site may include:

A. Research Assistants.

B. Therapists/Counselors.

C. Principal Investigator.

D. All of the above.

E. None of the above.

3

Based on GCP, the Sponsor is responsible primarily for study design and management as well as _______________.

A. Research site submissions to the IRB.

B. Training staff that are not related to or involved in the study.

C. Participant safety.

D. Interference in the day-to-day operation of research sites.

E. Changing the site's institutional policies.

4

The 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.

5

If the Sponsor transfers all study related duties and functions to a clinical research organization (CRO), the Sponsor is no longer responsible for the conduct of the study.

A. TRUE

B. FALSE