SOCRA Updated CCRP Exam Questions and Answers by kaden

Recruitment materials must be reviewed to protect subjects from misleading or coercive messaging.

21 CFR 56.111(a)(3):IRBs must ensure equitable subject selection.

ICH E6(R2) 3.1.2:IRBs safeguard rights, safety, and well-being, including review of recruitment strategies.

FDA and OHRP do not approve recruitment materials; responsibility lies withIRB/IEC.

Even if a study does not involve drugs, devices, or biologics, it still involveshuman subjectsand therefore requiresethical review by an IRB/IEC.

45 CFR 46.109(a):“An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy.”

ICH E6(R2) 3.1.2:“The IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects.”

Quality-of-life (QOL) studies may involve surveys, interviews, or questionnaires, but since they involve human participants, they are subject to human research protection regulations. FDA involvement is not required unless drugs or devices are tested. Similarly, HHS approval is not required unless the study is federally funded.

Thus, the correct answer isC (The IRB/IEC).

The investigator holds ultimate responsibility for all data reported.

ICH E6(R2) 4.9.1:“The investigator is responsible for the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor on the CRFs and all required reports.”

Monitors (D) verify data accuracy but are not responsible for data quality. Quality specialists (B) and IRB staff (C) have no role in data entry.

Correct answer:A (The clinical investigator).

ICH requiresimmediatereporting of all SAEs to the sponsor (except those protocol-identified as not requiring immediate reporting). Exact extract:

ICH E6(R2) 4.11.1: “The investigatorshould report all serious adverse events immediately to the sponsorexcept for those SAEs that the protocol… identifies as not needing immediate reporting.”Therefore, “Immediately” (A) is correct. The other timeframes are not aligned with ICH GCP for initial SAE notification from investigator to sponsor.