SOCRA CCRP Exam - Topic 2 Question 12 Discussion

Actual exam question for SOCRA's CCRP exam

Question #: 12
Topic #: 2

An investigator received an updated informed consent form (ICF) from the sponsor for a study closed to enrollment. Subjects are only in long-term follow-up. The change related to frequent radiation imaging at screening, with no change to drug safety profile. Who must the investigator notify first?

ASub-investigators

BParticipants in long-term follow-up

CThe IRB/IEC

DNo notification is required

Show Suggested Answer

Suggested Answer: C

21 CFR 56.109(a): IRBs must review all changes to informed consent before implementation.

ICH E6(R2) 4.8.2: If new information could affect willingness to continue, consent forms must be revised and approved by the IRB.

Even though screening is closed, the IRB/IEC must review the updated form before any subject re-consenting.

by Fletcher at Apr 02, 2026, 09:48 PM

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2 months ago

I think the investigator should notify the IRB/IEC first since they oversee the ethical aspects of the study.

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