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SOCRA CCRP Exam - Topic 1 Question 17 Discussion

After completion of a Phase III trial, which document should IRB/IEC retain?
A) Occupations and affiliations of IRB members
B) Sponsor/investigator contracts
C) Subject enrollment logs
D) Investigational product labels

SOCRA CCRP Exam - Topic 1 Question 17 Discussion

Actual exam question for SOCRA's CCRP exam
Question #: 17
Topic #: 1
[All CCRP Questions]

After completion of a Phase III trial, which document should IRB/IEC retain?

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Suggested Answer: A

21 CFR 56.115(a)(5): IRBs must retain records of IRB membership (names, qualifications, affiliations, occupations).

Other documents (contracts, enrollment logs, product labels) are site or sponsor responsibilities, not IRB's.


by Horace at Jun 20, 2026, 06:54 PM

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