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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?

Show Suggested Answer Hide Answer
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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Shenika
3 days ago
I feel like B) Sponsor/investigator contracts are crucial too. They outline responsibilities.
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Glendora
8 days ago
I agree, but A) Occupations and affiliations of IRB members is also important for transparency.
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Alishia
14 days ago
I think it's C) Subject enrollment logs. They need to track who participated.
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Pearly
19 days ago
Wait, are we really keeping all those logs? Sounds like a lot of paperwork!
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Adelaide
24 days ago
I agree with C, but why would anyone keep B) Sponsor/investigator contracts after a trial?
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Brynn
29 days ago
I’m not so sure about D) Investigational product labels being retained. Seems unnecessary.
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Sabine
1 month ago
I think it’s A) Occupations and affiliations of IRB members. That’s important too!
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Elli
1 month ago
Definitely C) Subject enrollment logs. They’re crucial for tracking participants.
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Luther
1 month ago
I thought it was D) Investigational product labels, but I can't recall if those are required for retention after the trial.
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Bobbie
2 months ago
I feel like we had a practice question about this, and I chose B) Sponsor/investigator contracts. But now I'm second-guessing myself.
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Brande
2 months ago
I remember discussing the importance of documentation in our last review session. Could it be A) Occupations and affiliations of IRB members? That seems relevant.
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Tresa
2 months ago
I think the IRB needs to keep records related to subject safety, so maybe it's C) Subject enrollment logs? But I'm not entirely sure.
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