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After completion of a Phase III trial, which document should IRB/IEC retain?
Suggested Answer: A
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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.
12 comments · newest first
SH
Shenika
2 months ago
I feel like B) Sponsor/investigator contracts are crucial too. They outline responsibilities.
GL
Glendora
2 months ago
I agree, but A) Occupations and affiliations of IRB members is also important for transparency.
AL
Alishia
2 months ago
I think it's C) Subject enrollment logs. They need to track who participated.
PE
Pearly
2 months ago
Wait, are we really keeping all those logs? Sounds like a lot of paperwork!
AD
Adelaide
2 months ago
I agree with C, but why would anyone keep B) Sponsor/investigator contracts after a trial?
BR
Brynn
2 months ago
I’m not so sure about D) Investigational product labels being retained. Seems unnecessary.
SA
Sabine
3 months ago
I think it’s A) Occupations and affiliations of IRB members. That’s important too!
EL
Elli
3 months ago
Definitely C) Subject enrollment logs. They’re crucial for tracking participants.
LU
Luther
3 months ago
I thought it was D) Investigational product labels, but I can't recall if those are required for retention after the trial.
BO
Bobbie
3 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.
BR
Brande
3 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.
TR
Tresa
4 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.