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A revised protocol added genomic testing to banked tissue samples. Before shipping samples, what must the site do?
Suggested Answer: C
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21 CFR 56.109(a): IRB must review and approve any protocol amendments before implementation.
ICH E6(R2) 4.5.2: Changes affecting subjects (e.g., genomic testing) require IRB/IEC approval and updated consent.
Thus, site must first obtain IRB approval for revised protocol and ICF.
12 comments · newest first
DO
Dorinda
1 month ago
I feel like D is necessary too. Subjects should be informed about changes.
LA
Lashandra
1 month ago
Agreed, but A is also important. Material transfer agreement is crucial.
MA
Maxima
1 month ago
I think it's C. We need IRB approval first.
MI
Miss
2 months ago
Material transfer agreement is crucial, can't skip that!
OD
Odelia
2 months ago
Wait, do we really need to do all that? Seems excessive.
PE
Pearly
2 months ago
I thought shipping under dangerous goods was a must?
MA
Mammie
2 months ago
Definitely need to notify the subjects too.
KE
Kenny
2 months ago
Gotta get that IRB approval first!
LO
Louisa
2 months ago
I definitely remember discussing the need for IRB/IEC approval in class, so I'm leaning towards C being the correct answer.
IL
Ilene
3 months ago
I feel like notifying enrolled subjects is important, but I can't recall if it's a requirement before shipping. Maybe it's D?
KR
Kristeen
3 months ago
I remember a practice question about shipping samples, and I think we had to consider the material transfer agreement too. Could it be A?
SH
Shawna
3 months ago
I think we might need to get IRB approval for the revised protocol, but I'm not entirely sure if that's the only step we need to take.