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SOCRA CCRP Exam - Topic 1 Question 19 Discussion

Actual exam question for SOCRA's CCRP exam

Question #: 19
Topic #: 1

[All CCRP Questions]

A revised protocol added genomic testing to banked tissue samples. Before shipping samples, what must the site do?

AExecute material transfer agreement

BShip under dangerous goods requirements

CObtain IRB/IEC approval for revised protocol and ICF

DNotify enrolled subjects

Show Suggested Answer

Suggested Answer: C

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.

by Cherry at Jul 20, 2026, 08:33 AM

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