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SOCRA CCRP Exam - Topic 2 Question 12 Discussion
Actual exam question for
SOCRA's
CCRP exam
Question #: 12
Topic #: 2
[All CCRP Questions]
Topic #: 2
An investigator received an updated informed consent form (ICF) from the sponsor for a study closed to enrollment. Subjects are only in long-term follow-up. The change related to frequent radiation imaging at screening, with no change to drug safety profile. Who must the investigator notify first?
Suggested Answer:
C
21 CFR 56.109(a): IRBs must review all changes to informed consent before implementation.
ICH E6(R2) 4.8.2: If new information could affect willingness to continue, consent forms must be revised and approved by the IRB.
Even though screening is closed, the IRB/IEC must review the updated form before any subject re-consenting.
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