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SOCRA CCRP Exam - Topic 2 Question 12 Discussion

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?
C) The IRB/IEC
A) Sub-investigators
B) Participants in long-term follow-up
D) No notification is required

SOCRA CCRP Exam - Topic 2 Question 12 Discussion

Actual exam question for SOCRA's CCRP exam
Question #: 12
Topic #: 2
[All CCRP Questions]

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?

Show Suggested Answer Hide Answer
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.


by Fletcher at Apr 02, 2026, 09:48 PM

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Doyle
2 hours ago
I think the investigator should notify the IRB/IEC first. They need to approve any changes.
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Hollis
5 days ago
I thought participants should be notified too, though.
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Carmelina
10 days ago
Seems like a no-brainer to inform the IRB first.
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Cheryll
16 days ago
Wait, why would they need to notify anyone if the study's closed?
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Casey
2 months ago
Totally agree, it's all about compliance!
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Lorean
2 months ago
Gotta notify the IRB/IEC first, right?
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Jackie
3 months ago
I’m a bit confused. If the study is closed to enrollment, does that change who needs to be notified? I thought it was just the IRB.
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Edmond
3 months ago
This seems similar to a practice question we did about protocol amendments. I feel like the IRB is usually the first point of contact.
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Kandis
3 months ago
I'm not entirely sure, but I remember something about keeping participants informed. Wouldn't they need to be notified too?
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Truman
3 months ago
I think the investigator should notify the IRB/IEC first since they oversee the ethical aspects of the study.
upvoted 0 times
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