Discuss SOCRA CCRP Exam Topic 2 Question 12

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?

ASub-investigators

BParticipants in long-term follow-up

CThe IRB/IEC

DNo notification is required

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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12 comments · newest first

Albina 3 months ago

True, but since it's closed to enrollment, the IRB/IEC is the priority. They oversee the study's compliance.

Lachelle 3 months ago

I agree, but what about the participants? They should know about the radiation imaging.

Doyle 3 months ago

I think the investigator should notify the IRB/IEC first. They need to approve any changes.

Hollis 3 months ago

I thought participants should be notified too, though.

Carmelina 3 months ago

Seems like a no-brainer to inform the IRB first.

Cheryll 4 months ago

Wait, why would they need to notify anyone if the study's closed?

Casey 5 months ago

Totally agree, it's all about compliance!

Lorean 5 months ago

Gotta notify the IRB/IEC first, right?

Jackie 6 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.

Edmond 6 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.

Kandis 6 months ago

I'm not entirely sure, but I remember something about keeping participants informed. Wouldn't they need to be notified too?

Truman 6 months ago

I think the investigator should notify the IRB/IEC first since they oversee the ethical aspects of the study.

SOCRA CCRP Exam - Topic 2 Question 12 Discussion