SOCRA CCRP Exam - Topic 2 Question 14 Discussion

Actual exam question for SOCRA's CCRP exam

Question #: 14
Topic #: 2

An investigator received an updated investigator's brochure from the sponsor; the update did not include changes related to subject safety. Which of the following parties, if any, is the investigator required to notify?

AThe IRB/IEC

BThe Data Safety Monitoring Board (DSMB)

CThe regulatory authority

DNo notification is required

Show Suggested Answer

Suggested Answer: D

The Investigator's Brochure (IB) is updated by the sponsor to reflect new scientific or clinical information.

ICH E6(R2) 7.3: ''The sponsor should revise the IB as soon as new, significant information becomes available.''

ICH E6(R2) 4.1.5: Requires the investigator to ensure staff are informed, but there is no requirement to notify IRB/IEC unless subject safety, rights, or risk profile is affected.

Since this update contained no changes related to subject safety, the investigator is not obligated to notify IRB/IEC, DSMB, or regulators. The updated IB must simply be filed in the regulatory binder and implemented at the site.

Thus, the correct answer is D (No notification is required).

ICH E6(R2), 7.3 (Updating the Investigator's Brochure).

ICH E6(R2), 4.1.5 (Investigator responsibilities for informing staff).

by Kathryn at May 03, 2026, 02:11 AM

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2 months ago

I remember discussing how updates to the investigator's brochure usually require notifying the IRB, but I'm not sure if safety changes are the only reason to notify them.

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