SOCRA CCRP Exam - Topic 2 Question 14 Discussion

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).