SOCRA CCRP Exam With Confidence Using Practice Dumps

Investigators are required to maintain accurate subject records, often referred to ascase histories.

21 CFR 312.62(b):“An investigator shall prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation.”

ICH E6(R2) 4.9.0:Reinforces that investigators are responsible for recording, handling, and storing clinical trial data.

Incorrect options:

B: Investigators may present protocols but cannot vote on IRB approval.

C: Sponsor responsibility (ICH E6 §5.18).

D: Sponsors are responsible for IB updates (ICH E6 §7.3.1).

Correct answer:A.

IRBs/IECs must retain records to permit evaluation of compliance.

ICH E6(R2) 3.4.2:“IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for at least3 years after completion of the trial.”

Extended retention (B–D) may occur institutionally, but ICH minimum is3 years.

Correct answer:A (At least 3 years).

The IB must be updatedas new significant safety information emerges.

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

ICH E2A:Requires sponsors to reportSuspected Unexpected Serious Adverse Reactions (SUSARs)in expedited reports and include them inIB updates or addenda.

A SUSAR report (B) represents new, unexpected, and serious safety information not previously documented, and therefore warrants inclusion as anIB addendumuntil the IB is formally updated.

Revised consent forms (A) are submitted to IRBs, not IBs. Site-specific SAE reports (C) remain at site/sponsor level, not in the IB. Product monograph updates (D) apply to approved products, not investigational ones.

Thus, the correct answer isB (SUSAR report).