CCRP Exam Dumps : Certified Clinical Research Professional (CCRP)

ICH E6(R2) 5.5.12 & 8.1:Essential documents must be retained2 years after the last approval of a marketing application in an ICH region and until no applications are pending, or2 years after discontinuation of development.

This ensures availability for inspection.

The sponsor holds ultimate responsibility for trial oversight and compliance.

ICH E6(R2) 5.20.1:If noncompliance is discovered, the sponsor must “take prompt action to secure compliance” and, if necessary, terminate participation of the investigator/institution.

21 CFR 312.56(b):Sponsors must ensure proper conduct and report investigators who fail to comply to the FDA and IRB.

While investigators commit to protocol adherence, once deviations are identified,the sponsor must actto safeguard subjects and trial validity.

Theinvestigatoris directly responsible for ensuring that the IRB/IEC reviews and approves the research both initially and on a continuing basis. This responsibility is not delegable to the sponsor or study staff.

ICH E6(R2) 4.4.1:“Before initiating a trial, the investigator/institution should have written and dated approval/favorable opinion from the IRB/IEC for the trial protocol, written informed consent form, consent form updates, and any other written information to be provided to subjects.”

21 CFR 312.66:“An investigator shall assure that an IRB that complies with the requirements… will be responsible for the initial and continuing review and approval of the proposed clinical study.”

This means that while the sponsor submits documents to the FDA and oversees general compliance, theinvestigator has the obligation to obtain and maintain IRB approvalat their site. The monitor or study coordinator may assist in documentation, but legal responsibility rests with the investigator.

Thus, the correct answer isC (The investigator).