Pass Using CCRP Exam Dumps

Providing acopy of the signed consent formto subjects is a mandatory requirement.

21 CFR 50.27(a):“A copy shall be given to the person signing the form.”

ICH E6(R2) 4.8.11:Reinforces that “a copy of the signed and dated written informed consent form should be given to the subject.”

Failure to provide this copy constitutes adirect violation of informed consent regulations.

Other issues:

A & C concern proper short form process but do not invalidate informed consent if a copy was provided.

D concerns sponsor template, but the site’s responsibility is ensuring use of IRB-approved version.

Correct answer:B.

TheInvestigator’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 isno requirementto notify IRB/IEC unless subject safety, rights, or risk profile is affected.

Since this update containedno 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 theregulatory binderand implemented at the site.

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

ICH E6(R2) 5.5.3:Sponsors are responsible for validating computerized systems used in trials.Investigators ensure proper data entry, but system compliance lies with sponsor.

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.