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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).

21 CFR 56.115(a)(5):IRBs must retain records of IRB membership (names, qualifications, affiliations, occupations).

Other documents (contracts, enrollment logs, product labels) are site or sponsor responsibilities, not IRB’s.

Upon study closure, investigators must maintain documentation that allows subject data to be linked back if necessary. TheSubject Identification Code Listis a key essential document for ensuring traceability while maintaining confidentiality.

ICH E6(R2) 8.3.21:“Subject Identification Code List — A list of all subjects randomized to trial numbers, allowing investigator to identify each subject in case follow-up is required. This list should be kept in a confidential manner and retained for the maximum retention period.”

ICH E6(R2) 8.4:Essential documents for investigators include items needed for subject identification, protocol compliance, and trial closure.

Other listed documents (randomization list, monitoring report, audit certificate) are maintained by the sponsor, not the investigator. Thesubject code listensures that in the event of a safety issue, regulatory authority queries, or subject withdrawal, the investigator can trace back records.

Thus, the correct answer isB (Completed Subject Identification Code List).

When a trial ends at a site, the investigator has an obligation to submit a final report to the IRB/IEC. This is outlined in both ICH and CFR:

ICH E6(R2) 4.13: “Upon completion of the trial, the investigator should provide the IRB/IEC with a summary of the trial’s outcome.”

21 CFR 312.66: Requires investigators to “report to the IRB all changes in the research activity and all unanticipated problems involving risk, and to provide reports at the end of the study.”

The final report provides closure and documentation that the study was conducted ethically and in compliance with regulatory standards. Other documents listed in the options (monitoring reports, DSMB summaries, subject logs) may be retained by the sponsor or site, but they are not mandated for IRB submission.

Thus, the correct answer is A (Final Report). This ensures the IRB/IEC has an accurate record of study completion, outcome, and compliance with ethical oversight.

Sponsors are responsible for distributing safety updates across all investigators and the FDA.

21 CFR 312.55(b):“The sponsor shall promptly notify all participating investigators, and the FDA, of new significant adverse effects or risks with respect to the drug.”

Other responsibilities fall elsewhere:

Case histories (C) are maintained by investigators (21 CFR 312.62(b)).

Progress reports to IRBs (D) are the investigator’s duty (21 CFR 312.66).

Administration of investigational drug (A) is managed by the investigator at site level.

Thus, the correct answer isB (Ensuring FDA and investigators are promptly informed).

The IRB/IEC is empowered to protect subjects and ensure informed consent remains accurate, complete, and understandable.

ICH E6(R2) 3.1.2:“The IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid… when considering the adequacy and completeness of the written information to be provided to the subjects.”

21 CFR 56.109(b):“The IRB shall require that information given to subjects as part of informed consent is in accordance with §50.25.The IRB may require that information, in addition to that specifically mentioned in §50.25, be given to the subjects when in its judgment the information would meaningfully add to the protection of the rights and welfare of subjects.”

This confirms that the IRB/IEC has unilateral authority to request additional information at any time, regardless of sponsor or investigator agreement.

Thus, the correct answer isA (At any time, at the discretion of the IRB/IEC).

Outsourcing does not shift ultimate responsibility away from the sponsor. Exact extract:

ICH E6(R2) 5.2.1: “A sponsor may transfer any or all of the sponsor’s trial-related duties… to a CRO,but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor.”Hence, D is correct.

420 subjects ÷ 42 months (3.5 years) =10 subjects/month.

However, “expected average” often rounds up to next whole number, ensuring enrollment goals are met. Thus,11/monthis correct.

This calculation is important for feasibility assessments and protocol planning.

21 CFR 54.2(f) & 54.4(a):Requires disclosure of “significant payments of other sorts” (SPOOS) that exceed$25,000or equity interests exceeding$50,000.

However,honoraria or consulting exceeding $10,000 annuallyalso trigger disclosure.

Thus, the reporting threshold is$10,000.

Phase IV studies (post-marketing) examine real-world safety and effectiveness.

ICH E8(R1):Describes Phase IV as “studies performed after drug approval to delineate additional information including the drug’s risks, benefits, and optimal use.”

They often test drugs innew or broader populationsbeyond original approval.

While dosing and schedules are Phase I–III, Phase IV focuses onnew patient populationsor long-term outcomes.