The Certified Clinical Research Professional (CCRP) (CCRP)

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.

An Investigational Device Exemption (IDE) allows an unapproved medical device to be used in a clinical investigation .

21 CFR 812.1(a): “An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act that would otherwise apply.”

It does not allow commercial sale (B), non-study clinical use (C), or marketing as a humanitarian device (D).

Thus, the correct answer is A (Shipped lawfully for clinical study).

Retention of essential documents ensures accountability and inspection readiness.

ICH E6(R2) 5.5.12 & 8.1: Sponsors should retain essential documents “until at least 2 years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications or at least 2 years after formal discontinuation of clinical development of the investigational product.”

This standard balances subject protection with practical recordkeeping. Longer durations (B–D) may apply under institutional or national rules, but ICH establishes 2 years minimum .

Correct answer: A (2 years).

If IRB/IEC approval is suspended or terminated, reporting is required to protect oversight and accountability.

45 CFR 46.113: “An IRB shall notify the institutional officials, the department or agency head, and OHRP (when applicable) of any suspension or termination of IRB approval.”

This ensures transparency and institutional responsibility for compliance. Internal hospital committees or directors (A, C, D) are not mandated reporting entities.

Thus, the correct answer is B (Appropriate institutional officials).

Drug storage conditions are essential to maintaining investigational product (IP) integrity. According to ICH:

ICH E6(R2) 5.13.3: “The sponsor should ensure that investigational products are stored… under appropriate conditions as specified by the sponsor and in accordance with applicable regulatory requirement(s).”

ICH E6(R2) 4.6.4: “The investigator/institution should store the investigational product(s) as specified by the sponsor (and in accordance with applicable regulatory requirement(s)), and ensure that product(s) are used only in accordance with the approved protocol.”

During site qualification/selection, the monitor evaluates storage conditions — particularly temperature ranges — to ensure the site can meet the stability requirements for the IP. Factors like staff numbers, space, and cost are operational considerations but not regulatory determinants of site qualification.

Thus, the correct answer is C (Storage facility temperature range) . This ensures compliance with sponsor specifications, product stability, and ultimately subject safety.

For non–sponsor investigators, responsibilities are limited to site-level conduct and product accountability .

ICH E6(R2) 4.6.1: “Responsibility for investigational product(s) accountability at the trial site rests with the investigator/institution.”

21 CFR 312.61: Requires the investigator to administer investigational drugs only to subjects under their supervision and maintain control.

Other responsibilities listed belong to sponsors :

A: Reporting SAEs to FDA is a sponsor duty (investigators report to sponsor, not directly to FDA).

B: Monitoring at all sites is a sponsor responsibility.

C: Disseminating safety updates is a sponsor’s role.

Correct answer: D (Maintaining control of IP).

Monitoring ensures trial integrity and subject safety.

ICH E6(R2) 5.18.3: “The sponsor should ensure that the trials are adequately monitored. The determination of the extent and nature of monitoring should be based on considerations such as the objective, purpose, design, complexity, blinding, size, and endpoints of the trial.”

Monitoring must occur before (initiation visit), during (periodic), and after (closeout).

It is not limited to fixed weekly or monthly intervals (A, B) and not as infrequent as yearly (D). Instead, it is risk-adapted and flexible , but must cover all phases of the study.

Correct answer: C (Timely manner before, during, and after).

ICH E6(R2) 5.13.3: The sponsor is responsible for the supply, storage, and final disposition of investigational product.

21 CFR 312.59: Sponsors must assure return or proper disposition of unused supplies.

Sites must follow sponsor’s written procedures for reconciliation, return, or destruction, not IRB or pharmacy processes.

Sponsor audits ensure systems comply with GCP.

ICH E6(R2) 5.19.3: “The sponsor’s auditing procedures should include a review of quality assurance audits and audit reports .”

Audit reports document findings from independent evaluations and are essential for ensuring compliance.

SOPs (A) are reviewed during audits but are not mandated as standalone “audit review documents.” Personnel files (B) and financial reports (C) are not required under GCP auditing provisions.

Correct answer: D (Audit reports).