CCRP Exam Dumps - Certified Clinical Research Professional (CCRP)

For non–sponsor investigators, responsibilities are limited tosite-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 tosponsors:

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).

Monitors verify compliance with protocol, sponsor SOPs, GCP, and regulations.

ICH E6(R2) 5.18.4:Outlines monitor responsibilities, including verifying informed consent, protocol compliance, investigational product accountability, and adherence to sponsor SOPs.

Monitors must also be familiar with subject-facing documents (A) and storage requirements for investigational product (B).

However,IRB/IEC requirements for reporting to regulatory authoritiesare outside a monitor’s scope. That responsibility lies with investigators and IRBs under21 CFR 56.108(b).

Thus, the correct answer isD.

This question tests drug accountability and dosing calculation, which is central to ICH E6(R2) 4.6 (Investigational product management). Subjects must receive the correct supply and any discrepancy must be reconciled.

The prescribed regimen is 2 mg twice daily = 4 mg per day. With 1 mg tablets, this equals 4 tablets daily. Over 10 days, the subject should consume 40 tablets (4 × 10 = 40). Since 45 tablets were dispensed, the subject should have 5 tablets remaining after 10 days.

Accurate accountability ensures trial integrity and subject safety. Investigators are responsible for maintaining investigational product (IP) records, including dispensing, usage, and returns. According to ICH:

4.6.3: “The investigator/institution should maintain records of the product’s delivery to the trial site, the inventory, the use by each subject, and the return to the sponsor or alternative disposition.”

4.6.5: “The investigator should ensure that investigational products are used only in accordance with the approved protocol.”

Thus, the correct answer is C (5 tablets remain). This reflects proper dosing compliance and highlights the importance of meticulous IP tracking in clinical trials.

ICH E6(R2) 4.5.1:Investigators must follow the protocol approved by the IRB/IEC.

Any modification that is not pre-specified must be approved by sponsor and IRB before continuing.

Only deviations eliminating immediate hazard can be done without prior approval; in this case, continuation requires sponsor + IRB agreement.

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.

21 CFR 11.100(a):Requires that electronic signatures be “unique to one individual and shall not be reused or reassigned to anyone else.”

This ensures accountability and audit trail integrity.

AnInvestigational Device Exemption (IDE)allows an unapproved medical device to be used in aclinical 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 isA (Shipped lawfully for clinical study).

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).