Free SOCRA Certified Clinical Research Professional CCRP Exam Questions

The FDA has full regulatory authority to inspect IRB/IEC records.

21 CFR 56.115(b): ''The IRB shall permit representatives of the Food and Drug Administration to inspect and copy all records maintained... at reasonable times and in a reasonable manner.''

Thus, FDA may inspect and copy IRB/IEC records without requiring an affidavit or invitation. This ensures regulatory oversight and human subject protection.

Incorrect options:

(A) limits authority incorrectly.

(C) is false --- FDA explicitly regulates IRBs.

(D) is false --- FDA does not need IRB invitation.

Correct answer: B.

21 CFR 56.115(b).

Endpoint data collection is based on protocol design and subject compliance, not CRF formatting.

ICH E6(R2) 4.9.0: Investigator responsible for data accuracy regardless of CRF complexity.

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.

21 CFR 812.150(a)(1): Investigators must report unanticipated adverse device effects to the sponsor within 10 working days.

Sponsor is then responsible for notifying FDA and all investigators.

Informed consent is a fundamental ethical requirement. If it is violated in a device trial, the FDA requires rapid reporting.

21 CFR 812.150(b)(5): States that a sponsor shall submit to FDA ''any report of use of a device without obtaining informed consent, within 5 working days after the sponsor first receives notice of such use.''

This expedited reporting ensures FDA oversight of serious violations and protection of human subjects.

Incorrect options:

A (1 day) is overly strict and not codified.

C (10 days) and D (30 days) are too delayed to meet regulatory intent of immediate oversight.

Thus, the correct timeline is within 5 working days.

21 CFR 812.150(b)(5).

In device trials, unanticipated adverse device effects (UADEs) must be promptly reported.

21 CFR 812.150(a)(1): ''An investigator shall submit to the sponsor and the reviewing IRB a report of any unanticipated adverse device effect as soon as possible, but in no event later than 10 working days after the investigator first learns of the effect.''

In this case, severe burns with blistering go beyond the anticipated effect of mild burns listed in the investigational plan. Therefore, it qualifies as a UADE and triggers expedited reporting. Options A, B, and C are too short; the regulation specifically mandates a 10 working day maximum timeframe.

Thus, the correct answer is D (10 working days).

21 CFR 812.150(a)(1) (Reporting requirements for investigators).

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), 5.18.3.

IRBs must be diverse and independent to protect human subjects.

21 CFR 56.107(d): ''Each IRB shall include at least one member whose primary concerns are in nonscientific areas... and at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person affiliated with the institution.''

There is no minimum requirement of seven members (A). Nonscientists must be represented but not a majority (B). Clergy are not mandated (C). The critical safeguard is inclusion of at least one unaffiliated member (D) to ensure independence.

Thus, the correct answer is D (At least one unaffiliated individual).

21 CFR 56.107(d) (IRB membership requirements).

Investigators must formally close out a trial with the IRB/IEC.

ICH E6(R2) 4.13.2: ''Upon completion of the trial, the investigator/institution should provide the IRB/IEC with a summary of the trial's outcome.''

21 CFR 312.66: Reinforces investigator's duty to keep IRB informed throughout study lifecycle.

This applies regardless of whether outcomes were positive, negative, or inconclusive. IRBs are not concerned with sponsor payments (B) or publications (D).

Thus, the correct answer is A (Provide final report to IRB/IEC).

ICH E6(R2), 4.13.2 (Final reporting requirement).

ICH E6(R2) 5.6.1: ''The sponsor should ensure agreement from the investigator/institution on the financial aspects of the trial.''

This ensures transparency in compensation, reimbursement, and budget.