Free SOCRA CCRP Exam Dumps October 2026

When reviewing protocols, IRBs/IECs are primarily responsible for safeguarding human subjects by evaluating risks, benefits, and fairness in subject selection.

21 CFR 56.111(a)(3): ''In making its determination the IRB shall determine that... selection of subjects is equitable.''

45 CFR 46.111(a)(3): Repeats this requirement, emphasizing fairness across gender, race, age, and socioeconomic status.

Other options:

Patient population availability (A) is a feasibility issue, addressed by investigators and sponsors, not IRBs.

Education of the study team (C) is confirmed by the sponsor and investigator, not IRB.

Funding sources (D) may raise conflict of interest concerns, but they are not IRB approval criteria per federal regulations.

Thus, IRBs focus on justice and fairness in subject selection as part of the Belmont Report principles.

21 CFR 56.111(a)(3).

Belmont Report (Justice principle).

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.

Investigators must document the receipt, use, return, or alternative disposition of investigational product (IP).

ICH E6(R2) 4.6.3: Requires investigators to maintain records of IP delivery, inventory, use by subjects, and return/disposition.

ICH E6(R2) 8.2.14--8.2.16: Essential documents include shipment records, accountability logs, and inventory records.

However, certificates of destruction are generated and retained by the sponsor (or authorized destruction facility), not required at the site unless the destruction occurred there. In this scenario, all IP was returned to the sponsor, so no destruction certificate would exist at the site.

Thus, the correct answer is D (Certificate of destruction).

ICH E6(R2), 4.6.3 (Investigator product accountability).

ICH E6(R2), 8.2.14--8.2.16 (Essential documents).

During study closeout, the monitor verifies subject protection, protocol compliance, and investigational product accountability.

ICH E6(R2) 8.1 & 8.4: Lists essential documents to be verified at closeout, including signed informed consent forms and investigational product accountability records.

21 CFR Part 11: Ensures electronic records are valid, so printed copies are not always necessary unless required for auditing.

Thus, the critical items for monitor review at closeout are informed consent forms (to confirm subject protection) and investigational product documentation (to confirm reconciliation and disposition).

Correct answer: D.

ICH E6(R2), 8.1, 8.4.

Source data are original records where data are first recorded.

ICH E6(R2) 1.51: Defines source data as ''all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.''

Since subjects directly enter responses into the EDC, the EDC record itself is the original source document. EMRs (B, C) and printouts (D) are secondary records.

Correct answer: A (The EDC record).

ICH E6(R2), 1.51 (Definition of source data).

21 CFR 56.109(a): IRBs must review all changes to informed consent before implementation.

ICH E6(R2) 4.8.2: If new information could affect willingness to continue, consent forms must be revised and approved by the IRB.

Even though screening is closed, the IRB/IEC must review the updated form before any subject re-consenting.

The FDA has authority to impose clinical holds and terminations on IND studies when subject safety is at risk.

21 CFR 312.44(b)(1): ''The FDA may propose to terminate an IND if it finds that human subjects would be exposed to an unreasonable and significant risk of illness or injury.''

21 CFR 312.42(e): ''If an IND is placed on clinical hold and the deficiencies have not been adequately addressed within 30 days, FDA may terminate the IND.''

Annual reports (A) are required but noncompliance usually results in clinical hold, not immediate termination. IRB approval delays (B) do not trigger termination; the site simply cannot begin. Investigators report safety data to sponsors, not directly to FDA (C).

Thus, the correct answer is D (The FDA issued a clinical hold, and 30 days have elapsed).

21 CFR 312.44(b)(1) (Termination of an IND).

21 CFR 312.42(e) (Clinical hold procedures).