Free SOCRA CCRP Exam Dumps June 2026

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).