SOCRA CCRP - Certified Clinical Research Professional (CCRP)

Handling of investigational product (IP), including returns, is governed bysponsor’s written procedures.

ICH E6(R2) 4.6.3:“The investigator/institution should maintain records of the product’s delivery, the inventory, the use by each subject, and the return to the sponsor or alternative disposition.”

ICH E6(R2) 5.13.3:“The sponsor should ensure that written procedures include instructions for… the return or alternative disposition of unused product(s).”

The IB (A) describes pharmacology and safety, not IP logistics. CRO agreements (C) cover contractual duties, not product return processes. Local pharmacy policies (D) may apply operationally but do not override sponsor-required procedures.

Thus, the correct answer isB (The sponsor’s written procedures).

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 areinformed consent forms(to confirm subject protection) andinvestigational product documentation(to confirm reconciliation and disposition).

Correct answer:D.

Outsourcing does not shift ultimate responsibility away from the sponsor. Exact extract:

ICH E6(R2) 5.2.1: “A sponsor may transfer any or all of the sponsor’s trial-related duties… to a CRO,but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor.”Hence, D is correct.

IRBs must review protocols at least annually to ensure ongoing subject protection.

21 CFR 56.109(f):“An IRB shall conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year.”

ICH E6(R2) 3.1.4:“The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk, but at least once per year.”

This establishes12 monthsas the minimum required interval. More frequent reviews (e.g., 6 months) may occur for higher-risk studies, but longer intervals (24–36 months) are not permitted.

Correct answer:B (12 months).

TheInvestigator’s Brochure (IB)compilesclinical and nonclinical dataon an investigational product relevant to human study.

ICH E6(R2) 7.2.3:The IB should summarizenonclinical pharmacology, toxicology, pharmacokinetics, and efficacy data, including results of animal studies.

ICH E6(R2) 7.2.4:It should also includeavailable clinical trial dataand safety experience.

The “results of recent nude mouse study” (B) are nonclinical data, which appropriately belong in the IB. Lab draw requirements (A), dispensing instructions (C), and schedules of events (D) are operational/procedural and are found in theprotocol, not the IB.

Thus, the correct answer isB (Results of recent nude mouse study).

Source data areoriginal 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, theEDC record itself is the original source document. EMRs (B, C) and printouts (D) are secondary records.

Correct answer:A (The EDC record).

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.

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

45 CFR 46.113:“An IRB shall notify theinstitutional 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 isB (Appropriate institutional officials).

Children who are wards of the state receiveadditional protectionsin clinical research.

45 CFR 46.409(b):For research involving wards, “the IRB shall require appointment of an advocate for each child, in addition to any guardian or other advocate who would ordinarily be provided.”

The advocate must have background and experience to act in the child’s best interest and cannot be associated with the research.

Thus, anIRB-appointed advocateis mandatory to ensure independent representation of the ward’s rights.

ICH E6(R2) 4.11.1:Investigators must “immediately report all serious adverse events to the sponsor except for those the protocol identifies as not requiring immediate reporting.”

IRB must also be informed promptly per21 CFR 312.64(b).

Follow-up information is submitted later as available.