SOCRA Updated CCRP Exam Questions and Answers by sayed

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 destructionare 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 isD (Certificate of destruction).

21 CFR 812.150(a)(4):Any deviation from investigational plan made to protect the life or physical well-being of a subject in an emergency must be reported to the sponsor and IRBwithin 5 working days.

Unanticipated adverse device effects have a 10-day reporting window.

21 CFR 312.57(c):“Sponsors shall retain records for2 years after a marketing application is approvedor if not approved, 2 years after shipment and delivery of investigational drug for investigation.”

Children are avulnerable populationrequiring additional protections.

45 CFR 46.408(a):Requires “adequate provisions for soliciting the assent of the children, when in the judgment of the IRB, the children are capable of providing assent.”

45 CFR 46.402:Defines “assent” as a child’s affirmative agreement to participate.

IRBs must consider theage, maturity, and psychological stateof the children when determining assent capability.

Economic status (B) is irrelevant to assent. Physiological status (C) pertains to eligibility, not assent. Provider notification (D) may be local practice but not required by regulation.

Correct answer:A (Psychological status).