During the closeout visit, a monitor is completing the documentation of reconciliation of investigational product. All packaging, as well as the used and unused investigational product, are being returned to the sponsor for disposition. Which of the following documents would NOT be required to be filed at the research site?
Answer(s): D
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) 8.2.148.2.16: 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), §8.2.148.2.16 (Essential documents).
In accordance with 21 CFR Part 11, in order for an electronic record to be equivalent to a paper record the electronic record must be:
Answer(s): B
21 CFR Part 11 governs the use of electronic records and electronic signatures in FDA-regulated research.21 CFR 11.10(a): Requires "validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records."Validated systems ensure equivalency between electronic and paper records.While access controls (D) are also mandated, they are part of system validation, not the defining requirement. Printing/signing paper copies (A) is unnecessary under Part 11. Entry into an eCRF (C) is just one function, not sufficient for compliance.Thus, the correct answer is B (Managed within a validated computer system).
21 CFR 11.10(a) (System validation requirement).
The reviewing IRB/IEC determined that a minimal risk sponsor-investigator study is exempt from IRB/IEC review. How often, if ever, is the sponsor-investigator required to submit a continuing review to the IRB/IEC?
Minimal risk studies may qualify for exemption or expedited review under 45 CFR 46.101(b).45 CFR 46.109(f): "Unless an IRB determines otherwise, continuing review of research is not required for research eligible for expedited review and determined to involve no more than minimal risk."ICH E6(R2) 3.1.4: Requires IRB review for clinical trials, but exemptions exist for minimal risk studies.Therefore, once exempted, there is no requirement for continuing review, unless specifically required by the IRB. Submission at closure is optional depending on institutional policy but not a federal requirement.Thus, the correct answer is D (No such requirement).
45 CFR 46.109(f) (Exempt and expedited reviews).
Upon completion of a study, the investigator should do which of the following?
Answer(s): A
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).
After the completion of a Phase II IND study closeout monitoring visit, which of the following parties is responsible for maintaining the closeout monitoring report?
Monitoring reports are sponsor-controlled documents.ICH E6(R2) 5.18.6: "The monitor should submit a written report to the sponsor after each trial-site visit... The sponsor should review and follow up on the monitoring report."ICH E6(R2) 8.1 & 8.2.22: Monitoring visit reports are essential documents maintained by the sponsor.Investigators are not required to retain monitoring reports; they maintain site regulatory binders and subject records. The study coordinator assists investigators, but does not hold sponsor-owned reports. IRBs also do not receive sponsor monitoring reports.Thus, the correct answer is B (The sponsor).
ICH E6(R2), §5.18.6 (Monitoring reports).ICH E6(R2), §8.2.22 (Essential documents: monitoring visit reports).
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