Close-out activities, archival and investigational product destruction MCQs With Answer

Introduction:
This quiz collection focuses on close-out activities, archival requirements, and investigational product (IP) destruction — core components of clinical trial completion and compliance for M.Pharm students. Questions cover regulatory expectations (ICH GCP, FDA/EMA references), sponsor and investigator responsibilities, documentation and certificates, chain of custody, temperature-controlled product handling, blinded product issues, and secure archival of essential records. Each MCQ is designed to deepen understanding of practical procedures, SOP alignment, and quality oversight required during trial close-out and final disposition of IP and trial records. Use these items to sharpen decision-making skills relevant to audits, inspections, and responsible clinical trial management.

Q1. What is the primary purpose of the clinical trial close-out visit?

• To confirm investigational product accountability, complete CRFs, resolve outstanding queries and arrange archival
• To recruit additional subjects for an extension study
• To perform baseline assessments for a future trial
• To negotiate pricing of the investigational product with vendors

Correct Answer: To confirm investigational product accountability, complete CRFs, resolve outstanding queries and arrange archival

Q2. Who holds ultimate responsibility for arranging destruction of investigational product at the end of a clinical trial?

• The sponsor or the sponsor’s authorised representative
• The site receptionist
• The local ethics committee without sponsor input
• The study subjects

Correct Answer: The sponsor or the sponsor’s authorised representative

Q3. According to ICH GCP, for how long should essential trial documents be retained after the last marketing application approval in an ICH region?

• At least 2 years after the last approval or after formal discontinuation of clinical development
• At least 5 years irrespective of approvals
• Only until study close-out visit is completed
• Indefinitely without any defined period

Correct Answer: At least 2 years after the last approval or after formal discontinuation of clinical development

Q4. Which document is essential to evidence that investigational product has been destroyed at a site?

• A Certificate of Destruction detailing lot numbers, quantities, date, method and authorized signatures
• A copy of the original trial protocol only
• An informal email from the site coordinator
• A photograph of an empty storage area without signatures

Correct Answer: A Certificate of Destruction detailing lot numbers, quantities, date, method and authorized signatures

Q5. When should investigational product reconciliation be performed to ensure accurate accountability?

• At each study visit and again at the close-out visit
• Only at study initiation
• Only when a subject withdraws from the study
• After regulatory inspection has occurred

Correct Answer: At each study visit and again at the close-out visit

Q6. Which of the following describes acceptable approaches for destruction of investigational product?

• Destruction per a documented SOP (e.g., incineration or chemical neutralization) with witness, documentation and Certificate of Destruction
• Flushing tablets down the sink without documentation
• Discarding product in general waste bins
• Allowing staff to take remaining product home for disposal

Correct Answer: Destruction per a documented SOP (e.g., incineration or chemical neutralization) with witness, documentation and Certificate of Destruction

Q7. Which items must be included in the written record of IP destruction at site?

• Unique identifiers (lot/batch numbers), quantities destroyed, date/time, method, names and signatures of authorizing person and witness
• Only the method of destruction without quantities or signatures
• Only a verbal statement by the investigator
• Patient names of those who received the product

Correct Answer: Unique identifiers (lot/batch numbers), quantities destroyed, date/time, method, names and signatures of authorizing person and witness

Q8. Under what conditions may blinded investigational product be destroyed at a site?

• Only after formal unblinding and sponsor/CRO authorization with documented approval
• Immediately after the last subject visit without authorization
• When the site pharmacist decides it is convenient
• Never — blinded product must remain on site indefinitely

Correct Answer: Only after formal unblinding and sponsor/CRO authorization with documented approval

Q9. Who is responsible for archival of essential clinical trial documents after study completion?

• The sponsor (or a sponsor-designated archival facility) retains overall responsibility for secure long-term storage
• The study subjects
• The courier company used for shipment only
• The trial monitor alone without sponsor oversight

Correct Answer: The sponsor (or a sponsor-designated archival facility) retains overall responsibility for secure long-term storage

Q10. What is required when transferring archived trial records to a new custodian?

• A written agreement documenting transfer, chain-of-custody records and acknowledgement of retention responsibilities
• Only a verbal confirmation over the phone
• No documentation is needed if the new custodian is in the same city
• Destruction of the original records immediately after transfer

Correct Answer: A written agreement documenting transfer, chain-of-custody records and acknowledgement of retention responsibilities

Q11. What is a critical requirement when performing a witnessed destruction to ensure auditability?

• Documentation signed by both an authorised initiator and an independent witness, including date/time and quantities
• Only a photograph of the destruction process
• A note in an informal notebook without signatures
• Deleting the destruction entry from the accountability log after completion

Correct Answer: Documentation signed by both an authorised initiator and an independent witness, including date/time and quantities

Q12. Which of the following best describes good practices for archival of electronic trial records?

• Use of validated systems with secure access controls, audit trails, regular backups and a migration plan to preserve readability over time
• Printing all electronic records and discarding electronic originals immediately
• Storing files on a personal USB drive without encryption
• Relying on a single computer in the site office with no backups

Correct Answer: Use of validated systems with secure access controls, audit trails, regular backups and a migration plan to preserve readability over time

Q13. The decision to return investigational product to the sponsor versus destroying it at site should be based primarily on what?

• The sponsor’s written instructions and applicable regulatory/protocol requirements
• The investigator’s personal preference
• The cheapest available option for the site
• How much storage space is left at the site

Correct Answer: The sponsor’s written instructions and applicable regulatory/protocol requirements

Q14. When should the Institutional Ethics Committee (IEC/IRB) be notified about study termination or completion?

• Promptly after study termination/completion according to IEC timelines (commonly within 30–90 days)
• Only if there was a serious adverse event
• Never — IRBs do not need to be informed about closure
• Five years after study completion

Correct Answer: Promptly after study termination/completion according to IEC timelines (commonly within 30–90 days)

Q15. Which elements should a Certificate of Destruction contain to be regulatorily acceptable?

• Product identification (trade name, batch/lot), quantities, method of destruction, date/time, location, signatories and witness details
• Only the name of the person who witnessed the destruction
• Only the method of destruction without product identifiers
• Only an invoice from the waste disposal company

Correct Answer: Product identification (trade name, batch/lot), quantities, method of destruction, date/time, location, signatories and witness details

Q16. Which documents at the investigator site are considered essential and must be archived after study completion?

• Protocol and amendments, signed informed consents, CRFs, source documents, IP accountability logs, monitoring visit reports and correspondence — essentially all essential documents
• Only the informed consent forms
• Only the last monitoring visit report
• Only emails between sponsor and site staff

Correct Answer: Protocol and amendments, signed informed consents, CRFs, source documents, IP accountability logs, monitoring visit reports and correspondence — essentially all essential documents

Q17. Who ensures that investigational product destruction processes conform to GMP and sponsor quality requirements?

• The sponsor or sponsor-designated QA/designee, in coordination with qualified site personnel
• The study subjects
• The courier who delivered the IP initially
• No one — destruction does not require QA oversight

Correct Answer: The sponsor or sponsor-designated QA/designee, in coordination with qualified site personnel

Q18. If improper or undocumented destruction of investigational product is discovered during an audit, what is the appropriate immediate action?

• Notify the sponsor, document the deviation, preserve any remaining material, and report to the IRB/regulatory authorities if required
• Ignore the finding and proceed with archival
• Destroy all remaining records to hide the problem
• Only inform the site receptionist

Correct Answer: Notify the sponsor, document the deviation, preserve any remaining material, and report to the IRB/regulatory authorities if required

Q19. What documentation is essential for temperature-controlled investigational product at close-out?

• Complete temperature logs, calibration certificates for storage equipment, excursion reports and shipping/handling records
• Only photographs of the refrigerator interior
• Only the shipping invoice without temperature data
• Only the investigator’s verbal confirmation of storage conditions

Correct Answer: Complete temperature logs, calibration certificates for storage equipment, excursion reports and shipping/handling records

Q20. How should randomization codes and blinding information be handled at study close-out?

• Retained securely by the sponsor until database lock and final analysis; site must not destroy or unblind codes without sponsor authorization
• Destroyed by the site immediately after the last subject visit
• Published publicly to allow external verification
• Handed over to the local pharmacy without documentation

Correct Answer: Retained securely by the sponsor until database lock and final analysis; site must not destroy or unblind codes without sponsor authorization

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