Investigational product procurement, storage and accountability MCQs With Answer

Introduction: This quiz collection on investigational product (IP) procurement, storage, and accountability is designed specifically for M.Pharm students preparing for Clinical Research (MPP 104T). It covers regulatory expectations, practical site procedures, and essential documentation practices encountered in real-world clinical trials. Questions focus on sponsor and site responsibilities during procurement, labeling, quarantine, temperature control, monitoring and calibration of storage systems, chain of custody, dispensing, reconciliation, returns and destruction, emergency unblinding, and compliance with ICH-GCP and local regulations. Use these MCQs to test and deepen your understanding of IMP management, identify knowledge gaps, and prepare for both examinations and clinical practice.

Q1. Who holds ultimate responsibility for procuring and supplying the investigational product (IMP) for a clinical trial?

• Investigator at the trial site
• Sponsor
• Institutional Review Board (IRB)/Ethics Committee
• Clinical laboratory

Correct Answer: Sponsor

Q2. Which principle of Good Distribution Practice (GDP) is most critical for investigational product handling?

• Ensuring sterility of all IMP vials
• Maintaining full traceability and chain of custody
• Labeling IMP with patient names
• Using only refrigerated transport

Correct Answer: Maintaining full traceability and chain of custody

Q3. What is the standard recommended storage temperature range for refrigerated investigational products unless otherwise specified?

• -20°C to -10°C
• 2°C to 8°C
• 15°C to 25°C
• Room temperature above 30°C

Correct Answer: 2°C to 8°C

Q4. Which document is primarily used at the investigator site to record receipt, dispensing, return, and destruction of IMP?

• Source documents
• Case report form (CRF)
• IMP accountability log
• Informed consent form

Correct Answer: IMP accountability log

Q5. Upon arrival at a site, when should an investigational product be placed in quarantine?

• Only after it is dispensed to the first subject
• Immediately, pending verification and QA release
• When the study is complete
• Quarantine is not required for IMP

Correct Answer: Immediately, pending verification and QA release

Q6. Which of the following best describes acceptable procedure for destruction of expired or damaged IMP at a clinical site?

• Destroy in regular trash without documentation
• Return to sponsor only; site may never destroy
• Destroyed by authorized personnel according to sponsor/CRO SOP and witnessed, with documentation
• Administer to any staff member to avoid waste

Correct Answer: Destroyed by authorized personnel according to sponsor/CRO SOP and witnessed, with documentation

Q7. When a temperature excursion is detected in an IMP storage unit, the immediate and required actions include:

• Ignore if the IMP appears intact
• Document the excursion, quarantine affected stock, notify sponsor/QA, and assess impact
• Dispense IMP quickly before it degrades
• Dispose of all IMP without documentation

Correct Answer: Document the excursion, quarantine affected stock, notify sponsor/QA, and assess impact

Q8. How often should IMP accountability reconciliation be performed at a trial site?

• Only at study initiation
• At each dispensing event and at study close-out
• Once every five years
• Only when the sponsor requests it

Correct Answer: At each dispensing event and at study close-out

Q9. What is the purpose of an emergency unblinding code list in blinded studies?

• To allow routine access to treatment assignments by all staff
• To permit emergency unblinding for individual subjects while preserving overall trial blinding
• To randomize subjects at the site level
• To document IMP temperature excursions

Correct Answer: To permit emergency unblinding for individual subjects while preserving overall trial blinding

Q10. Which best defines “chain of custody” for investigational products?

• The schedule for subject visits and dosing
• Continuous documentation of IMP possession, transfer, and storage with accountable signatures
• The study randomization schedule
• A record of adverse events related to IMP

Correct Answer: Continuous documentation of IMP possession, transfer, and storage with accountable signatures

Q11. Which labeling element is mandatory for investigational products in most regulatory jurisdictions?

• Patient name and diagnosis
• “For Clinical Trial Use” or equivalent statement, unique code, sponsor contact and storage conditions
• Manufacturer retail price
• Printable barcode only

Correct Answer: “For Clinical Trial Use” or equivalent statement, unique code, sponsor contact and storage conditions

Q12. What is the appropriate initial action when unused IMP is returned by a subject to the site?

• Immediately re-dispense to another subject
• Quarantine and document return, then follow sponsor instructions for return or destruction
• Discard in clinical waste without record
• Store in the refrigerator indefinitely

Correct Answer: Quarantine and document return, then follow sponsor instructions for return or destruction

Q13. In a double-blind study, the site accountability records should maintain which of the following?

• Direct record of treatment allocation for every subject in a public file
• Dispensing records that document kit identifiers without revealing treatment allocation
• Only the amount dispensed, without kit identifiers
• No records at all to preserve blinding

Correct Answer: Dispensing records that document kit identifiers without revealing treatment allocation

Q14. Best practice for frequency of calibration and validation of temperature monitoring devices used for IMP storage is:

• Never calibrate; use manufacturer settings
• At least annually (every 12 months) or per sponsor/site SOP and local regulations
• Only when a temperature excursion occurs
• Calibrate once at installation and never again

Correct Answer: At least annually (every 12 months) or per sponsor/site SOP and local regulations

Q15. In the European Union, what is a primary responsibility of the Qualified Person (QP) regarding IMP?

• Collecting informed consent from subjects
• Certifying batch release of IMP for clinical use in the EU
• Designing the study protocol
• Conducting randomization at site level

Correct Answer: Certifying batch release of IMP for clinical use in the EU

Q16. During an emergency where a subject’s health requires knowledge of treatment assignment, who is responsible for unblinding and what follow-up is required?

• The investigator may unblind per emergency procedure and must notify sponsor and document the reason and time
• The subject decides and no documentation is needed
• The IMP manufacturer unblinds without informing the site
• No one may unblind under any circumstance

Correct Answer: The investigator may unblind per emergency procedure and must notify sponsor and document the reason and time

Q17. Which security measures are expected for IMP storage at a clinical site?

• Open shelving accessible to all hospital staff
• Secure, restricted-access storage with locked cabinets and limited authorized personnel
• Storage in public clinic reception area
• Storage in subject’s homes between visits

Correct Answer: Secure, restricted-access storage with locked cabinets and limited authorized personnel

Q18. What does accountability reconciliation at study close-out typically involve?

• Comparing expected IMP inventory from records to actual stock, documenting discrepancies, and arranging return/destruction
• Deleting IMP records to save space
• Transferring all IMP to the pharmacy without documentation
• Simply certifying the study as complete without physical count

Correct Answer: Comparing expected IMP inventory from records to actual stock, documenting discrepancies, and arranging return/destruction

Q19. When IMP is found to be expired during routine inventory, the correct immediate action is:

• Continue using until sponsor notices
• Quarantine the expired stock, document findings, notify sponsor/QA for disposition instructions
• Label it as placebo and use it
• Discard it in standard medical waste without notification

Correct Answer: Quarantine the expired stock, document findings, notify sponsor/QA for disposition instructions

Q20. Which international guidance explicitly outlines responsibilities and expectations for handling investigational products in clinical trials?

• ICH E6 Good Clinical Practice
• ISO 9001 only
• ICH Q7 for active pharmaceutical ingredients only
• Any local newspaper guideline

Correct Answer: ICH E6 Good Clinical Practice

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