CPI Investigational Product Management & Drug Accountability 1 — Questions and Answers
Question 1: What is the primary purpose of maintaining drug accountability records in a clinical trial?
- To track the cost of investigational products for billing purposes
- To ensure investigational product is used only as specified in the protocol and accounted for throughout the trial (Correct answer)
- To satisfy marketing requirements set by the pharmaceutical sponsor
- To document adverse events related to investigational product use
Correct answer: To ensure investigational product is used only as specified in the protocol and accounted for throughout the trial
Drug accountability records ensure that investigational products are dispensed, used, and returned or destroyed as specified by the protocol, maintaining trial integrity and regulatory compliance.
Question 2: According to FDA regulations, who at the investigational site bears primary responsibility for investigational product accountability?
- The study coordinator
- The sponsor's clinical research associate
- The principal investigator (Correct answer)
- The IRB pharmacist representative
Correct answer: The principal investigator
Under 21 CFR Part 312, the principal investigator is ultimately responsible for ensuring investigational product is used only for subjects under their supervision and that accountability records are maintained.
Question 3: Which of the following must be documented each time an investigational product is dispensed to a study subject?
- Subject's insurance information and copay amount
- Date, quantity dispensed, lot number, expiration date, and subject identifier (Correct answer)
- Subject's social security number and emergency contact
- Sponsor's manufacturing facility address and batch certificate
Correct answer: Date, quantity dispensed, lot number, expiration date, and subject identifier
Dispensing records must capture date, quantity, lot number, expiration date, and subject identifier to create a complete chain of custody and enable reconciliation.
Question 4: What action is required when a shipment of investigational product arrives at the clinical site?
- Immediately distribute to subjects to avoid storage fees
- Return unopened to sponsor until IRB approval is confirmed
- Inspect shipment, verify contents against shipping manifest, and document receipt in accountability log (Correct answer)
- Repackage in study-blind containers before logging receipt
Correct answer: Inspect shipment, verify contents against shipping manifest, and document receipt in accountability log
Upon receipt, site staff must inspect the shipment for damage, verify contents against the shipping manifest, check storage conditions during transit, and document the receipt in the drug accountability log.
Question 5: A refrigerated investigational product requires storage at 2°C–8°C. The site refrigerator log shows a temperature excursion to 12°C for 4 hours. What is the most appropriate immediate action?
- Discard the product immediately without notification
- Continue dispensing since the excursion was brief
- Quarantine the affected product and notify the sponsor for disposition guidance (Correct answer)
- Re-cool the product and document the event in the next monitoring visit
Correct answer: Quarantine the affected product and notify the sponsor for disposition guidance
Temperature excursions require immediate quarantine of affected product and sponsor notification so the sponsor's quality team can evaluate stability data and provide disposition instructions.
Question 6: At study completion or early termination, what must happen to unused investigational product?
- The investigator may keep it for compassionate use in non-study patients
- It must be returned to the sponsor or destroyed per sponsor instructions, with documentation (Correct answer)
- It should be donated to a local pharmacy to reduce waste
- It is automatically absorbed into the site's general drug inventory
Correct answer: It must be returned to the sponsor or destroyed per sponsor instructions, with documentation
All unused investigational product must be either returned to the sponsor or destroyed under sponsor-approved procedures, and both actions must be fully documented to close out drug accountability.
Question 7: Which document provides the site with specific instructions for receiving, storing, dispensing, and returning investigational product?
- The IRB approval letter
- The informed consent form
- The Investigator's Brochure (IB)
- The Pharmacy Manual or Investigational Product Management Plan (Correct answer)
Correct answer: The Pharmacy Manual or Investigational Product Management Plan
The Pharmacy Manual (or Investigational Product Management Plan) issued by the sponsor contains site-specific instructions for all IP handling procedures, including storage conditions, dispensing rules, and return/destruction requirements.
CPI Investigational Product Management & Drug Accountability 1
What is the primary purpose of maintaining drug accountability records in a clinical trial?