SOCRA Investigational Product Management 3 — Questions and Answers
Question 1: During a monitoring visit, the CRA finds that the drug accountability log shows 5 units dispensed but only 3 subject records document dispensing. What is this discrepancy called?
- A protocol deviation
- A drug accountability discrepancy requiring investigation (Correct answer)
- An acceptable rounding error
- A SUSAR
Correct answer: A drug accountability discrepancy requiring investigation
Any mismatch between IP dispensed per accountability records and subject-level documentation must be investigated and reconciled as a drug accountability discrepancy.
Question 2: Which of the following is the correct procedure when a blinded study requires IP dispensing?
- The PI reviews unblinded kits and selects the appropriate one
- The pharmacist or designee dispenses IP using the randomization code without unblinding the subject or investigator (Correct answer)
- The subject selects their own kit to maintain allocation concealment
- The sponsor ships pre-labeled kits with subject names visible
Correct answer: The pharmacist or designee dispenses IP using the randomization code without unblinding the subject or investigator
In a blinded study, the pharmacist or designated unblinded individual dispenses IP per the randomization system while maintaining the blind for the investigator and subject.
Question 3: A subject returns partially used IP at a follow-up visit. What should the site do with the returned product?
- Dispose of it in the regular trash
- Redistribute it to another eligible subject
- Document the return in the accountability log, assess compliance, and store separately per protocol instructions (Correct answer)
- Return it to the pharmacy shelf for future use
Correct answer: Document the return in the accountability log, assess compliance, and store separately per protocol instructions
Returned IP must be logged, compliance assessed from the amount returned, and stored in a designated area per sponsor instructions until destruction or return to sponsor.
Question 4: What does 'IP reconciliation' refer to in the context of clinical trials?
- Matching subject demographics to IP batch numbers
- Verifying that the total of IP received equals the sum of IP dispensed, returned, and destroyed (Correct answer)
- Reviewing IP labeling against the protocol
- Confirming IRB approval of the IP formulation
Correct answer: Verifying that the total of IP received equals the sum of IP dispensed, returned, and destroyed
IP reconciliation confirms that received quantity = dispensed + returned + destroyed, ensuring full accounting of all investigational product at closeout.
Question 5: A sponsor requires that leftover IP be destroyed on-site. Which document must be completed to support this?
- Adverse Event Report
- IP Destruction Record / Certificate of Destruction (Correct answer)
- Investigator Agreement
- Source document amendment
Correct answer: IP Destruction Record / Certificate of Destruction
A destruction record or certificate of destruction, signed by authorized site personnel, is required to document method, date, and quantity of IP destroyed on-site.
Question 6: Which scenario would require an emergency unblinding of a subject's treatment assignment?
- The subject misses two consecutive study visits
- The subject experiences a serious adverse event where knowledge of treatment is essential for clinical management (Correct answer)
- The sponsor requests it for interim analysis
- A monitoring visit is scheduled the following day
Correct answer: The subject experiences a serious adverse event where knowledge of treatment is essential for clinical management
Emergency unblinding is justified only when knowledge of the treatment assignment is essential to the subject's medical management, per protocol emergency unblinding procedures.
Question 7: According to GCP, how long must drug accountability records be retained after trial completion?
- 1 year
- 2 years after marketing approval or end of IND, whichever is later (Correct answer)
- 6 months
- Indefinitely without any minimum requirement
Correct answer: 2 years after marketing approval or end of IND, whichever is later
Under 21 CFR 312.62, drug accountability records must be retained for 2 years after marketing approval or after IND discontinuation, whichever is later.
SOCRA Investigational Product Management 3
During a monitoring visit, the CRA finds that the drug accountability log shows 5 units dispensed but only 3 subject records document dispensing.
What is this discrepancy called?