ACRP ACRP Investigational Product Management 2 — Questions and Answers
Question 1: What is an IP dispensing error and how should it be handled in a clinical trial?
- A scheduled dose change; document in protocol
- An incorrect dose or product given; report and document immediately per protocol (Correct answer)
- A delayed shipment; notify the sponsor quarterly
- A misplaced log entry; correct with white-out
Correct answer: An incorrect dose or product given; report and document immediately per protocol
Dispensing errors must be immediately documented and reported to the sponsor and possibly the IRB, as they may constitute protocol deviations.
Question 2: What information is typically required on an investigational product label per FDA regulations?
- Participant's insurance information
- Protocol number, IND number, caution statement, storage conditions, and sponsor contact (Correct answer)
- Only the participant's name and dose
- Commercial drug name and manufacturer only
Correct answer: Protocol number, IND number, caution statement, storage conditions, and sponsor contact
FDA 21 CFR 312.6 requires IP labels to include a caution statement, protocol number, IND number, and storage conditions at minimum.
Question 3: When comparing a blinded investigational product to a placebo, which accountability principle still applies?
- Accountability is not needed for placebos
- Full accountability for both active and placebo treatments must be maintained (Correct answer)
- Only active drug requires documentation
- Accountability begins only after unblinding
Correct answer: Full accountability for both active and placebo treatments must be maintained
All investigational products, including placebos, require complete accountability records regardless of blinding status.
Question 4: What is the role of a sponsor-designated pharmacist or designee in investigational product oversight?
- To conduct participant recruitment
- To oversee IP storage, dispensing, and accountability at the site (Correct answer)
- To perform statistical analysis
- To write the study protocol
Correct answer: To oversee IP storage, dispensing, and accountability at the site
A site pharmacist or qualified designee manages IP handling, including inventory control, dispensing records, and compliance with storage requirements.
Question 5: What should happen if the investigational product temperature excursion is discovered at a clinical trial site?
- Discard the product and reorder without documentation
- Document the excursion, quarantine the affected IP, and notify the sponsor immediately (Correct answer)
- Continue using the product if only slightly out of range
- Report to the FDA directly without notifying the sponsor
Correct answer: Document the excursion, quarantine the affected IP, and notify the sponsor immediately
Temperature excursions require immediate quarantine of affected IP, documentation, and sponsor notification to assess usability.
Question 6: How long must investigational product accountability records be retained after the completion of a clinical trial in the US?
- 1 year
- 2 years after the study ends or after NDA/BLA approval, whichever is longer (Correct answer)
- 5 years minimum
- Until the next FDA audit only
Correct answer: 2 years after the study ends or after NDA/BLA approval, whichever is longer
Per 21 CFR 312.62, IP accountability records must be retained for 2 years after study completion or NDA/BLA approval, whichever is later.
ACRP ACRP Investigational Product Management 2
What is an IP dispensing error and how should it be handled in a clinical trial?