ACRP ACRP Investigational Product Management 1 — Questions and Answers
Question 1: Who is primarily responsible for maintaining the investigational product accountability records at a clinical trial site?
- The Principal Investigator (Correct answer)
- The Clinical Research Coordinator
- The Sponsor
- The IRB
Correct answer: The Principal Investigator
The Principal Investigator is ultimately responsible for IP accountability, including storage, dispensing, and return logs per FDA regulations.
Question 2: What document must be completed each time investigational product is dispensed to a study participant?
- Adverse Event Report
- Drug Accountability Log (Correct answer)
- Informed Consent Form
- Case Report Form
Correct answer: Drug Accountability Log
A Drug Accountability Log records each dispensing event, including lot numbers, amounts dispensed, and participant identifiers.
Question 3: Under what conditions must investigational product be stored at a clinical trial site?
- Any convenient location accessible to staff
- Per sponsor protocol and applicable regulations (Correct answer)
- In the general hospital pharmacy
- At room temperature only
Correct answer: Per sponsor protocol and applicable regulations
IP must be stored according to sponsor-specified conditions (temperature, humidity, light) and applicable 21 CFR regulations.
Question 4: What is the purpose of a certificate of analysis (CoA) for investigational product?
- To confirm participant eligibility
- To document IP quality, identity, and potency (Correct answer)
- To authorize IRB approval
- To record adverse events
Correct answer: To document IP quality, identity, and potency
A CoA certifies that the IP batch meets specified quality standards and confirms identity, potency, purity, and safety.
Question 5: What action must be taken with unused investigational product at the end of a clinical trial?
- Dispose of it in regular waste
- Return or destroy per sponsor instructions and document appropriately (Correct answer)
- Keep it for future studies
- Give it to participants
Correct answer: Return or destroy per sponsor instructions and document appropriately
Unused IP must be returned to the sponsor or destroyed per protocol-specified procedures, with full documentation of the disposition.
Question 6: Which temperature monitoring practice is required for investigational products requiring refrigeration?
- Check temperature once weekly
- Use calibrated continuous monitoring with excursion documentation (Correct answer)
- Visual inspection only
- No monitoring required if stored in a standard refrigerator
Correct answer: Use calibrated continuous monitoring with excursion documentation
Continuous, calibrated temperature monitoring with documentation of any excursions ensures IP integrity throughout the trial.
ACRP ACRP Investigational Product Management 1
Who is primarily responsible for maintaining the investigational product accountability records at a clinical trial site?