CRM Investigational Product Management 1 — Questions and Answers
Question 1: Which federal regulation governs the accountability and handling of investigational drugs in clinical trials in the United States?
- 21 CFR Part 312 (Correct answer)
- 45 CFR Part 46
- 21 CFR Part 11
- ICH E6 R2
Correct answer: 21 CFR Part 312
21 CFR Part 312 establishes FDA requirements for Investigational New Drug (IND) applications, including investigational product accountability and handling.
Question 2: What document is used to track the receipt, dispensing, return, and destruction of investigational product at a clinical trial site?
- Drug Accountability Log (Correct answer)
- Adverse Event Form
- Protocol Deviation Report
- Informed Consent Form
Correct answer: Drug Accountability Log
A Drug Accountability Log (also called IP Accountability Log) records all movements of investigational product including receipt, dispensing, returns, and destruction.
Question 3: Who is typically responsible for maintaining investigational product accountability records at a clinical trial site?
- Sponsor's medical monitor
- Site pharmacist or designated investigator (Correct answer)
- IRB coordinator
- FDA inspector
Correct answer: Site pharmacist or designated investigator
The site pharmacist or the principal investigator (or their designee) is responsible for maintaining IP accountability records per ICH GCP and FDA regulations.
Question 4: What is the required temperature range for storing most standard investigational biologics that must be refrigerated?
- −20°C to −15°C
- 2°C to 8°C (Correct answer)
- 15°C to 25°C
- 30°C to 40°C
Correct answer: 2°C to 8°C
Refrigerated biologics and many investigational drugs require storage between 2°C and 8°C to maintain product integrity and potency.
Question 5: When an investigational product is dispensed to a subject who later withdraws from the study, the unused product should be:
- Discarded immediately by the subject
- Returned to the site and documented in the accountability log (Correct answer)
- Donated to another enrolled subject
- Sent directly back to the sponsor without logging
Correct answer: Returned to the site and documented in the accountability log
Unused investigational product must be returned to the site and documented in the accountability log to maintain accurate inventory records and chain of custody.
Question 6: A temperature excursion is discovered in the investigational product storage area. What is the FIRST action a Clinical Research Manager should take?
- Destroy the affected product immediately
- Notify the sponsor and document the excursion per protocol (Correct answer)
- Dispense the product before further degradation
- Transfer product to another freezer without reporting
Correct answer: Notify the sponsor and document the excursion per protocol
The first action is to notify the sponsor and document the excursion; the sponsor will then assess product integrity and provide guidance on whether the product remains usable.
Question 7: Which GCP guideline requires that investigational products be manufactured, handled, and stored in accordance with Good Manufacturing Practice (GMP)?
- ICH E3
- ICH E6 (R2) (Correct answer)
- ICH E9
- ICH E2A
Correct answer: ICH E6 (R2)
ICH E6 (R2) — the GCP guideline — requires that investigational products be manufactured and handled in accordance with GMP to ensure quality and integrity.
CRM Investigational Product Management 1
Which federal regulation governs the accountability and handling of investigational drugs in clinical trials in the United States?