Investigational Product Management Flashcards
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Read the first 7 Investigational Product Management flashcards as text
Which federal regulation governs the accountability and handling of investigational drugs in clinical trials in the United States?
Answer: 21 CFR Part 312
21 CFR Part 312 establishes FDA requirements for Investigational New Drug (IND) applications, including investigational product accountability and handling.
What document is used to track the receipt, dispensing, return, and destruction of investigational product at a clinical trial site?
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.
Who is typically responsible for maintaining investigational product accountability records at a clinical trial site?
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.
What is the required temperature range for storing most standard investigational biologics that must be refrigerated?
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.
When an investigational product is dispensed to a subject who later withdraws from the study, the unused product should be:
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.
A temperature excursion is discovered in the investigational product storage area. What is the FIRST action a Clinical Research Manager should take?
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.
Which GCP guideline requires that investigational products be manufactured, handled, and stored in accordance with Good Manufacturing Practice (GMP)?
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.