Investigational Product Management Flashcards
7 cards from real CTA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Investigational Product Management flashcards as text
What is the primary purpose of an Investigational Product (IP) accountability log in clinical trials?
Answer: To track receipt, dispensing, return, and destruction of all IP at the site
The IP accountability log provides a complete chain-of-custody record for all investigational product at the site, ensuring every unit is accounted for from receipt through destruction.
According to GCP guidelines, where should investigational products be stored at a clinical trial site?
Answer: In a designated, secure area under conditions specified by the sponsor protocol
GCP requires IP to be stored in a secure, designated area that meets the temperature, humidity, and light conditions specified by the sponsor to maintain product integrity.
What document typically authorizes the shipment of investigational products to a clinical trial site?
Answer: The drug shipment authorization or IP release letter from the sponsor
The sponsor issues an IP release or shipment authorization confirming the site is approved and all necessary regulatory documents are in place before shipping investigational product.
Who is typically responsible for dispensing investigational products to study participants at a clinical site?
Answer: A qualified pharmacist or authorized designee as specified in the protocol
IP dispensing must be performed by a licensed pharmacist or another authorized individual explicitly designated in the protocol or site pharmacy procedures to ensure accurate dosing and documentation.
What is the correct procedure when unused investigational product is returned by a study participant?
Answer: Document the return in the IP accountability log and quarantine per protocol instructions
Returned IP must be logged in the accountability record and quarantined according to protocol; it cannot be re-dispensed unless explicitly permitted, and destruction follows sponsor instructions.
Which regulatory requirement primarily governs the labeling of investigational medicinal products in the United States?
Answer: 21 CFR Part 312 (IND regulations)
21 CFR Part 312 outlines the IND requirements including mandatory labeling elements for investigational drugs, such as the statement 'Caution: New Drug – Limited by Federal law to investigational use.'
What does 'blinding' refer to in the context of investigational product management?
Answer: The process of withholding treatment assignment from participants and/or site staff to minimize bias
Blinding conceals treatment assignment (active drug vs. placebo) from participants and/or investigators to prevent bias in outcome assessment and participant behavior.