Investigational Product Management Flashcards
7 cards from real CRM 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 a Certificate of Analysis (CoA) used for in the context of investigational product management?
Answer: To confirm the identity, purity, potency, and quality of the investigational product
A CoA is provided by the manufacturer and confirms the identity, purity, potency, and quality of the investigational product, ensuring it meets required specifications.
At the end of a clinical trial, investigational product that has not been dispensed must typically be:
Answer: Returned to the sponsor or destroyed per protocol and documented
Undispensed IP must be returned to the sponsor or destroyed according to protocol requirements, and all actions must be fully documented in accountability records.
What is 'blinding' in the context of investigational product management?
Answer: A process to conceal the allocation of treatment so subjects or investigators are unaware of treatment assignment
Blinding refers to concealing treatment assignment from subjects, investigators, or both to prevent bias in the assessment of study outcomes.
Which of the following is required on the label of an investigational product shipped to a U.S. clinical trial site?
Answer: A statement such as 'Caution: New Drug — Limited by Federal Law to Investigational Use'
Per 21 CFR Part 312, investigational drug labels must include a statement limiting use to investigational purposes, along with protocol number, lot number, expiration date, and storage conditions.
A randomization schedule in a blinded clinical trial is considered a form of:
Answer: Essential document to be filed in the Trial Master File
The randomization schedule is an essential document that must be filed in the Trial Master File (TMF) because it links treatment allocation to subject identifiers and is critical for data integrity.
What is the purpose of an unblinding procedure in a clinical trial?
Answer: To reveal a specific subject's treatment assignment in emergency medical situations
Emergency unblinding allows a treating physician to learn a specific subject's treatment assignment when the information is necessary for appropriate medical management in an emergency.
Which practice best ensures proper investigational product chain of custody during shipment from sponsor to site?
Answer: Completion of shipping manifests, temperature monitoring logs, and signed receipts
Chain of custody requires documented records including shipping manifests, continuous temperature monitoring logs, and signed receipts to verify product integrity and accountability throughout transit.