Investigational Product Management Flashcards
7 cards from real SOCRA CCRP 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 purpose of investigational product reconciliation at the end of a clinical trial?
Answer: To verify that all IP received, dispensed, and returned or destroyed is fully accounted for
IP reconciliation at study close-out ensures that every unit of investigational product is fully accounted for from receipt through final disposition.
Who has authority to authorize continued use of investigational product that experienced a storage temperature excursion?
Answer: The sponsor, after evaluating the impact of the excursion on product quality
Only the sponsor can assess whether a temperature excursion renders IP unsuitable for use and authorize continued use or quarantine of affected product.
In a multi-site clinical trial, which document typically specifies how investigational product will be allocated and distributed to each participating site?
Answer: The IP Management Plan or drug supply plan provided by the sponsor
The sponsor's IP Management Plan or drug supply plan outlines allocation, shipping, handling, and management of IP across all participating sites.
When dispensing investigational product to a trial subject, which step is MOST critical to prevent medication errors?
Answer: Confirming the subject's randomization number, scheduled visit, and prescribed dose against the protocol
Verifying the randomization number, visit schedule, and dose against the protocol at each dispensing event prevents errors and ensures protocol compliance.
What action should be taken if an investigational product lot is recalled by the sponsor during an ongoing clinical trial?
Answer: Immediately quarantine the recalled lot and follow sponsor instructions for return or destruction
A recalled lot must be immediately quarantined and handled per sponsor recall instructions, with subject safety and accountability as the primary concerns.
Which U.S. federal regulation specifically governs the labeling requirements for investigational new drugs (INDs)?
Answer: 21 CFR Part 312
21 CFR Part 312 governs the IND application process in the US, including labeling requirements for investigational new drugs used in clinical trials.
A CRC discovers that a subject was accidentally dispensed another subject's investigational product. What is the priority FIRST step?
Answer: Immediately assess the affected subject's safety and document the error as a protocol deviation and potential adverse event
The immediate safety of the affected subject is the priority; the dispensing error must be assessed for safety implications and documented as a protocol deviation.