Investigational Product Management Flashcards

A sponsor conducts a risk assessment and decides to centralize IP dispensing at a pharmacy hub rather than each site. This approach is best described as:

Answer: Centralized IP management, permissible when validated and compliant with local regulations

Centralized dispensing models are permissible under GCP when properly validated, documented in the protocol, and compliant with applicable pharmacy and regulatory requirements.

What is the significance of lot number documentation in drug accountability records?

Answer: It enables traceability for quality investigations, recalls, or stability issues linked to specific manufacturing batches

Lot numbers link each dispensed unit to a specific manufacturing batch, enabling full traceability for safety investigations, recalls, and stability monitoring.

A subject in a blinded trial is hospitalized, and the treating physician requests the subject's treatment assignment for clinical management. The PI should:

Answer: Follow the protocol's emergency unblinding procedure and document the unblinding event

Emergency unblinding must follow the protocol-defined procedure, be documented in source records and the subject's file, and typically be reported to the sponsor promptly.

Under 21 CFR Part 312, which of the following is the sponsor's responsibility regarding IP shipped to investigator sites?

Answer: Sponsors must ship IP only to investigators under an IND and maintain shipping records

21 CFR 312.50 requires sponsors to ship IP only to qualified investigators holding a valid IND and to maintain complete shipping records for regulatory review.

At study closeout, the site has 12 units of IP remaining. The sponsor instructs the site to return them. What documentation is required?

Answer: A return shipment form documenting quantity, lot numbers, condition, and chain of custody for return to sponsor

IP returns must be documented with a return shipment form capturing lot numbers, quantities, condition, and shipping details to complete the chain of custody.

A site pharmacy is audited and the auditor finds that access to the IP storage area is not restricted. Which GCP principle is violated?

Answer: Controlled access to investigational product to prevent unauthorized use or tampering

GCP requires that IP be stored in a secured, access-controlled area to prevent theft, unauthorized use, or tampering that could compromise subject safety or data integrity.

A CRC notices that a dispensed IP kit was assigned to Subject 007, but the IRT shows Subject 007 should have received Kit 142, not Kit 138 that was actually dispensed. What is the first step?

Answer: Document the dispensing error, notify the PI and sponsor immediately, and assess subject safety implications

Dispensing errors are protocol deviations that must be immediately documented, reported to the PI and sponsor, and evaluated for subject safety and data impact.