CATO Associate Investigational Product Management Flashcards

What document accompanies each shipment of investigational product (IP) to a clinical site?

Answer: Drug shipment manifest / packing slip

A drug shipment manifest or packing slip accompanies each IP shipment to verify contents, quantities, and storage conditions.

Which document is used at a clinical site to record the dispensing, administration, and return of investigational product for each subject?

Answer: Drug Accountability Log

The Drug Accountability Log tracks all IP transactions including receipt, dispensing, administration, and returns at the site level.

What is the term for investigational product that has been returned unused by subjects or retrieved after trial completion?

Answer: Returned IP

Unused IP returned by subjects or retrieved at close-out is termed 'returned IP' and must be documented and managed per sponsor instructions.

Who is responsible for ensuring investigational product at the site is stored according to protocol-specified conditions?

Answer: The Principal Investigator / site pharmacist

The PI (often delegating to the site pharmacist) is responsible for ensuring IP is stored under the conditions specified in the protocol and IB.

What action should a site take if the investigational product temperature excursion alarm is triggered during storage?

Answer: Document the excursion and notify the sponsor before using the affected product

Temperature excursions must be documented and the sponsor notified to assess product integrity before the IP can be used on subjects.

In a double-blind randomized trial, who at the site is permitted to know the treatment assignment for a subject before unblinding?

Answer: The unblinded pharmacist or designee managing IP dispensing

In a double-blind design, only the unblinded pharmacist or designated unblinded staff managing IP may know treatment assignment; all other site staff remain blinded.