CCA CATO Associate Investigational Product Management

Question 1

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

Accepted Answer

Drug shipment manifest / packing slip

Answer

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

Question 2

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

Accepted Answer

Drug Accountability Log

Answer

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

Question 3

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

Accepted Answer

Returned IP

Answer

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

Question 4

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

Accepted Answer

The Principal Investigator / site pharmacist

Answer

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

Question 5

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

Accepted Answer

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

Answer

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

(CCA) CATO Certified Associate Practice Test