CCA CATO Associate Investigational Product Management 1 — Questions and Answers
Question 1: What document accompanies each shipment of investigational product (IP) to a clinical site?
- Delegation log
- Drug shipment manifest / packing slip (Correct answer)
- IRB approval letter
- Protocol synopsis
Correct answer: Drug shipment manifest / packing slip
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?
- Investigator Brochure
- Drug Accountability Log (Correct answer)
- Source Document
- Randomization List
Correct answer: Drug Accountability Log
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?
- Expired stock
- Returned IP (Correct answer)
- Destroyed product
- Back-up supply
Correct 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.
Question 4: Who is responsible for ensuring investigational product at the site is stored according to protocol-specified conditions?
- The sponsor's drug supply team
- The IRB/IEC
- The Principal Investigator / site pharmacist (Correct answer)
- The CRO project manager
Correct 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.
Question 5: What action should a site take if the investigational product temperature excursion alarm is triggered during storage?
- Dispose of the product immediately
- Document the excursion and notify the sponsor before using the affected product (Correct answer)
- Use the product and note it in the CRF
- Transfer it to a different freezer without documentation
Correct 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.
Question 6: In a double-blind randomized trial, who at the site is permitted to know the treatment assignment for a subject before unblinding?
- The CRA during monitoring visits
- The principal investigator at all times
- The unblinded pharmacist or designee managing IP dispensing (Correct answer)
- Any member of the study team
Correct 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.
CCA CATO Associate Investigational Product Management 1
What document accompanies each shipment of investigational product (IP) to a clinical site?