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

Delegation log

Answer

IRB approval letter

Answer

Protocol synopsis

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

Investigator Brochure

Answer

Source Document

Answer

Randomization List

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

Expired stock

Answer

Destroyed product

Answer

Back-up supply

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 sponsor's drug supply team

Answer

The IRB/IEC

Answer

The CRO project manager

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

Dispose of the product immediately

Answer

Use the product and note it in the CRF

Answer

Transfer it to a different freezer without documentation

Question 6

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

Accepted Answer

The unblinded pharmacist or designee managing IP dispensing

Answer

The CRA during monitoring visits

Answer

The principal investigator at all times

Answer

Any member of the study team