CRA Investigational Product Management 2

Question 1

What is an 'emergency code break' in the context of a blinded clinical trial?

Accepted Answer

Unblinding a subject's treatment assignment for medical management

Answer

An emergency code break is the formal process of revealing a blinded subject's treatment assignment when it is medically necessary for the care of that subject.

Question 2

How must unused investigational product typically be handled at study close-out?

Accepted Answer

Returned to the sponsor or destroyed per sponsor instructions with full documentation

Answer

Unused investigational product must be returned to the sponsor or destroyed per sponsor-approved procedures, with complete documentation of all dispositions.

Question 3

What is the primary purpose of a kit number or bottle number on investigational product in a blinded study?

Accepted Answer

To uniquely identify and track each unit of IP while maintaining blinding

Answer

Kit and bottle numbers uniquely identify each unit of investigational product, enabling full accountability and tracking without revealing the treatment assignment in blinded studies.

Question 4

Which US regulation establishes requirements for investigational drug storage, handling, and accountability at clinical trial sites?

Accepted Answer

21 CFR Part 312

Answer

21 CFR Part 312, which governs Investigational New Drug applications, establishes the US regulatory requirements for investigational drug storage, handling, and accountability.

Question 5

What should a site do upon receiving investigational product with visibly damaged or compromised packaging?

Accepted Answer

Document the damage, quarantine the product, and notify the sponsor

Answer

Damaged product must be quarantined to prevent its use, the damage documented, and the sponsor notified so they can assess product integrity before any decision is made.

(CRA) Certified Research Associate Practice Test

(CRA) Certified Research Associate Practice Test

CRA Investigational Product Management 2