CTA Trial Procedures 2

Question 1

What is the purpose of a Protocol Deviation Report (PDR) in a clinical trial?

Accepted Answer

To document and communicate any departure from the approved protocol

Answer

A PDR documents and communicates any departure from the approved protocol to the sponsor and, when required, to the IRB/ethics committee.

Question 2

During a clinical trial, when should a subject's informed consent be re-obtained?

Accepted Answer

When significant new information becomes available that may affect the subject's willingness to continue

Answer

Re-consent is required whenever significant new information emerges that could affect the subject's willingness to continue participation.

Question 3

What does 'blinding' refer to in the context of randomized controlled trials?

Accepted Answer

Withholding knowledge of treatment assignment from participants and/or investigators

Answer

Blinding (masking) is a procedure where knowledge of the treatment assignment is withheld from subjects, investigators, or both to reduce bias.

Question 4

Which document serves as the primary reference for acceptable laboratory values and normal ranges at a clinical trial site?

Accepted Answer

The site's certified laboratory reference ranges

Answer

The site's certified laboratory normal ranges are used to evaluate whether subject laboratory values are within acceptable limits.

Question 5

What is the role of a Data Safety Monitoring Board (DSMB) in a clinical trial?

Accepted Answer

To independently review accumulating safety and efficacy data and recommend trial continuation, modification, or termination

Answer

A DSMB is an independent committee that monitors accumulating trial data to protect subject safety and ensure trial integrity.

(CTA) Clinical Trial Associate Certification Practice Test