CTA Trial Procedures 3

Question 1

What is the primary purpose of source data verification (SDV) during a monitoring visit?

Accepted Answer

To confirm that data recorded in the CRF accurately reflects the original source documents

Answer

SDV ensures that CRF data accurately reflects source documents, maintaining data integrity and regulatory compliance.

Question 2

Which GCP principle requires that clinical trial data be attributable, legible, contemporaneous, original, and accurate?

Accepted Answer

The ALCOA principle

Answer

The ALCOA principle (Attributable, Legible, Contemporaneous, Original, Accurate) defines the required qualities for clinical trial data.

Question 3

A clinical trial subject reports a new medication they started taking. What is the CTA's first responsibility?

Accepted Answer

Record the concomitant medication in the subject's trial records and assess potential interactions per protocol

Answer

Concomitant medications must be documented in trial records and evaluated for protocol compliance and potential interactions.

Question 4

What is the standard requirement for retaining essential documents after the completion of a clinical trial under ICH E6?

Accepted Answer

At least 2 years after the last approval of a marketing application or at least 2 years after formal discontinuation

Answer

ICH E6 requires essential documents to be retained for at least 2 years after the last marketing application approval or 2 years after formal discontinuation.

Question 5

During a clinical trial, an investigator wants to make a change to the protocol before receiving sponsor and IRB approval. What should the CTA advise?

Accepted Answer

The change cannot be implemented until the sponsor approves an amendment and the IRB approves the change

Answer

Protocol changes require sponsor and IRB/ethics committee approval before implementation, except in cases of immediate safety concerns.

(CTA) Clinical Trial Associate Certification Practice Test

(CTA) Clinical Trial Associate Certification Practice Test

CTA Trial Procedures 3