CTA Clinical Practices Guidelines 2

Question 1

According to ICH E6(R2) GCP, what is the primary purpose of a monitoring visit?

Accepted Answer

To verify that the trial is conducted in compliance with the protocol and applicable regulations

Answer

ICH E6(R2) states that monitoring verifies that trial conduct, data recording, and reporting comply with the protocol, SOPs, GCP, and applicable regulatory requirements.

Question 2

Which document defines the acceptable range for a laboratory test value beyond which a clinical trial protocol requires mandatory reporting?

Accepted Answer

The protocol or laboratory reference ranges specified therein

Answer

The protocol specifies clinically significant laboratory ranges and reporting thresholds that sites must follow during the trial.

Question 3

Under GCP, when a protocol deviation occurs at a site, what is the CTA's first responsibility?

Accepted Answer

Document the deviation and report it to the sponsor per the protocol and SOPs

Answer

GCP requires that deviations be documented and reported to the sponsor according to the protocol and applicable SOPs so appropriate corrective action can be taken.

Question 4

What is the key distinction between a protocol deviation and a protocol violation in clinical trials?

Accepted Answer

Violations involve unapproved changes to key design elements; deviations are unintended departures that may or may not affect subject safety or data integrity

Answer

Violations typically refer to departures that affect subject safety or data integrity, while deviations are unintended non-compliances that may be minor, though terminology varies by sponsor and regulation.

Question 5

Which GCP principle requires that all clinical trial information be recorded, handled, and stored to allow accurate reporting, interpretation, and verification?

Accepted Answer

Data integrity

Answer

GCP's data integrity principle ensures that trial records are accurate, complete, and verifiable to support regulatory submissions and scientific conclusions.

(CTA) Clinical Trial Associate Certification Practice Test

(CTA) Clinical Trial Associate Certification Practice Test

CTA Clinical Practices Guidelines 2