CCA CATO Associate Ethics & Good Clinical Practice (GCP) 3

Question 1

A participant in a Phase II oncology trial loses decision-making capacity mid-study. GCP guidance recommends:

Accepted Answer

Obtaining consent from a legally authorized representative to continue

Answer

GCP requires that if a participant loses capacity, a legally authorized representative must provide consent for continued participation.

Question 2

The ICH E6(R2) addendum introduced which major new concept to strengthen GCP oversight?

Accepted Answer

Risk-based quality management (QRM)

Answer

ICH E6(R2) introduced risk-based quality management, requiring sponsors to identify and mitigate critical risks to data quality and participant safety.

Question 3

Which of the following is a sponsor's responsibility under GCP regarding investigational product (IP) accountability?

Accepted Answer

Maintaining systems to track IP receipt, use, return, and destruction at sites

Answer

Sponsors must maintain drug accountability systems covering IP shipment, receipt, dispensing, return, and destruction at all trial sites.

Question 4

A CRO contracted by a sponsor defaults on its GCP obligations. Ultimate regulatory responsibility for trial quality remains with:

Accepted Answer

The sponsor

Answer

GCP stipulates that while a sponsor may transfer duties to a CRO, the sponsor retains ultimate regulatory responsibility for the trial.

Question 5

An investigator receives a protocol deviation report from a monitor. Under GCP, the investigator must:

Accepted Answer

Document the deviation, assess impact, and implement corrective actions

Answer

GCP requires investigators to document all deviations, evaluate their impact on participant safety and data integrity, and implement CAPA as needed.

(CCA) CATO Certified Associate Practice Test

(CCA) CATO Certified Associate Practice Test

CCA CATO Associate Ethics & Good Clinical Practice (GCP) 3