CATO Associate Ethics & Good Clinical Practice (GCP)

Question 1

What is the primary focus of Good Clinical Practice (GCP)?

Accepted Answer

Protect participants and ensure data quality

Answer

GCP provides a framework to protect the rights, safety, and well-being of clinical trial participants and ensures credible data.

Question 2

Which of the following is a core ethical principle in clinical research?

Accepted Answer

Respect for persons

Answer

Respect for persons includes informed consent, acknowledging autonomy, and protecting those with diminished autonomy.

Question 3

Why must informed consent be obtained before trial participation?

Accepted Answer

To ensure voluntary, informed participation

Answer

Informed consent ensures that participants voluntarily agree to join the study with full knowledge of risks and benefits.

Question 4

What does the Declaration of Helsinki provide?

Accepted Answer

Ethical principles for medical research

Answer

This document outlines ethical principles for medical research involving human subjects, developed by the World Medical Association.

Question 5

What role does the IRB play in ethical oversight?

Accepted Answer

Reviews studies for ethical compliance

Answer

The IRB reviews research proposals to ensure the protection of participants’ rights and welfare.

(CCA) CATO Certified Associate Practice Test