CATO Associate Ethics & Good Clinical Practice (GCP) 1 — Questions and Answers
Question 1: What is the primary focus of Good Clinical Practice (GCP)?
- Increase trial speed
- Ensure marketing effectiveness
- Protect participants and ensure data quality (Correct answer)
- Train sponsors
Correct answer: Protect participants and ensure data quality
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?
- Minimizing paperwork
- Respect for persons (Correct answer)
- Reducing protocol length
- Speeding up trials
Correct answer: Respect for persons
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?
- To satisfy insurance providers
- To meet sponsor deadlines
- To ensure voluntary, informed participation (Correct answer)
- To replace IRB approval
Correct answer: To ensure voluntary, informed participation
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?
- Budget planning guidance
- Marketing strategies
- Ethical principles for medical research (Correct answer)
- Participant recruitment ads
Correct answer: Ethical principles for medical research
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?
- Designs study protocols
- Conducts trial audits
- Reviews studies for ethical compliance (Correct answer)
- Analyzes lab data
Correct answer: Reviews studies for ethical compliance
The IRB reviews research proposals to ensure the protection of participants’ rights and welfare.
Question 6: Which document affirms compliance with GCP and ethical conduct?
- DSMB log
- Form 1572 (Correct answer)
- Monitoring visit report
- Case report form
Correct answer: Form 1572
The investigator’s signed Form 1572 confirms adherence to GCP guidelines and regulatory requirements.
CATO Associate Ethics & Good Clinical Practice (GCP) 1
What is the primary focus of Good Clinical Practice (GCP)?