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

Increase trial speed

Answer

Ensure marketing effectiveness

Answer

Train sponsors

Question 2

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

Accepted Answer

Respect for persons

Answer

Minimizing paperwork

Answer

Reducing protocol length

Answer

Speeding up trials

Question 3

Why must informed consent be obtained before trial participation?

Accepted Answer

To ensure voluntary, informed participation

Answer

To satisfy insurance providers

Answer

To meet sponsor deadlines

Answer

To replace IRB approval

Question 4

What does the Declaration of Helsinki provide?

Accepted Answer

Ethical principles for medical research

Answer

Budget planning guidance

Answer

Marketing strategies

Answer

Participant recruitment ads

Question 5

What role does the IRB play in ethical oversight?

Accepted Answer

Reviews studies for ethical compliance

Answer

Designs study protocols

Answer

Conducts trial audits

Answer

Analyzes lab data

Question 6

Which document affirms compliance with GCP and ethical conduct?

Accepted Answer

Form 1572

Answer

DSMB log

Answer

Monitoring visit report

Answer

Case report form