CTA Clinical Practices Guidelines 1

Question 1

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

Accepted Answer

To protect subjects and ensure credible data

Answer

To reduce trial costs

Answer

To increase trial speed

Answer

To approve trial budgets

Question 2

Which guideline defines the standard for clinical trials globally?

Accepted Answer

ICH E6 (R2)

Answer

FDA 21 CFR Part 50

Answer

HIPAA

Answer

EMA Directive 2001/20/EC

Question 3

Who is ultimately responsible for ensuring GCP compliance at a trial site?

Accepted Answer

Principal Investigator

Answer

Clinical trial monitor

Answer

Study participants

Answer

Regulatory authorities

Question 4

Which GCP document outlines roles and responsibilities of clinical trial stakeholders?

Accepted Answer

ICH GCP guideline

Answer

Trial Master File

Answer

Case Report Form

Answer

Informed Consent Form

Question 5

What is required before initiating a clinical trial under GCP?

Accepted Answer

IRB approval and informed consent

Answer

Final CSR report

Answer

Signed monitoring plan

Answer

Budget approval

Question 6

Which element is NOT part of a standard GCP training program?

Accepted Answer

Statistical analysis techniques

Answer

Ethical principles

Answer

Data integrity

Answer

Subject safety

Question 7

Why is it important to follow standard operating procedures (SOPs)?

Accepted Answer

To ensure consistent and compliant trial conduct

Answer

To shorten the trial timeline

Answer

To reduce sponsor responsibilities

Answer

To skip protocol approvals

Question 8

How often should GCP training be updated for clinical staff?

Accepted Answer

Annually or as required by the institution

Answer

Only once

Answer

Every 5 years

Answer

Never, if certified once

Question 9

What should be done if a GCP violation occurs during a trial?

Accepted Answer

Report and document the incident

Answer

Ignore if minor

Answer

Notify media

Answer

Continue without action