SOCRA - Society of Clinical Research Associates ICH Good Clinical Practice Questions and Answers 2

Question 1

What are the 13 principles of ICH-GCP Section 2?

Accepted Answer

Fundamental principles including ethical conduct, scientific soundness, participant rights, and data quality

Answer

Drug manufacturing guidelines

Answer

Lab testing requirements

Answer

Phase III principles only

Question 2

What are sponsor monitoring responsibilities per ICH E6(R2)?

Accepted Answer

Must develop monitoring plans, ensure qualified monitors, and verify compliance, data accuracy, and safety

Answer

Not required to monitor

Answer

Only CRO responsibility

Answer

Only monitor drug supply

Question 3

What is the investigator's IP responsibility per ICH-GCP?

Accepted Answer

Ensure proper storage, dispensing, accountability, and return or destruction per protocol

Answer

No responsibility

Answer

Only pharmacist responsible

Answer

Only prescribes

Question 4

What does ICH E6(R2) say about quality management?

Accepted Answer

Sponsors should implement quality management with risk-based approaches for participant protection and data reliability

Answer

Not addressed

Answer

Manufacturing only

Answer

Only FDA inspectors handle quality

Question 5

What are protocol deviation reporting requirements?

Accepted Answer

Investigator must document and report to sponsor, IRB, and regulatory authorities

Answer

Never need reporting

Answer

Only sponsor reports

Answer

Reported at completion

Question 6

How does ICH-GCP define IRB/IEC responsibilities?

Accepted Answer

Protect rights, safety, and well-being by reviewing protocols, consent forms, and investigator qualifications

Answer

No defined role

Answer

Only handles finances

Answer

Oversees manufacturing