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

Section 2 contains 13 principles covering ethical conduct, scientific soundness, participant rights, qualified personnel, consent, and data quality.

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

Section 5.18 requires developing monitoring plans, appointing qualified monitors, and conducting on-site and centralized monitoring.

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

Per Section 4.6, the investigator is responsible for IP accountability including storage, dispensing, documentation, and return.

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

Addendum 5.0 requires quality management including prospective risk identification and risk-based monitoring.

Question 5

What are protocol deviation reporting requirements?

Accepted Answer

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

Answer

Per ICH E6, deviations should not occur without agreement except to eliminate hazards. All must be documented and reported.

(SOCRA) Society of Clinical Research Associates Practice Test