SOCRA - Society of Clinical Research Associates ICH Good Clinical Practice Questions and Answers 3

Question 1

What is the significance of ICH E6(R2) vs the original?

Accepted Answer

R2 introduced risk-based monitoring, quality management, and updated electronic records requirements

Answer

R2 introduced risk-based monitoring, quality management, updated electronic records requirements, and proportionate risk-based approaches.

Question 2

What are investigator consent obligations per ICH E6?

Accepted Answer

Must personally ensure adequate consent is freely given before and throughout the study

Answer

Per Section 4.8, the investigator must obtain consent before trial activities, ensure understanding, and update consent as needed.

Question 3

What are GCP data handling and record keeping requirements?

Accepted Answer

All data must be recorded, handled, and stored to allow accurate reporting, interpretation, verification per data integrity standards

Answer

ICH E6 requires accurate recording, handling, and storage enabling reporting, interpretation, and verification while maintaining integrity.

Question 4

How should emergency use of investigational product be handled?

Accepted Answer

FDA allows emergency use when no alternatives exist, requiring retrospective IRB notification and IND reporting

Answer

Per 21 CFR 312.310, emergency use is permitted when no comparable alternatives exist, with retrospective IRB notification within 5 days.

Question 5

What are CRO responsibilities under ICH-GCP?

Accepted Answer

CROs accepting delegated duties assume the same obligations as the sponsor for those duties

Answer

Per Section 5.2, CROs assume sponsor obligations for delegated duties, though the sponsor retains ultimate responsibility.

(SOCRA) Society of Clinical Research Associates Practice Test