ICH Harmonised Guideline for GCP E6(R2)

Question 1

What is ICH GCP E6(R2)?

Answer 1

A set of international ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials.

Question 2

What is the purpose of ICH GCP E6(R2)?

Answer 2

To ensure the rights, safety, and well-being of trial participants are protected and that trial data is credible and accurate.

Question 3

What are the key principles of ICH GCP E6(R2)?

Answer 3

• Clinical trials must follow ethical principles based on the Declaration of Helsinki.
• Risks must be minimized, and benefits must outweigh potential risks.
• Rights, safety, and well-being of participants must take priority.
• Trial information must be scientifically sound and clearly described.

Question 4

What are the investigator’s responsibilities under ICH GCP E6(R2)?

Answer 4

• Obtain informed consent from participants.
• Ensure the trial is conducted according to the protocol.
• Maintain accurate records and report data properly.
• Ensure participant safety and report adverse events promptly.

Question 5

What are the sponsor’s responsibilities under ICH GCP E6(R2)?

Answer 5

• Design and manage the trial according to GCP standards.
• Ensure data integrity and provide oversight for the trial.
• Monitor trial progress and address any risks or issues.
• Ensure the Investigator’s Brochure (IB) is up-to-date.

Question 6

What are the IRB/IEC responsibilities under ICH GCP E6(R2)?

Answer 6

• Review and approve the trial protocol.
• Ensure participant safety by evaluating risks and benefits.
• Monitor ongoing trials and review any amendments.

Question 7

What is required for informed consent under ICH GCP E6(R2)?

Answer 7

Participants must be informed about:
- The trial’s purpose, risks, and benefits.
- Their right to withdraw at any time.
- The confidentiality of their data.
- Any potential costs or compensation.

Question 8

What is a Trial Master File (TMF)?

Answer 8

A collection of essential documents that show the trial was conducted according to GCP standards and regulatory requirements.

Question 9

What updates were introduced in ICH GCP E6(R2)?

Answer 9

• Emphasis on risk management in trial design and conduct.
• Improved oversight by sponsors.
• Greater focus on data integrity and electronic records.
• Enhanced investigator responsibilities for ensuring participant safety.

Question 10

Why is ICH GCP E6(R2) important?

Answer 10

It ensures clinical trials are conducted ethically, safely, and with reliable data that supports regulatory decisions.