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ICH GCP Key Principles

The ICH-GCP Guidelines (E6 R2) outline key principles for conducting ethical and scientifically sound clinical trials, emphasizing the protection of participant rights and safety. Essential components include informed consent, risk-benefit assessment, compliance with protocols, and maintaining data integrity. Additionally, the guidelines stress the importance of qualified personnel, confidentiality, and quality assurance in trial processes.

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158 views2 pages

ICH GCP Key Principles

The ICH-GCP Guidelines (E6 R2) outline key principles for conducting ethical and scientifically sound clinical trials, emphasizing the protection of participant rights and safety. Essential components include informed consent, risk-benefit assessment, compliance with protocols, and maintaining data integrity. Additionally, the guidelines stress the importance of qualified personnel, confidentiality, and quality assurance in trial processes.

Uploaded by

fizz4530
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Key Principles of ICH-GCP Guidelines (E6 R2)

1. Ethical Conduct

Clinical trials should be conducted in accordance with the Declaration of Helsinki and ensure the rights,

safety, and well-being of participants are protected. Ethical review by an Independent Ethics Committee

(IEC)/Institutional Review Board (IRB) is mandatory.

2. Risk vs. Benefit

The anticipated benefits should justify the risks. Risk should be minimized by sound trial design and

monitoring.

3. Subject Rights, Safety, and Well-being

These take precedence over the interests of science and society. Informed consent and the right to withdraw

are crucial components.

4. Adequate Nonclinical and Clinical Information

Prior to initiating a clinical trial, adequate data from preclinical studies should support the rationale for the

study in humans.

5. Scientifically Sound Protocol

The trial must be based on a scientifically and ethically justified protocol. It should clearly define objectives,

endpoints, design, and statistical analysis.

6. Compliance with Protocol

All clinical trial activities must follow the protocol approved by the ethics committee and regulatory authority.

Amendments must be pre-approved unless they are made for immediate hazard removal.

7. Medical Care and Qualified Personnel

Qualified medical professionals (physicians or dentists) should be responsible for medical decisions during

the trial.
Key Principles of ICH-GCP Guidelines (E6 R2)

8. Informed Consent

Voluntary, informed consent must be obtained from every participant before any trial-related procedure.

Consent should be documented and re-consented if changes occur.

9. Confidentiality of Records

Subject confidentiality must be protected. Records that identify participants should be kept confidential and

comply with data protection regulations.

10. Good Manufacturing Practice (GMP) for Investigational Products

Investigational products should be manufactured, handled, and stored in accordance with GMP and used per

approved protocol.

11. Quality Assurance and Quality Control

Systems with procedures that ensure the quality of every aspect of the trial must be implemented, including

monitoring, auditing, and data verification.

12. Data Integrity and Accurate Reporting

Data should be recorded, handled, and stored in a way that allows accurate reporting, interpretation, and

verification. Source data should be accessible and verifiable.

13. Confidentiality and Record Retention

Essential documents should be retained to allow for verification and audits by regulatory bodies. Records

must be stored securely and retained for a period defined by regulation.

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