- International Conference on Harmonisation Good Clinical Practice Guidelines | CRACONNECTION.COM
- 3. Institutional Review Board/Independent Ethics Committee
- 4. Clinical/Principal Investigator
- 5. Clinical Trial Sponsor | CRACONNECTION.COM
- 6. Clinical Trial Protocol & Amendments
- 7. The Investigator Brochure (IB)
- 7.4 Investigator Brochure Sample (Appendix)
- 8. Essential Documents for the Conduct of Clinical Trials
- All Pages
International Conference on Harmonization Good Clinical Practice (GCP) ICH E6 (R1) Guidelines
Below you will find the text of the ICH GCP Guidelines. We have omitted some section in order to stay on the side of brevity. The table of contents and terms definition have been omittted, in addition to Essential Documents for the conduct of clinical trials. Please to the ICH website at http://www.ich.org for those omitted sections.
2. THE PRINCIPLES OF ICH GCP
2.1 Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
2.2 Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
2.3 The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
2.4 The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
2.5 Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
2.6 A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion.
2.7 The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
2.8 Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
2.9 Freely given informed consent should be obtained from every subject prior to clinical trial participation.
2.10 All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.
2.11 The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
2.12 Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.
2.13 Systems with procedures that assure the quality of every aspect of the trial should be implemented.