Reference:ICH ICH E6 Guideline R3 (2025) II
From GxPlex
| Document information | |
|---|---|
| Reference | ICH ICH E6 Guideline R3 (2025) |
| Validity area | ICH |
| Scope(s) | HM |
| Document name | ICH E6 Guideline |
| Version / Revision | R3 (2025) |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | GUIDELINE FOR GOOD CLINICAL PRACTICE |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 1 — Unit 1.1.4 |
| Scope | G |
| Document part | II |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Good clinical practice, Fundamentals, Ethics, Benefit-risk, Medical care |
Content
II. PRINCIPLES OF ICH GCP [...] 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 applicable regulatory requirement(s). Clinical trials should be designed and conducted in ways that ensure the rights, safety and well-being of participants. 1.1The rights, safety and well-being of the participants are the most important considerations and should prevail over interests of science and society. [...] 1.3Foreseeable risks and inconveniences should be weighed against the anticipated benefits for the individual participants and society. A trial should be initiated and continued only if the anticipated benefits justify the known and anticipated risks. [...] 1.5 A qualified physician or, when appropriate, a qualified dentist (or other qualified healthcare professionals in accordance with local regulatory requirements) should have the overall responsibility for the trial-related medical care given to and medical decisions made on behalf of participants; however, the practical interactions and the delivery of medical care and decisions can be carried out by appropriately qualified healthcare professionals in accordance with applicable regulatory requirements. 1.6 The confidentiality of information that could identify participants should be protected in accordance with applicable privacy and data protection requirements.
2. Informed consent is an integral feature of the ethical conduct of a trial. Clinical trial participation should be voluntary and based on a consent process that ensures participants (or their legally acceptable representatives, where applicable) are well-informed. […]
3. Clinical trials should be subject to an independent review by an IRB/IEC. [...]
4.Clinical trials should be scientifically sound for their intended purpose and based on adequate and current scientific knowledge and approaches. 4.1 The available nonclinical and clinical information on an investigational product(s) should be adequate to support the proposed clinical trial. [...]
5. Clinical trials should be designed and conducted by qualified individuals. [...]
6. Quality should be built into the scientific and operational design and conduct of clinical trials. [...]
7. Clinical trial processes, measures and approaches should be implemented in a way that is proportionate to the risks to participants and to the importance of the data collected and that avoids unnecessary burden on participants and investigators. 7.1 Trial processes should be proportionate to the risks inherent in the trial and the importance of the information collected. Risks in this context include risks to the rights, safety and well-being of trial participants as well as risks to the reliability of the trial results. [...]
8. Clinical trials should be described in a clear, concise, scientifically sound and operationally feasible protocol. [...]
9. Clinical trials should generate reliable results. [...] 9.4 Clinical trials should incorporate efficient and robust processes for managing records (including data) to help ensure that record integrity and traceability are maintained and that personal information is protected, thereby allowing the accurate reporting, interpretation and verification of the relevant clinical trial-related information. [...]
10. Roles and responsibilities in clinical trials should be clear and documented appropriately. [...]
11. Investigational products used in a clinical trial should be manufactured in accordance with applicable Good Manufacturing Practice (GMP) standards and be managed in accordance with the product specifications and the trial protocol. [...]
