Clinical research is mainly conducted world over on good clinical practice principles as outlined in the ICH GCP Guidance.
This is a tripartite guidance accepted by USA, Europe and Japan.
This is a tripartite guidance accepted by USA, Europe and Japan.
There are 13 principles outlined in the E6 guidance of ICH-GCP.ICH GCP is the international conference on harmonisation of technical requirements for registration of pharmaceutical products.The 13 principles are as follows:1. Clinical research based on ethical principles: 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. Risk benefit analysis: 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.3. Rights , safety and well being of subjects: The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society4. Adequate data to support study: The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.5. Clinical trials should be scientifically sound, and described in a clear, detailed protocol.6. Compliance to protocol: trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion7.Qualified physician: 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.8. Qualification of individuals involved: Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).9. Informed consent: Freely given informed consent should be obtained from every subject prior to clinical trial participation10. Data collection: All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.11. Confedentiality of records: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).12. GMP: 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. 13. Quality assurance: Systems with procedures that assure the quality of every aspect of the trial should be implemented.
