ICH guidelines ICH GCP guidelines

ICH guidelines

The rights, safety, and well being of the trial subjects are the most important considerations & should prevail over interests of science and society.

1. The available nonclinical & clinical information on an investigational product should be adequate support the proposed clinical trial.
2. Clinical trials should be scientifically sound, & described in a clear, detailed protocol; which has received prior IRB/IEC approval
3. The medical care and medical decisions for subjects should be the responsibility of a qualified physician
4. Each individual involved in conducting a trial should be qualified by education, training & experience to perform his respective task
5. Freely given informed consent should be obtained from every subject prior to clinical trial participation
6. All clinical information should be recorded, handled, and stored in a way that allows its  accurate reporting, interpretation and verification
7. The confidentiality of records that could identify patients should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirements
8. Investigational products should be manufactured, handled and stored in accordance with applicable GMP, and used in accordance with the protocol
9. Systems with procedures that assure the quality of every aspect of the trial should be implemented

ICH GCP guidelines

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 good clinical practice and the regulatory requirement(s)
2. Before a trial is initiated, foreseeable risks and inconveniences should beweighed 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. The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society
4. The available pre-clinical 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. A trial should be conducted in compliance with the protocol that has received prior Institutional Review Board/Independent Ethics Committee (IRB/IEC) approval/favorable opinion
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
8. Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s)
9. Freely given informed consent should be obtained from every subject prior to clinical trial participation
10. All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification
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)
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
13. Systems with procedures that ensure the quality of every aspect of the trial should be implemented.