There are 13 key principles of Good Clinical Practice (GCP). The first seven are:
- Adherence to ethical principles
- Risk minimization
- Subject’s rights, safety, and well-being
- Adequate drug information
- Scientifically sound protocols
- IRB/IEC review and approval and protocol adherence
- Involvement of qualified physician
Adherence to Ethical Principles
ICH GCP Principle 1 states that 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).
Risk Minimization
ICH GCP Principle 2 states that 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.
Subject’s Rights, Safety, and Bell-Being
ICH GCP Principle 3 states that the rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
Adequate Drug Information
ICH GCP Principle 4 states that the available non-clinical and clinical information on an investigational medicinal product shall be adequate to support the proposed clinical trial.
Scientifically Sound Protocols
ICH GCP Principle 5 states that clinical trials should be scientifically sound, and described in a clear, detailed protocol.
IRB/IEC Review and Approval and Protocol Adherence
ICH GCP Principle 6 states that a trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favorable opinion.
Involvement of 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.
