The 13 Principles of Good Clinical Practice (GCP)Wed, 09/09/2015 - 09:37
GCP is the global standard for conducting research involving human beings. It comprises 13 ethical and scientific quality principles aimed at protecting the safety and well-being of human participants and applies to all clinical investigations, with a particular emphasis on clinical trials of medicinal products and medical devices. It was developed by the regulatory authorities of the EU, Japan, and the US, in a group named the Tripartite International Conference on Harmonization (ICH). The agreement was finalized in 1996, and became effective in 1997. Soon after implementation, the GCP gained international recognition as a benchmark for best practice, becoming a reference for many regulatory agencies around the world while creating local regulations for clinical trials.
- Clinical trials should be conducted in accordance with the ethical principles that originate in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirements.
- 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.
- The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
- The available nonclinical and clinical information on an investigational product should adequately support the proposed clinical trial.
- Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
- A trial should be conducted in compliance with the protocol that has received prior Institutional Review Board (IRB) approval, Independent Ethics Committee (IEC) approval or favorable opinion.
- 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, a qualified dentist.
- Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s).
- Freely given informed consent should be obtained from each subject prior to clinical trial participation.
- All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification.
- 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).
- 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.
- Systems with procedures that assure the quality of every aspect of the trial should be implemented.