GCP

GCP or Good Clinical Practice is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

History

The principles of Good Clinical Practice (GCP) have their roots in the post-World War II Nuremberg Trials. Following the trials, the Nuremberg Code was established in 1947, stating for the first time that "voluntary consent" of the human subject is absolutely essential. The World Medical Association (WMA) further clarified this with the Declaration of Helsinki in 1964.

Principles

The principles of Good Clinical Practice dictate 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).
• 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 be adequate to 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) / independent ethics committee (IEC) approval / favourable 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, of 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 every 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.

See also

• Clinical trial
• Declaration of Helsinki
• Nuremberg Code
• World Medical Association

GCP Resources
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