Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. Compliance with GCP provides public assurance that the rights, safety, and well-being of trial participants are protected.
Originally developed by the International Council for Harmonisation (ICH), GCP guidelines are now recognized worldwide as the foundation for ethical clinical research. These principles ensure that data collected is credible and that participants are treated with dignity and respect.
GCP is built on fundamental principles that guide every aspect of clinical research:
The rights, safety, and well-being of trial subjects are the most important considerations and should prevail over interests of science and society.
Clinical trials should be scientifically sound and described in clear, detailed protocols that have been approved by an ethics committee.
Each individual involved in conducting a trial should be qualified by education, training, and experience to perform their respective tasks.
Freely given informed consent should be obtained from every subject prior to clinical trial participation, documented appropriately.
Even when conducting observational studies or consumer research (rather than clinical trials), GCP principles provide a valuable framework for ensuring ethical conduct and data quality.
At Reputable Health, we apply GCP principles to our Verified Evidence programs. This means:
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