Information on the clinical trial of, and research on, medicines and medical devices
The text of the Helsinki Declaration on the Ethical Principles for Medical Research Involving Human Subjects is available from here adopted by the 18th World Medical Association General Assembly in Helsinki, Finland, June 1964, and as last amended by the 52nd World Medical Association General Assembly, Edinburgh, Scotland, October 2000.
The Guidelines on Good Clinical Practice (GCP) (CPMP/ICH1135/95) on trials involving the participation of humans is published by the European Agency for the Evaluation of Medicinal Products and can be downloaded in pdf format.
The Guidelines on Good Clinical Practice (GCP) “are an international 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 trials are credible. The objective of the [GCP Guidelines] is to provide a unified standard for the European Union, Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.”
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