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ready WHO Guideline for Good Clinical Practice

Abbreviation: WHO GCP


General Information

Homepage https://apps.who.int/medicinedocs/en/m/abstract/Js22154en/

Countries that developed this resource Worldwide

Published in 1993

Type: Society

Description:

Good Clinical Practice (GCP) 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. The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. The guideline was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organization (WHO).

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Record added: April 9, 2020, 11:10 a.m. Record updated: April 9, 2020, 11:10 a.m. by The FAIRsharing Team.



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