international guidelines, including GCP guidelines issued subsequent to , such as the International Conference on Harmonization (ICH). Good Clinical. The purpose of these WHO Guidelines for Good Clinical Practice (GCP) for trials on pharmaceutical products is to set globally applicable standards for the. Page 1. The 13 principles of ICH GCP. Clinical)trials)should)be)conducted)in) accordance)with)the)ethical)principles)that).
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Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials. Addendum to ICH E6(R1). Guidance for Industry. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation. Current effective version. PDF icon Revision 2 - Adopted guideline. Reference number, EMA/CHMP/ICH// Published, 15/12/ Effective from, 14/06/ .
Clinical trials Tags: Safety monitoring and reporting in clinical trials involving therapeutic goods. Compliance with the Guideline is a condition of approval for the conduct of a clinical trial. However, in Australia, the overriding consideration for trial sponsors with respect to record retention is the issue of product liability and the potential need for sponsors of products to produce records at any time during, and possibly beyond, the life of a product in the event of a claim against the sponsor as a result of an adverse outcome associated with the use of the product. The Guideline for Good Clinical Practice is an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials. TGA comment: