Good clinical practice

ICH first published the GCP guidelines in 1996 under the "E6" category and was last amended in 2016. ==Legal and regulatory status==

• European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines. • United States: Although ICH GCP guidelines are recommended by the Food and Drug Administration (FDA), they are not statutory in the United States. The National Institutes of Health requires NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials to be trained in Good Clinical Practice. ==ICH GCP overview==

• Glossary • Principles of ICH GCP • Guidelines for: • institutional review board (IRB) / independent ethics committee (IEC) • investigator • trial sponsor (industrial, academic) • clinical trial protocol and protocol amendments • investigator's brochure • essential documents ==Criticism==

GCP has been called 'a less morally authoritative document' than the Declaration of Helsinki, lacking moral principles and guidance in the following areas: • Disclosure of conflict of interest • Public disclosure of study design • Benefit for populations in which research is conducted • Reporting of accurate results and publication of negative findings • Access to treatment after research has been conducted • Restriction of use of placebo in control group where effective alternative treatment is available In the book Bad Pharma, Ben Goldacre mentions these criticisms and notes that the GCP rules "aren't terrible... [they are] more focused on procedures, while Helsinki clearly articulates moral principles". ==See also==