Good Clinical Practices implementation

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. 

The rules governing clinical trials in the United Kingdom are now set out in the Medicines for Human Use (Clinical Trials) Regulations 2004, which implement Directive 2001/20/EC on good clinical practice in the conduct of clinical trials. 

This Directive establishes specific provisions regarding the conduct of clinical trials, including multi-centre trials, on human subjects involving medicinal products as defined in Article 1 of Directive 65/65/EEC, in particular relating to the implementation of good clinical practice. This Directive does not apply to non-interventional trials. 

Any new medicine needs to be submitted to clinical trials to determine its safety and efficacy. Clinical research with humans must meet the ethical and scientific criteria defined in Good Clinical Practices (GCP) (ICH, 1996c). Adherence to the GCP guarantees a trial design of high quality, its implementation, and appropriate divulgence of the results, thus assuring... 

Good Clinical Practice (GCP) The standard by which clinical trials are designed, implemented and reported so that there is public assurance that the data are credible, and that the rights, integrity, and confidentiality of subjects are protected. [Defined for this book.]... 

Based on Step 4 of the ICH Good Clinical Practice (GCP) guideline of May 1996, the Japanese Ministry of Health and Welfare (MHW) prepared an amendment to the previous GCP guideline and on 27 March 1997 this was issued as MHW Ordinance of the Standards for Good Clinical Practice . This new GCP became effective as of 1 April 1997 with some moratoria (preparation of standard operating procedures (SOP) at medical institutes, source data verification, etc.), and full implementation was from 1 April 1998. Unlike the previous GCP guidelines, the new GCP is based on the revised Pharmaceutical Affairs Law of June 1996, which requires... 

Good Clinical Practice Journal (GCP Journal). 1994-. Richmond, Surrey, UK PJB Publications. Monthly. Articles in this journal focus on identifying and clarifying compliance issues and on assisting with interpretation and implementation of national and international regulations that affect global clinical trials. 

Detailed guidelines on the qualifications of inspectors who should verify compliance in clinical trials with the provisions of good clinical practice for an investigational medicinal product to implement the directive on Clinical Trials on medicinal products for human use. June 2002. http //pharmacos.eudra.org./F2/%20pharmacos/docs/Doc2002/june/ins gcp 06 2002.pdf. 

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