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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). [3]
Each clinical practice guideline has been systematically researched, reviewed and revised by the SAGES Guidelines Committee and also evaluated by an appropriate multidisciplinary team. Guidelines are scheduled for periodic review to allow incorporation of pertinent new developments in medical research knowledge, and practice.
The European Forum for Good Clinical Practices (EFGCP) is a European think tank which works on the ethical, regulatory, and scientific framework of clinical research in Europe. The EFGCP is committed to the development of the standards for the protection of human subjects and data quality in clinical trials, both in Europe and abroad.
Owing to the importance of the IB in maintaining the safety of human subjects in clinical trials, and as part of their guidance on good clinical practice (GCP), the U.S. Food and Drug Administration (FDA) has written regulatory codes and guidances for authoring the IB, and the International Conference on Harmonisation (ICH) has prepared a ...
Training and assessment comprises three components, which cover the general practice specialty training curriculum. The Applied Knowledge Test (AKT) is a multiple-choice computer-based assessment that tests the knowledge base underpinning general practice in the UK. It covers clinical medicine, critical appraisal/evidence-based clinical ...
Evidence-based medicine (EBM) is "the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. ...[It] means integrating individual clinical expertise with the best available external clinical evidence from systematic research."
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