COMMENTARIES
Good clinical practice in clinical trials: core knowledge for emergency physicians
1 University of Sheffield, Sheffield, UK
2 University of Leicester, Leicester, UK
3 Southampton General Hospital, Southampton, UK
Correspondence to:
Professor S Goodacre, Medical Care Research Unit, University of Sheffield, Regent Court, 30 Regent Street, Sheffield S1 4DA, UK; s.goodacre@sheffield.ac.uk
Accepted 12 June 2008
| The first 150 words of the full text of this article appear below. |
Good Clinical Practice (GCP) is a set of guidelines agreed at the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use.1 The definition of ICH-GCP is "A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected". Although developed for clinical trials of pharmaceuticals, the principles of ICH-GCP are relevant to most clinical research. Clinicians involved in research, and certainly those involved in clinical trials, are therefore expected to know and understand ICH-GCP. The College of Emergency Medicine Education and Examinations Committee has decided to make ICH-GCP part of the emergency medicine curriculum. This editorial explains the reasoning behind this decision.
Emergency medicine is a science-based specialty. We want to give the best possible
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