Article Text

PDF
Good clinical practice in clinical trials: core knowledge for emergency physicians
  1. Steve Goodacre1,
  2. Tim Coats2,
  3. Michael Clancy3
  1. 1
    University of Sheffield, Sheffield, UK
  2. 2
    University of Leicester, Leicester, UK
  3. 3
    Southampton General Hospital, Southampton, UK
  1. Professor S Goodacre, Medical Care Research Unit, University of Sheffield, Regent Court, 30 Regent Street, Sheffield S1 4DA, UK; s.goodacre{at}sheffield.ac.uk

Statistics from Altmetric.com

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 treatment with good scientific evidence to support it. …

View Full Text

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.