Good Clinical Practice for Laboratories
Best practices for labs analysing samples from clinical trials
by Professor David Hutchinson & Sharon Jordan
This guide is ideal for laboratory staff needing an insight into GCP requirements, as well as sponsors’ monitors, medical experts and auditors who utilise laboratory services in clinical trials.
Guidelines for laboratories involved in the analysis of clinical trial samples have been developed by a number of international organisations in order to set standards for laboratories that lead to reliable and accurately reported data.
This easy-to-read guide is based on the guidance given in the European Medicines Agency’s ‘Reflection Paper for Laboratories that Perform the Analysis or Evaluation of Clinical Trial Samples’, which was adopted by the Good Clinical Practice Inspectors Working Group in 2012.
The guide covers the most important aspects in the Reflection Paper and offers practical advice on how and when a laboratory should comply.