Good Clinical Laboratory Practice Booklet

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An International Quality System for Laboratories which undertake the analysis of samples from clinical trials.

This guideline was originally produced in 2002 with the purpose of providing guidance on the quality system required in laboratories that undertake the analysis of samples from clinical trials. Since that time, this guidance has been widely adopted internationally by many organisations such as the World Health Organisation (WHO), pharmaceutical companies, research institutions, non-governmental organisations (NGOs), hospitals, contract research organisations (CROs) and academia.

This document is primarily an update of the original GCLP guideline. Many of the changes made are cosmetic, but others are influenced by the authors' experiences gained in the application of GCLP in many different laboratory settings and trials around the world. In addition, an increasing number of regulatory audits have included those laboratories involved in the support of clinical trials and, as a result of these audits, the general expectations for laboratories have to some degree been clarified. These expectations have also been reflected within this revision of the GCLP Guideline. In all cases it is believed that the changes made only clarify the earlier guidance whilst enhancing patient safety and data integrity.

Contents

1. Preface
2. Scope
3. Introduction
4. Definitions
5. Organisation and Personnel
6. Facilities
7. Equipment, materials and reagents
8. Standard Operating Procedures (SOPs)
9. Planning of the Work
10. Sub-Contracting
11. Trial Materials
12. Conduct of the Work
13. Reporting Results
14. Quality Control
15. Quality Audit
16. Retention and Archiving of Records
17. Confidentiality
18. Blinding
19. Patient Safety

Authors

Tim Stiles and Vanessa Grant

ISBN

978-1-904610-21-2

Published

January 2012, reprinted December 2012

 

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