Industrielle Praxis

Industrielle Praxis

Medicines and Healthcare products Regulatory Agency

Good Clinical Practice Guide

ISBN 978-3-7692-5984-1

EUR 69,00
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Abstract

The Good Clinical Practice Guide is a brand new publication covering the legislation, guidance and good practice that relates to the conduct of clinical trials of medicinal products for human use in the UK.

Detailed and authoritative, this guide will provide practical advice about implementing the principles of Good Clinical Practice within the context of the clinical trial regulatory framework in the European Union.

Written and produced by the MHRA, this is the only guide on Good Clinical Practice available within Europe which has been produced by a regulatory agency.

This title is aimed at any individual and/or organisation involved in conducting clinical trials with medicines in the UK, including both commercial and non-commercial sponsors and hosts of clinical trials, as well as contract research organisations, clinical research consultants and other niche providers.

The guide references European legislation and guidance as well as international standards, so will also be relevant to organisations conducting trials across Europe and beyond.

Content:

1. Sponsor Oversight
2. Clinical Trial Authorisations
3. Ethical Review
4. Key Trial Documentation
5. Pharmacovigilance for Clinical Trials
6. Investigational Medicinal Products
7. Monitoring
8. Data Management
9. Statistics
10. Trial Master File and Archiving
11. Investigator Sites
12. Phase I Clinical Trials
13. Clinical Trial Samples - Analysis and Evaluation
14. Quality Systems

Annex 1: Introduction to GCP Inspections
Annex 2: Relevant legislation and guidance
Annex 3: Advanced Therapy Investigational Medicinal Product Trials
Annex 4: Considerations for the use of electronic systems in clinical trial management

1st Edition 2012. 542 p.
soft cover

Deutscher Apotheker Verlag