The Good Clinical Practice Guide

Online Shop | Books for your Business | Pharmaceutical and Medical Books |  The Good Clinical Practice Guide

The Good Clinical Practice Guide

Free UK delivery on The Good Clinical Practice Guide
The Good Clinical Practice Guide


ISBN: 9780117081079
Author MHRA
Binding: Paperback
Publisher: TSO
Publication Date: September 2012


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.

The Good Clinical Practice Guide 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.

Testimonial:

This is an impressive and detailed overview of clinical trials that will add value to all working in this field on a global basis, not just in the UK. The consistency of style throughout is surprising and welcome. Alec Deighton, Representative of the Association of Clinical Research Organizations (ACRO)


Content of Chapters

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

If you're interested in this, you might also be interested in\n Guidelines for the Blood Transfusion Services in the United Kingdom 8th Edition 2013

£45.00





Related Publications:

Clinical Pharmacy Pocket Companion

Clinical Pharmacy Pocket Companion

Clinical Pharmacokinetics

Clinical Pharmacokinetics

Popular Medicines

Popular Medicines


Online Shop | Books for your Business | Pharmaceutical and Medical Books |  The Good Clinical Practice Guide

Civil Service Yearbook
The new Civil Service Yearbook 53rd Edition - Pre-order now.
Civil Service Yearbook 52nd Edition available now
Buy The Civil Service Yearbook
IMDG Code
2014 Edition
The new IMDG Code is in stock now.
IMDG Code 2014 available now
Buy The IMDG code
New Products

The Report of the Iraq Inquiry

Police Workforce, England and Wales, 30 September 2016

European Pharmacopoeia 9th Edition Book Subscription 2017 (9.0, 9.1 and 9.2)

Fire Statistics: Great Britain, 2014-2015

Non-domestic rating: Business Floorspace 2016

The Annual Abstract of Statistics for Benefits, and Indices of Prices and Earnings 2016 Edition

Annual Bus Statistics Light Rail and Tram Statistics Blue Badge Scheme Statistics 2015/16

Bookmark us via QR code
Worldwide Delivery
Secure Payment
Secure Payment
Best Sellers

Dorema U-tabs for ADR/RID 2017

UN ADR 2017 (Books) Two Volume Set

IMDG Code 2016 Edition (inc Amdt 38-16) Book (2 vols)

HSE Approved Codes of Practice - Six Pack (6 Pack) Pack of 6 Books

IATA Dangerous Goods Regulations (DGR) 58th Edition 2017 (Regular Bound)

IMDG Code 2014 Edition (inc Amdt 37-14) Book (2 vols)