´ÜÇົ ¢Æ Not just another GCP handbook: a practical guide to FDA/DHHS requirements GCPj Handbooks
Reference Number: 1-874409-04-8
Publication Date: 01/04/2003
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´ÜÇົ ¢Æ ICH Harmonised Tripartite Guideline for Good Clinical Practice (with EC Directive) GCPj Handbooks
Reference Number: 1-874409-74-9
Publication Date: 01/07/2001
¡á Contains full text of the principles of ICH GCP, the EC Directive 2001/20/EC and the 2000 Declaration of Helsinki ¡á Absolutely essential.
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´ÜÇົ ¢Æ ICH Harmonised Tripartite Guideline for General Considerations for Clinical Trials GCPj Handbooks
Reference Number: 1-874409-91-9
Publication Date: 01/08/1997
¡á The general principles and development methodology is neatly and concisely presented ¡á Full ICH text reproduced in a very readable format.
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´ÜÇົ ¢Æ The Trial Investigator's GCP Handbook GCPj Handbooks
Reference Number: 1-904255-02-7
Publication Date: 06/06/1997
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´ÜÇົ ¢Æ The Trial Investigator's GCP Handbook, German Translation GCPj Handbooks
Reference Number: 1-874409-42-0
Publication Date: 03/04/1997
The German translation of our popular 'The Trial Investigator's GCP Handbook: a practical guide to ICH requirements'.
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´ÜÇົ ¢Æ The Trial Investigator's GCP Handbook, Spanish Translation GCPj Handbooks
Reference Number: 1-874409-54-4
Publication Date: 04/04/2001
The Spanish translation of our popular 'The Trial Investigator's GCP Handbook: a practical guide to ICH requirements'.
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´ÜÇົ ¢Æ ICH Harmonised Tripartite Guideline for Data Elements for Transmission of Individual Case Safety Reports GCPj Handbooks
Reference Number: 1-874409-02-1
Publication Date: 06/09/1997
¡á Guidelines presented in a concise and structured manner
¡á Easy to read with full ICH text transcript.
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´ÜÇົ ¢Æ ICH Harmonised Tripartite Guideline for Statistical Principles for Clinical Trials GCPj Handbooks
Reference Number: 1-874409-07-2
Publication Date: 03/04/1998
¡á Full ICH consideration text
¡á Clearly presented and annotated for easy referencing.
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´ÜÇົ ¢Æ Which Documents, Why? GCPj Handbooks
Reference Number: 1-874409-81-1
Publication Date: 06/05/1997
This book summarises the minimum documentation that is required to ensure conformation to ICH guidelines.
Gives practical advice on how to set up and maintain a trial file at the investigational site.
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´ÜÇົ ¢Æ Help! The GCP Auditor is coming! GCPj Handbooks
Reference Number: 1-874409-96-x
Publication Date: 26/09/1997
¡á This book provides invaluable guidance to investigators who are uncertain of how to deal with a clinical trial audit.
¡á Topics include, the audit timetable, pre-audit checks, dealing with the outcome, common audit and inspection problems.
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´ÜÇົ ¢Æ How Drugs are Developed GCPj Handbooks
Reference Number: 1843114909
Publication Date: 12/12/2005
¡á This book is intended to be a practical guide for those interested in clinical research and good clinical practice who wish to gain more knowledge of these subjects.
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´ÜÇົ ¢Æ Dictionary of Clinical Research GCPj Handbooks
Reference Number: 1843114895
Publication Date: 12/12/2005
¡á This dictionary contains hundreds of abbreviations and terms commonly encountered by personnel working in clinical research. It is an essential desk-side reference for secretaries, clinical research associates and managers.
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´ÜÇົ ¢Æ An Introduction to Health Economics GCPj Handbooks
Reference Number: 1-874409-36-6
Publication Date: 11/01/1995
¡á This book reviews the current status of economic evaluation methods and aims to provide general guidance to healthcare organisations undertaking, or commissioning, economic evaluations of their products. Indeed, this publication is also useful for those needing to review the content and correctness of health economic evaluations.
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´ÜÇົ ¢Æ An FDA Inspector Calls: How to Prepare for an Inspection at Clinical Investigator Sites GCPj Handbooks
Reference Number: 1-904225-03-5
Publication Date: 01/03/2004
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´ÜÇົ ¢Æ 21 CFR Good Manufacturing Practice Guidlines GCPj Handbooks
Reference Number: 1-874409-24-2
Publication Date: 20/06/2003
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´ÜÇົ ¢Æ 21 CFR Devices (parts 803, 812, 814) GCPj Handbooks
Reference Number: 1-874409-09-9
Publication Date: 02/05/2002
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