Overview

"The standard to which clinical trials must conform is called ""Good Clinical Practice"" (GCP). GCP is defined as a standard that ensures adequate protection of subjects participating in clinical trials; furthermore, it ensures that all trial activities and data are meticulously documented and reported. The latest GCP guideline was developed by the International Conference on Harmonization (ICH) and was first published in May 1996. This guideline is based on ethical principles that have their origin in the Declaration of Helsinki (1964, last modified in October 2000). Besides GCP, clinical trials must also comply with the local law of the country where the study is being conducted. This book should be a useful companion for those conducting clinical trials."

Full Product Details

Author:   G. Fortwengel
Publisher:   S Karger AG
Imprint:   S Karger AG
Dimensions:   Width: 21.60cm , Height: 1.30cm , Length: 28.00cm
Weight:   0.500kg
ISBN:  

9783805576550

ISBN 10:   3805576552
Pages:   108
Publication Date:   14 October 2003
Audience:   Professional and scholarly ,  Professional and scholarly ,  Professional & Vocational ,  Postgraduate, Research & Scholarly
Format:   Spiral bound
Publisher's Status:   Active
Availability:   In Print  
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Table of Contents

International Standards Related to Clinical Research; Clinical Research and Ethics Committees; Clinical Study Design; The Study Monitor and the Routine Visit; Clinical study protocol; case report form and its completion; investigator study file; documentation and archiving; study initiation; delegation of duties; subject information and consent; subject recruitment; randomisation and blinding; investigational product; safety in clinical studies; audit and inspections; study closure; clinical study report and publication.

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