Handbook for good clinical research practice (GCP) guidance for implementation by World Health Organization

Cover of: Handbook for good clinical research practice (GCP) | World Health Organization

Published by World Health Organization in Geneva, Switzerland .

Written in English

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Subjects:

  • Clinical medicine,
  • Standards

Edition Notes

Includes bibliographical references.

Book details

The Physical Object
Format[electronic resource] :
ID Numbers
Open LibraryOL25544224M
ISBN 10924159392X
ISBN 109789241593922
OCLC/WorldCa225022968

Download Handbook for good clinical research practice (GCP)

Tively referred to as “Good Clinical Research Practice” (GCP). This handbook is issued as an adjunct to WHO’s “Guidelines for good clinical practice (GCP) for trials on pharmaceutical products” (), and is intended to assist national regulatory authorities, sponsors, investigators and ethics committees in implementing GCP for industry.

1. Basic Principles of Clinical Research and Methodology - SK Gupta 2. By ICRI - Institute of Clinical Research Of INDIA 3. Fundamentals of Clinical Trial - Lawrence M. Friedman 4. key topics - study design, blindness, randomization, monitor.

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About this handbook. This handbook provides guidance on the legislative, regulatory and good clinical practice (GCP) requirements when conducting clinical trials in Australia using 'unapproved' therapeutic assists trial sponsors, Human Research Ethics Committees (HRECs), investigators and approving authorities (institutions) to understand their roles and responsibilities under the.

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Handbook of SOPs for Good Clinical Practice was prepared as a tool to aid organizations in the development of standard operating procedures (SOPs) for groups involved in the conduct of clinical trials.

It is a revision of an earlier version of the handbook prepared by different authors. Handbook for good clinical research practice book Handbook for Good Clinical Research Practice (GCP) is written with the primary aim of providing user-friendly, ready referenced, comprehensive and practical guide for implementation of internationally accepted principles of GCP in the conduct of clinical research studies on human subjects.

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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 /5(17). This open access book, published under a CC BY license in the Pubmed indexed book series Handbook of Experimental Pharmacology, provides up-to-date information on best practice to improve experimental design and quality of research in non-clinical pharmacology and biomedicine.

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Good clinical practice (GCP) is a set of internationally-recognised ethical and scientific quality requirements that must be followed when designing, conducting, recording and reporting clinical.

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Incorporates new chapters on Managing Conflicts of Curiosity in Human Subjects Research, Clinical Research from the Affected individual's Perspective, The Clinical Researcher and the Media, Information Administration in Clinical Research, Evaluation of a Protocol Worth vary, Clinical.

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Completely revised and updated, the second edition of a classic reference, Handbook of SOPs for Good Clinical Practice provides templates of SOPs ready for Free shipping over $   Randomized controlled trials form the foundation for“evidence-based medicine”, but such research can be relied upononly if it is conducted according to principles and standards collec-tively referred to as “Good Clinical Research Practice” (GCP).This handbook is issued as an adjunct to WHO’s “Guidelines for goodclinical practice.

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