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Book Cover
Author Kolman, Josef.

Title Good Clinical Practice : Standard Operating Procedures for Clinical Researchers / Josef Kolman, Paul Meng, Graeme Scott
Edition First edition
Published Chichester : John Wiley Sons, 1998
Online access available from:
Wiley Online Books    View Resource Record  


Description 1 online resource (xxx, 210 pages
Series Wiley InterScience electronic collection
Contents Foreword / Tom Gallacher -- Clinical Research -- Phases of a Clinical Trial -- Clinical Trial Design -- History and Development of GCP -- Good Clinical Practice -- What is it? -- Responsibilities of the Investigator -- Standard Operating Procedures -- Organisation of Clinical Trials -- Preparation, Approval and Review of SOPs -- Study Organisation and Planning -- Study Team: Definition of Responsibilities -- Study Files and Filing -- Local Management Requirements -- Review and Validation of the Protocol -- Review of Protocol Amendments -- Case Report Form (CRF) Review -- Investigator's Brochure -- Estimation of Patient Numbers -- Ethics Committee -- Indemnity, Compensation and Insurance -- Laboratory -- Pre-Study Monitoring Visits -- Patient Recruitment and Intention to Enrol -- Obtaining Personal Written Informed Consent -- Obtaining Informed Consent for Patients Unable to Give Personal Consent -- Randomisation and Stratification -- Blinding: Codes and Code Breaking
Case Report Form (CRF) Completion -- Study Drugs -- Monitoring Visits -- Adverse Event and Serious Adverse Event Reporting -- Nursing Procedures -- Clinical Procedures -- Trial Report -- Archiving -- Audits and Inspections -- FDA Regulations Concerning Clinical Trials
Summary There is a growing trend for investigators to adopt a more formal approach to the procedures applied to various stages of clinical trials. Most environments employ some form of standard operating procedures which are designed to be used as 'working tools' within that particular field, e.g. standard operating procedures in hospitals for doctors and nurses. With rigorous standards of good clinical practice being applied to all areas, optimizing the design and use of standard operating procedures is more in demand every day. Topics covered include: * A brief description of the history and development of clinical research and good clinical practice * An explanation of what standard operating procedures are and how they work * A selection of actual standard operating procedures and checklists This well-constructed and timely work, set out in a logical, sequential order provides the necessary material needed to develop a useful set of investigator standard operating procedures
Analysis Pharmacology
Bibliography Includes bibliographical references and index
Notes System requirements: Adobe Acrobat Reader to view PDF file
Subject Clinical trials -- Standards.
Form Electronic book
Author Kolman, Josef.
Meng, Paul.
Scott, Graham.
John Wiley & Sons, Ltd.
ISBN 0470842520 (electronic bk.)
9780470842522 (electronic bk.)
Other Titles Standard operating procedures for clinical researchers