Overview
Writing and Managing SOPs for GCP is the first book to discuss managing Standard Operating Procedures (SOPs) for Good Clinical Practice (GCP) from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book provides a user’s point of view to keep topics focused on the practical aspects of SOPs and SOP management. The idea of specifically calling out approaches to SOP creation and maintenance in an effort to make it easier for users to stay in compliance is a theme found throughout all book chapters. Examples in each chapter provide accurate reflections of real-world experiences to illustrate the discussion. The book also includes an example ""SOP of SOPs"" along with an associated SOP template.
Full Product Details
Author: Susanne Prokscha
Publisher: Taylor & Francis Inc
Imprint: CRC Press Inc
Dimensions:
Width: 15.20cm
, Height: 1.80cm
, Length: 22.90cm
Weight: 0.430kg
ISBN: 9781482239355
ISBN 10: 1482239353
Pages: 224
Publication Date: 29 July 2015
Audience:
College/higher education
,
Professional and scholarly
,
Postgraduate, Research & Scholarly
,
Professional & Vocational
Format: Hardback
Publisher's Status: Active
Availability: In Print
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Reviews
Writing and Managing SOPs for GCP miraculously transforms the boring floss of standard operating procedures into the interesting gold of...SOPs. A reader of this book will find it is hard to imagine managing SOPs without having read the book. -Norman M. Goldfarb, in Journal of Clinical Research Best Practices, Vol. 12, No. 2, February 2016
Writing and Managing SOPs for GCP miraculously transforms the boring floss of standard operating procedures into the interesting gold of...SOPs. A reader of this book will find it is hard to imagine managing SOPs without having read the book. -Norman M. Goldfarb, in Journal of Clinical Research Best Practices, Vol. 12, No. 2, February 2016
Author Information
Susanne Prokscha is a director in clinical data management for process and training at Onyx Pharmaceuticals in San Francisco, California. She has been involved in clinical data management (CDM) processes and technologies since the mid-1980s. Ms. Prokscha has worked both as a consultant and directly for large and small companies, gaining experience with a wide range of studies and a variety of clinical data management systems. Her interest in advancing the field of CDM and helping emerging CDM groups led her to write Practical Guide to Clinical Data Management. She currently focuses on process development, SOP writing, document management, and training for CDM and Biometrics groups.
