Writing and Managing SOPs for GCP

by Susanne Prokscha

Overview

This book discusses managing SOPs for 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.

Product Details

ISBN-13:	9781040071007
Publisher:	CRC Press
Publication date:	07/29/2015
Sold by:	Barnes & Noble
Format:	eBook
Pages:	224
File size:	500 KB

About the Author

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.

Table of Contents

FOUNDING PRINCIPLES. Introduction to SOPs. Document Hierarchies. When to Have an SOP. What the SOP Should Say. Where to Put the Output. WRITING, REVIEWING, APPROVING, AND POSTING. Who Writes SOPs? Document A Stable Process. Mapping a New Process. The SOP Template. SOP Review and Approval. Posting: Setting Up for Success. MAINTAINING SOPs; MAINTAINING COMPLIANCE. Deviations from Controlled Procedures. Active SOP Maintenance. HELPING STAFF FOLLOW SOPs. Finding SOPs. Training on SOPs? Department-Managed Documents. ADDITIONAL TOPICS. Where to Start. SOPs during Mergers and Acquisitions. Controlled Glossaries. Example SOP Template. Example SOP of SOPs.

Editorial 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

From the Publisher