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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.
List 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.
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.
Summary
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.
