Main description:

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.

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.