Writing and Managing SOPs for GCP

Writing and Managing SOPs for GCP

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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 usera€™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 qSOP of SOPsq along with an associated SOP template.Templates: ese provide a structure and (optional) default content for a document that is then customized with information specic to a study or activity in question; templates must be associated with an SOP or work instruction. Manuals: eseanbsp;...

Title:Writing and Managing SOPs for GCP
Author: Susanne Prokscha
Publisher:CRC Press - 2015-07-02

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