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.
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