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Clinical data management (CDM) has gone from predominantly relying on the collection of data on paper forms to using electronic data capture (EDC). Today, the assumption is that a trial will be conducted using EDC and that extenuating circumstances might lead to it being conducted using paper. This third edition emphasizes the EDC process. The chapters in the text are organized to represent the main elements of CDM: study startup, study conduc...

This book discusses managing SOPs for GCP from conception to retirement. It will recommend approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book will provide a user s point of view to keep topics focused on the practical aspects of SOPs and SOP management.