Standard Operating Procedures (SOPS) for all controlled aspects of the clinical trial are an essential part of clinical trial quality management. They require a robust system to manage and modify them and training should be put in place to ensure all personnel are operating according to standard approved practice as set out in the protocol. The list of activities requiring SOPS and their indexing should be detailed in the Trial Management System (see process).
2. SOP: Template for Document Control and SOP Writing: http://www.admin.ox.ac.uk/rso/clinical/downloads.shtml#SOPwriting
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