Establishing and Maintaining a Statistics Master File

This Standard Operating Procedure (SOP) provides detailed instructions on establishing and maintaining a Statistics Master File (SMF) for studies supported by the Edinburgh Clinical Trials Unit (ECTU). The document outlines the responsibilities of the Trial Statistician or designee in implementing the SOP and describes the procedures for creating a paper-based SMF for each Clinical Trial of Investigational Medicinal Products (CTIMP) or regulated device study requiring statistical input. It specifies the need for an electronic backup of the SMF and the secure storage of the paper-based file. The SOP includes guidelines for organizing the SMF into nine sections, which encompass essential documents such as statistical review checklists, sample size calculations, and final report authorizations. Additionally, it addresses the ongoing maintenance and review of the SMF to ensure completeness before archiving. The document also references relevant templates and documents necessary for compliance with the established procedures.