Statistical Analysis and Reporting Procedures

This document is a Standard Operating Procedure (SOP) that outlines the procedures for statistical analysis and reporting at the Edinburgh Clinical Trials Unit (ECTU). It applies to all randomized trials that receive statistical support from ECTU. The SOP specifies the responsibilities of ECTU statisticians in performing trial analyses and producing statistical reports. It details the requirements for repeatable analyses and the processes necessary to ensure the accuracy of final reports while minimizing bias. The final analysis must adhere to a pre-specified Statistical Analysis Plan, which should be properly documented. Additionally, the document emphasizes the importance of independent validation of key results before public release. It also discusses the handling of data errors during analysis and the acceptable practices for database management. Relevant documents and references are provided to support the procedures outlined in this SOP.