Clinical Trial Computer System Validation
The validation process for computer systems used across the lifecycle of a clinical trial.
Clinical Trial Computer System Validation
The Standard Operating Procedure (SOP) describes the validation process for computer systems used across the lifecycle of a clinical trial.
Systems may range from single-study applications to multi-module data management platforms, supporting activities before and after regulatory submission.
This SOP applies to all clinical trial data management systems used in trials sponsored, co-sponsored, or managed by King’s Health Partners (KHP) Organisations.
Clinical Trial Computer System Validation Standard Operating Procedure
Clinical Trials Computer System Validation Standard Operating Procedure
Supporting information
The EDC Provider Specifications Checklist available is available on request from the Quality Manager.