Clinical Trial Computer System Validation

The purpose of this SOP is to describe the clinical trial computer systems processes used in clinical trials sponsored by King’s Health Partner Organisations for the capture, processing, analysis and reporting of clinical trial data within the partner institutions. The Validation addresses all computerised systems used directly or indirectly to capture, process, analyse and report clinical trial data and to manage clinical development programs before and after regulatory submission. Systems covered range from single programs for specific studies to multi-module data management systems.

Providing documented assurance to the integrity and validity of computer systems will ensure that the partner organisations meet the fundamental requirement of GCP.

In addition this SOP will provide a consistent, risk-based method to determine if a computer system used in a CTIMP adheres to the Medicines for Human Use (Clinical Trials) Regulations.

  SOP: Clinical Trial Computer Systems Validation (686Kb)

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If you require the EDC Provider Specifications Checklist, please contact the Quality Manager.