SOP 825 Clinical Data Management System VALIDATION v4


download SOP 825 Clinical Data Management System VALIDATION v4


The purpose of this procedure is to give an overview of the clinical Data Management process in terms of the people involved the procedures that are followed and the deliverables that are produced.
Validation of a CDMS through this set of documents:

  1. Demonstrates that a system was developed and implemented and is operated and maintained in a controlled manner throughout its life-time up to and including decommissioning
  2. Results in a high degree of assurance that the system consistently meets its specification and is therefore suitable for its intended purpose.
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Clinical Guidelines
This guideline has been approved by the Trust's Clinical Guidelines Assessment Panel as an aid to the diagnosis and management of relevant patients and clinical circumstances. Not every patient or situation fits neatly into a standard guideline scenario and the guideline must be interpreted and applied in practice in the light of prevailing clinical circumstances, the diagnostic and treatment options available and the professional judgement, knowledge and expertise of relevant clinicians. It is advised that the rationale for any departure from relevant guidance should be documented in the patient's case notes.
The Trust's guidelines are made publicly available as part of the collective endeavour to continuously improve the quality of healthcare through sharing medical experience and knowledge. The Trust accepts no responsibility for any misunderstanding or misapplication of this document.