SOP 805 – Clinical Data Management System – CDMS SET-UP v4


download SOP 805 – Clinical Data Management System – CDMS SET-UP v4


The purpose of this procedure is to describe the setup and agreement of a data management strategy for the study. The data management strategy covers the management and manipulation of the study data and the development and/or validation of any tools used to collect store and process the data. The main deliverable from this procedure is a Data Management Plan DMP which outlines the details of the Clinical Data Management System CDMS to be set up lists relevant documents and references relevant procedures.

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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.