SOP 865 Study Specific Document Management


download SOP 865 Study Specific Document Management

The purpose of this Standard Operating Procedure SOP is to identify the range of study-specific controlled documents approved for use in the conduct of health care research and to describe the standard procedures to be followed for the management of controlled documents related to clinical research sponsored by the NNUH or UEA.
This SOP does not apply to commercially sponsored research or research sponsored by an external non-commercial organisation. Where research teams are a participating Site it is the responsibility of the research teams and the study Sponsor to ensure teams are working from the most current version of the study documentation.
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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.