SOP 800 Non Study Specific Document Management


download SOP 800 Non Study Specific Document Management

This SOP describes the range of controlled documents that are approved for use in the conduct of all health care research and how such documents may be managed to ensure they are fit for purpose and are accessible when needed.
The focus of this SOP will be on the management and control of non-study specific documents the majority of which will be written by the NNUH R&D department the UEA RIN office and other central departments. Such documents include but are not limited to policies standard operating procedures forms QC and QA data contracts agreements and risk assessments.
For the management and control of study specific documents written mainly by the CI / PI such as protocols participant information sheets PIS informed consent forms ICF GP letters advertisements and data collection media including case report forms refer to SOP 865 Study Specific Research Documentation Management.
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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.