SOP 305 – Creating and maintiaining TMF & ISF V1.6


download SOP 305 – Creating and maintiaining TMF & ISF V1.6


This SOP is intended as a practical guide to setting up a Trial Master File / Investigator Site File and the essential documents it should contain.  

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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.