SOP 330 – Monitoring Clinical Trials

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Overview

The aim of this SOP is to describe the process for Monitoring of Clinical Trials sponsored by the Norfolk and Norwich University Hospitals NHS Foundation Trust. This SOP outlines the responsibilities of the Sponsor and Investigators with regard to monitoring clinical trials sponsored by the NNUH and describes the processes to be undertaken by the monitor or delegated staff to prepare conduct report and follow-up monitoring visits from study set-up until close down.

Categories
Clinical
Reference
Date Uploaded
15.12.2016
Date Review
30.11.2018
File Size
821Kb


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.