SOP 720 v1.0 – Risk Assessment of Trials Sponsored by the NNUH and UEA

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download SOP 720 v1.0 – Risk Assessment of Trials Sponsored by the NNUH and UEA
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Overview

Sponsors are required to provide oversight of studies to ensure adequate protection of the participants sponsor and data integrity; however conducting research carries inherent risks. The purpose of a risk assessment is to identify potential hazards and assess the likelihood of those hazards occurring and resulting in harm. Dependent on the risks of a study alternative/proportionate monitoring may be considered when developing monitoring strategies.

Categories
Clinical
Reference
Date Uploaded
15.12.2016
Date Review
30.11.2018
File Size
738Kb


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.