SOP 206 Adverse Events Identifying – Recording and Reporting adverse events for Non-CTIMP Healthcare Research Studies V3
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SOP 206 Adverse Events Identifying – Recording and Reporting adverse events for Non-CTIMP Healthcare Research Studies V3 Download
Overview
This SOP applies to all research studies sponsored by NNUH and UEA other than CTIMPs / Medical Device Trials . With prior agreement of the sponsor the process may be modified to meet the needs of individual studies.
Categories
ClinicalReference
Date Uploaded
03.08.2023Date Review
31.07.2026File Size
435KbClinical 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.