SOP 205 Adverse Events v3


download SOP 205 Adverse Events v3


This SOP is for all staff members at the NNUH and the UEA who are involved in healthcare research and has been produced in accordance with the Medicines for Human Use Clinical Trials Regulations  to ensure that systems are in place for pharmacovigilance and the recording managing and reporting of adverse events in Clinical Trials of Investigational Medicinal Products CTIMPs .

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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.