SOP 210 v4.0 – Managing Protocol and Regulatory Non-Compliance including Serious Breaches SOP 210 v4.0
The aim of this SOP is to describe the processes to be followed for identifying recording and reporting cases of non-compliance with the trial protocol SOPs GCP and/or regulatory requirements for studies sponsored by the University of East Anglia UEA or the Norfolk and Norwich University Hospital NNUH . This includes discovery of a course of action or event which may constitute either a minor non-compliance a major non-compliance or a serious breach from the approved protocol SOPs GCP and/or regulatory requirements.
Clinical GuidelinesThis 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.