R&D SOP 705 – Quality Control and Quality Assurance V3


download R&D SOP 705 – Quality Control and Quality Assurance V3


This SOP describes the Quality Control QC and Quality Assurance QA systems for trials where NNUH or UEA acts as the sponsoring organisation. Delegation of responsibilities must be documented and kept in the TMF. This SOP is intended as an overview of quality systems with more detailed information in specific SOPs.

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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.