SOP 505 Training Requirements and Creating and Maintaining Training Records v2


download SOP 505 Training Requirements and Creating and Maintaining Training Records v2


This SOP describes training requirements and how training records are created and maintained in order to comply with regulatory requirements of ICH GCP. The SOP determines the minimum training requirements and the process for maintaining training records for NNUH staff UEA staff and students undertaking healthcare research.
In order to demonstrate that training has occurred documentation must be maintained and retained for all staff involved within the research and supporting functions where applicable. The extent and content of this documentation will be determined by each organisation but for NNUH this SOP describes the minimum requirement.

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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.