SOP 510 Medical Cover for Clinical Research Trials V2


download SOP 510 Medical Cover for Clinical Research Trials V2


It is a requirement of Good Clinical Practice that:

i. A qualified physician or dentist where appropriate who is an investigator or a sub-investigator for the study should be responsible for all study-related medical or dental decisions

ii. During and following a subject’s participation in a study the investigator/institution should ensure that adequate medical care is provided to a participant for any adverse events including clinically significant laboratory values related to the study. The investigator/institution should inform a participant when medical care is needed for intercurrent illness es of which the investigator becomes aware.

This SOP details the systems that need to be put in place at the start of any clinical research study to meet these requirements.

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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.