SOP 350 – Designing and Developing a Case Report Form V2


download SOP 350 – Designing and Developing a Case Report Form V2


The aim of this SOP is to aid the development and design of CRFs used in clinical trials to collect data generated for a trial subject in accordance with the protocol during the course of their participation in a trial. CRFs also help to ensure compliance with regulatory requirements such as those of the MHRA and as such may be audited or inspected.

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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.