SOP 405 Obtaining and maintaining MHRA approval SOP 405


download SOP 405 Obtaining and maintaining MHRA approval SOP 405


The MHRA is the government agency responsible for ensuring that medicines and medical devices are safe in clinical trials of medicinal products. These are substances or combinations of substances or methods/devices which either prevent or treat disease in human beings or are administered to human beings with a view to making a medical diagnosis or to restore correct or modify physiological functions in humans.

Any research that fulfils the definition of a clinical trial as described by the EU Clinical Trials Directive 2001/20/EC Article 2 a  and update EU 536/2019  will require a Clinical Trials Authorisation CTA from the Competent Authority in the Member State in which research is being carried out. It will also require approval from an Ethics committee. A CTA will only be issued by the Competent Authority The MHRA in the UK if it has no objections to the research proposal.

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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.