SOP 400 v1.4 – Joint Arrangements For Authorisation Of Research Sponsorship SOP 400 v1.4
The Research Governance Framework for Health and Social Care First Edition was published by the Department of Health in 2001 and has subsequently been superseded by the UK Policy Framework for Health and Social Care Research. Research which falls within the scope of the UK Policy Framework for Health and Social Care Research requires a research Sponsor. A Sponsor in this context is not the same as the funding body although in some cases the Sponsor and the funding body are the same organisation . The Sponsor is the individual or organization that takes on responsibility for confirming there are proper arrangements to initiate manage monitor and finance a study section 9.10 of the UK Policy Framework for Health and Social Care Research . For research that falls within the scope of the UK Policy Framework for Health and Social Care Research it is for the Sponsor to be satisfied that clear agreements are reached documented and carried out; providing for proper initiation management monitoring and financing. For CTIMPs the Medicines for Human Use Clinical Trials Regulations 2004 define legal responsibilities that the Sponsor must arrange and carry out.
Clinical GuidelinesThis 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.