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  • Last modified date:
    12 June 2009

10 June 2009

MHRA Good Clinical Practice: Risk based inspections

The MHRA has moved to a Risk Based Inspection Process.  The process will use a combination of information provided to the MHRA including a Compliance Report. 
Completion of the Compliance Report by sponsors, contract research organisation (CRO) or hosting sites is not mandatory. However, these organisations should be aware that failure to submit a Completed Report will be assigned to a high risk category.  Currently, Phase 1 units and individual investigators not acting as sponsors of clinical trials are not required to complete the compliance report. GCP Compliance Reports should be submitted to the MHRA by 30 June 2009

8 June 2009

Programme Director - NIHR Research for Patient Benefit (RfPB) Programme

The Director General of Research and Development for the Department of Health, Professor Dame Sally Davies, wishes to contract with an institution/NHS body for the part-time services (about 2 days per week) of a person to be appointed Programme Director of the National Institute for Health Research (NIHR) Research for Patient Benefit Programme. The Programme has an annual expenditure of up to £25 million per year. The successful applicant could be from either an NHS management, clinical or academic research background.

14 April

Publication of Guidance on funding excess treatment costs related to non-commercial research studies and applying for a subvention

 DH has published new guidance for funding excess treatment costs and subventions to clarify the directions set out in HSG(97)32. The guidance takes into account changes made as a result of the research strategy Best Research for Best Health and the introduction of Payment by Results, and relates to non-commercial research studies eligible for entry onto the National Institute for Health Research (NIHR) Clinical Research Network Portfolio database. The principles outlined in HSG(97)32 remain unchanged.

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