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What's New Archive
30 November 2005
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Medicines and Healthcare Products Regulatory Authority (MHRA) Inspection
The R&D Department has been notified that the MHRA will be inspecting the Leeds Teaching Hospitals NHS Trust sometime early in the New Year. As part of the EU Clinical Trials Directive, the MHRA has a statutory requirement to carry out GCP inspections of organisations performing and/or sponsoring clinical trials of investigational medicinal products (CTIMPs).
We will be contacting specific researchers to provide adivce and support for the preparation of the actual inspection itself as soon as we receive further details of the inspection from the MHRA.
In the meantime, further information about the inspections can be found on the MHRA website.
30 November 2005
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Implementation plan for REC ad hoc advisory group's recommendations
The draft plan for implementing the recommendations of the report of the ad hoc advisory group on the operation of NHS research ethics committees and has been completed and agreed by the NPSA's board and Change Advisory Group. The implementation plan will be put to public consultation once it has gained ministerial approval.
COREC will be discussing the key issues at a range of events for RECs and others. See the COREC website .
30 November 2005
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New COREC guidance on patient information sheets
COREC has revised its guidance on information sheets and consent forms for research participants. The revision addresses feedback from research participants, researchers and sponsors, as well as taking into account recent guidance and changes in the legal and regulatory framework which have had implications for the principle of informed consent. See the COREC website .
14 September 2005
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The National R&D Forum
The NHS R&D Forum have collated the most common questions relating to use of the R&D form and produced guidance for researchers completing the form. A copy of these queries is available on the R&D Forum website or click on the link below
15 August 2005
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New NHS Research Strategy Published for Consultation
The Department of Health has published its new national strategy for health research which is open for consultation (to 21st October 2005). Following discussion at the last R&D Forum, it was agreed that the Trust would make a response to this on the basis that Sally Davies visited us recently and we are one of the most research active Trusts in the UK. Individuals can of course make their own individual responses. Please would you send any comments you have on this to Jonathan Gower. This will be a major topic for discussion at the next R&D Forum when the Trust's response will be finalized in time for submission before the deadline.
The strategy can be viewed on the Department of Health website. http://www.dh.gov.uk/assetRoot/04/11/69/35/04116935.pdf
10 June 2005
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The Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees
The Ad Hoc Group's report was announced on 6th June 2005. Its recommendations are designed to streamline the procedures for ethical review and ensure that committees work more intensively and efficiently, helped by stronger administrative support. The report has now been passed to the NPSA to take forward consultation work on how best to implement these recommendations.
The full report is available from the Department of Health website.
15 March 2005
Welcome to the R&D Handbook!
We hope that you will find this a useful and informative siteGiven that R&D and Research Governance is a changing and dynamic world, this website is designed to be anevolving resource. Please keep checking ‘What's New' for details of updates to the site.
Sections that will be developed and added to this site in the coming months include:
- LTHT R&D Guidance on Retention of Research Records
- Updated Research Sponsor Guidance
New developments in R&D Approvals process include:
Full Costing of R&D ProjectsIntroduction of the National R&D Approval FormUpdated Policy on the Management of Commercial Research
25 January 2005
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New National R&D Strategy Launched
The new NHS Research Strategy ‘ Best Research for Best Health '
was formally launched on 25 January 2006.
The strategy outlines the direction that NHS research and development (R&D) will take over the next five years to ensure a vibrant, world-class environment for conducting and using NHS health research. The strategy is accompanied by a series of outline implementation plans and represents a radical change to current research and development (R&D) arrangements.
Summary of Strategy
- Investment in key research technology platforms
- Research or Patient Benefit, and Invention for Innovation schemes