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Research & Development at SLaM/IOP

Research & Development at SLaM/IOP. Gill Lambert (Ext 0251) Research Governance/Clinical Trials Facilitator R&D Office, Room W1.08. What is Research Governance?. A framework document that brings together existing guidance into a single document

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Research & Development at SLaM/IOP

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  1. Research & Development at SLaM/IOP Gill Lambert (Ext 0251) Research Governance/Clinical Trials Facilitator R&D Office, Room W1.08

  2. What is Research Governance? • A framework document that brings together existing guidance into a single document • Applies to all research “relating to the responsibilities of the Secretary of State for Health and defines responsibilities with and beyond the NHS”

  3. What does it do? • Improves quality and safeguards the public • Sets standards • Defines mechanisms to deliver standards • Describes monitoring and assessments

  4. Who does it relate to? • Participants in research involving the NHS • Those who undertake research involving the NHS • Those who manage research involving the NHS

  5. How does this relate to you? • R&D Approval for NHS based research • Research Honorary Contracts • Monitoring of Projects • Clinical Trials Legislation

  6. Research Approval Process • Check which NHS organisations you will be using • Contact EACH NHS organisation to check their individual requirements – there is no national system for this as with ethics

  7. SLaM/IOP Approvals • Complete R&D Approval Form • Approvals from Service Directorates and/or Pharmacy • Submit forms and supporting papers to R&D Office • R&D Office signature on IBF Form (funding applications only involving NHS)

  8. Research Honorary Contracts • Requirement of Research Governance Framework • Required with EACH NHS organisation • SLaM contracts issued by IoP Education Support Team or Personnel Department

  9. Monitoring • 10% of projects have to be monitored annually under Research Governance • Interviews conducted on a random selection of projects • Feedback provided

  10. Clinical Trials • Three main things to consider at IOP/SLaM • Clinical Trials (medicinal and non medicinal) require risk assessment • Everybody involved in Medicinal Clinical Trials has to be GCP Trained • Medicinal Clinical Trials to go to the Clinical Trials Unit

  11. Medicinal Clinical Trials and the CTU • Can provide randomisations, statistical advice etc. • Will advise/help get EudraCT No, ISCTRN and CTA • Will advise/provide templates of documentation required

  12. How can I reduce the paperwork? • Single Site Research (NHS Sites) • Pick SLaM as your site • Non-clinical Trials have less paperwork • Come and speak to the R&D Office or check our website at an early stage to check what is required

  13. How can you help us? • Please respond to requests for information promptly • Make sure R&D Approvals are submitted with all supporting papers

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