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Clinical Research Governance and QA Office
The Clinical Research Governance & QA Office supports researchers who are performing research involving humans, their tissues or data to help them meet regulatory and research governance requirements. Our aim is to ensure the University of Edinburgh as a whole fulfils the legal, ethical and scientific obligations to the healthcare research process.
The office sits within the Academic Clinical and Central Office for Research & Development - ACCORD, which is a partnership between the University of Edinburgh and NHS Lothian and is the first port of call for researchers in Edinburgh planning a clinical research study.
What can ACCORD do?
- Act as Sponsor for your research study
- Provide advice and facilitation at any stage of your research study:
- Grant applications/funding
- Protocol preparation
- Approvals (ethics, R&D, MHRA etc)
- Study set-up
- Ongoing help through recruitment and follow-up
- Monitoring
- Study closedown
- Provide monitoring, pharmacovigilance and audit services
- Provide expert legal input and authorised University of Edinburgh and NHS Lothian signatories for contracts
- Ensure appropriate insurance and liability provisions are in place
- Discuss any governance and regulatory issues with you, providing training and guidance
- Put you in touch with other professionals, groups and units for support and advice
When to get in touch?
All healthcare research projects involving humans, their tissue and/or data must have a named Sponsor. Research Ethics Committees, regulatory authorities and many UK funders now require evidence of Sponsorship.
If you are a University of Edinburgh or NHS Lothian employee or student and your research involves humans, their tissue and/or data, you must contact ACCORD for confirmation of Sponsorship of your research before applying for funding and research approvals.
The earlier you contact ACCORD with your research planning, the more we can do to help.
This article was published on Oct 18, 2010