Sponsorship

Sponsorship

The Sponsor is the organisation taking responsibility for securing arrangements to initiate, manage and finance a study, including provision of insurance and/or indemnity. A Sponsor is required for all types of clinical research - NHS Research Ethics Committees (RECs) and many UK funders now require evidence of sponsorship via a signed application form.

The University of Edinburgh and/or NHS Lothian will take on the role of Sponsor of a research study when it is appropriate to do so. Each institution must actively consent to act as Sponsor.

If you are a University or NHS Lothian employee or student and your research involves humans, their tissue or data, please contact ACCORD for confirmation of sponsorship of your research before the submission for any other approvals. Sponsorship must be in place before e.g. REC favourable opinion, MHRA authorisation, NHS R&D Management Approval are sought.

As Sponsor, ACCORD will provide advice and support throughout your research study with:

● Funding applications
● Protocol development and preparation of other documentation e.g. participant information and consent forms
● Completion and authorisation of the IRAS form
● Amendments
● Regulatory submissions
● Sourcing investigational supplies
● Confirming appropriate insurance
● Legal input and authorised signatories for contracts
● Risk assessment
● QA and monitoring
● Pharmacovigilance

Ongoing sponsorship is subject to the condition that substantial amendments to the study protocol or other study documents are submitted to the Sponsor for approval, prior to submission to REC and the MHRA (if applicable). 


When to Contact Us

Please make contact as early as possible, but as a minimum at the time of your funding application in the case of Clinical Trials of Investigational Medicinal Products (CTIMPs) or at least two weeks before submission of an IRAS REC application for all other types of clinical research.

We aim to complete our initial review for sponsorship within 10 working days. Please be aware it may take longer than this to resolve any issues that may arise, and the speed of your responses will also impact the timeline. 

You are advised that research requiring review by a Medical Physics Expert and/or a Clinical Radiation Expert should be submitted for their review at least 3 weeks before submission.