Clinical trial support

Clinical Research Facilitators are your first point of contact for setting up a clinical trial. They guide you from the earliest stages, helping shape your research question, advising on design, costings, documentation and approvals, ensuring your trial is feasible and compliant.

They also connect you with specialist teams, share tools and guidance and help to establish the right oversight for your trial. Once your trial is live, Facilitators hand over to Monitoring colleagues, ensuring a smooth transition and continued support throughout the trial.

Steps for planning and setting up a successful clinical trial

1. Engage early with ACCORD

Get in touch with us as early as possible - ideally while you’re still developing your research question. A Clinical Research Facilitator will be assigned as your Sponsor Representative to guide you through the planning and set-up process. In particular, they will:

  • Clarify which approvals are required and advise on the necessary documentation and expected timelines for applications.
  • Advise on trial design and management support, including data management and statistical planning, and refer you to a Clinical Trials Unit if needed.
  • Provide input for accurate costings to include in your research funding applications.
  • Share templates and guidance to help you develop a feasible, participant-friendly protocol and supporting study documents.
  • Liaise with Quality Assurance, Monitoring, and Pharmacovigilance teams to establish appropriate oversight tailored to your trial’s needs.
  • Advise on contractual requirements, working in partnership with the Edinburgh Research Office and NHS Lothian Contracts teams to progress agreements.
  • Initiate a Combined Risk Assessment in collaboration with the Quality Assurance team.
  • Hand over to the Monitoring team once your trial goes live, ensuring continued support throughout its delivery.

2. Budget realistically

Engage early with the Edinburgh Research Office - they will assign a dedicated Research Funding Specialist who will work in partnership with ACCORD to help you develop a robust budget and secure appropriate funding for your trial.


3. Confirm sponsorship early

Every clinical trial must have a Sponsor - and the earlier this is confirmed, the better.

Determining sponsorship early helps avoid unnecessary delays and ensures all regulatory and governance requirements are met from the outset. In most cases, sponsorship will be provided by the University of Edinburgh and/or NHS Lothian, but in some situations (for example, with commercial funders), it may be more appropriate for another organisation to take on this role.

If you're unsure who the Sponsor should be, we’re here to help - get in touch as early as possible so we can advise and begin the necessary discussions.


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