Confirm Sponsor
Trial Planning Phase
The Confirm Sponsor station follows the Trial Registration station and precedes the Feasibility & Investigator Selection station. This process occurs in parallel with Funding Secured, Trial Master File, Trial Registration, and Contract & Agreements. Confirming the Sponsor is a legal requirement which is relevant to all trials. This station is part of the 'trial planning phase' group of stations.
Confirm Sponsor
All clinical trials in the UK require a sponsor. The sponsor will assess the trial’s operational risk before agreeing to take on the role.
For NHS organisations, this review is usually carried out by the organisation’s R&D office. Sponsorship will only be confirmed once any issues identified in the risk assessment have been resolved. Therefore, it is good practice for researchers to engage with potential sponsors early in the trial development process. Once confirmed, a formal sponsorship letter is usually issued and should be retained in the Trial Master File (TMF).
Both the Research Ethics Committee (REC) application and the Medicines and Healthcare products Regulatory Agency Clinical Trial Approval (CTA) must include a sponsor signature (or electronic authorisation), confirming that the organisation accepts responsibility for the trial.
Other stakeholders, such as trial funders and host organisations, will require documented assurance that an organisation has formally accepted the role of sponsor, including the obligations and responsibilities it carries.