A sponsor is the legal entity that takes responsibility for the trial and for ensuring arrangements are in place to initiate and manage the study, including ensuring appropriate indemnity arrangements are in place for the study subjects.
The funder of the study is not necessarily the sponsor. Trinity College Dublin with the support of the Clinical Research Facility in SJH will take on the role of the Sponsor of a research Study when it is appropriate to do so.
The Clinical Research Facility and Trinity can provide advice and support throughout your research study with:
- Funding applications
- Protocol Development and Preparation of other trial related documents
- Ethics applications
- Regulatory Submissions
- Confirming appropriate insurance
- Legal input for contracts
- Risk assessment
- Quality assurance and auditing
- TMF management
- Data management
- Vendor management
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 ethics, or the regulatory authority (if applicable).
How to apply for sponsorship
The University must actively consent in writing if it is to act as sponsor.
If you would like the University to sponsor your study, please contact us as early as possible and at a minimum at the time of your funding application for the study.
Who to contact:
Ruben Eavan Keane
Head of Clinical Sponsorship Oversight (HCSO), Trinity College Dublin
Sponsor Quality and Regulatory Affairs, Trinity College Dublin
University Sponsorship policy:
Please see the Trinity College Dublin: Policy and Procedure for University Sponsorship of Regulated Clinical Trials version 4.0 11th Nov 2019 for more information.