Clinical Trial Sponsorship at Trinity
What is Clinical Research?
Clinical Research is the study of humans (patients or volunteers) their bio samples/ and or their data. Clinical research may be observational, or interventional.
Some interventional trials may come under the Clinical trials Regulation or the Medical Device Regulation/ In vitro Medical Device Regulation.
All interventional clinical research carried out at by Trinity researchers must be notified to TCD Sponsor: clinicaltrialsponsorship@tcd.ie
All multinational clinical research (including observational studies) must be notified to TCD Sponsor: clinicaltrialsponsorship@tcd.ie
What is a Trial Sponsor?
A Trial sponsor is the legal entity that takes responsibility for the legal, financial and insurance requirements of a Clinical Trial. Trinity College Dublin, with the support of the Clinical Research Facility in St James's Hospital, may take on the role of the Sponsor of a research study/ trial when the University judges it appropriate to do so.
What is the role of TCD Sponsor staff?
TCD sponsor staff are responsible for ensuring that Clinical Research carried by TCD researchers/ clinical investigators:
- Complies with all applicable legislation. This may include Clinical Trial Regulation, Medical Device Regulations, ICH Good Clinical Practice E6 (GCP) and the Health Research Regulations.
- Is carried out to the high-quality standards expected at Trinity.
TCD sponsor staff also:
- Review the study and decide/ recommend to Dean of Research if Trinity will sponsor the clinical research.
- Classify the trial / study and advise investigator if the trial requires Health Products Regulatory Authority (HPRA) and National Research Ethics Committee (NREC) application.
- Provide guidance to researchers (as resources allow) in writing trial protocols, participant information leaflets and informed consent forms. This should be done prior to submission to the relevant Research Ethics Committee and Health Products Regulatory Authority (HPRA).
- Facilitate and oversee clinical research carried out within the University.
- Liaise with Trinity insurers to ensure that Trinity can cover the protocol insurance adequately.
- Work with University researchers to enable conduct of clinical research to the highest quality standards.
- Signpost training in Good Clinical practice for investigators and care staff
- Ensure monitoring for clinical research sponsored/hosted by the University.
- Coordinate safety reporting/ Pharmacovigilance/ Device Vigilance and ensure compliance with relevant legislation and guidance.
Getting Sponsorship for a Trial
Please contact Sponsor staff as early as possible when planning a clinical research project: clinicaltrialsponsorship@tcd.ie
You should request sponsorship in principle when applying for your research funding.
- Click here to complete the Sponsorship Request Form
- Access a pdf copy of the Sponsorship Request Form here
- Policy on Sponsorship of Clinical Trials
Standard Statements for use in Patient Information Leaflets (PIL) of Trinity Sponsored Clinical Trials/Studies
To assist researchers with the preparation of study documents, and to ensure that all necessary information is included, the Sponsor Team - in consultation with the Data Protection Office and the Research Contracts Office- have developed some standard statements which you should include in the Patient Information Leaflet (PIL) for Trinity Sponsored Clinical trials/studies.
Standard wording re insurance for Trinity Sponsored Clinical Trials of Investigative Medicinal Products
| What if something goes wrong? |
|---|
It is rare for a medicine to seriously harm anyone in a trial. However, the trial may be stopped for various reasons. They can be due to ethical worries, any reactions to the medicine or any safety concerns in relation to the hospital site at which the trial is being carried out. Insurance cover is in place by the Sponsor (Trinity College Dublin), the hospital site and the makers of the medicine in the unlikely event that you are injured or harmed in any way as a result of taking part in the trial. In such cases, you will be provided with follow-up care. In the unlikely event that you become unwell during the trial, the research being carried out may be abandoned or delayed, depending on the situation. |
Standard wording re Personal Data for Trinity Sponsored Clinical Trials of Investigative Medicinal Products
How is my personal data protected? |
|---|
Any personal data required for this trial will be coded to protect your privacy. The study team replace your name with a unique code. This code is used on all information or samples used in the trial. A separate key which links your name to your unique code is saved securely at the site. |
Who will access my personal data? |
|---|
The study team, and representatives of the Sponsor (Trinity College Dublin) will need access to your personal data to carry out and monitor the trial. Regulatory authorities such as the Health Products Regulatory Authority (HPRA) in Ireland, the Data Protection Commission (DPC), auditors and representatives from the National Office for Research Ethics Committees (NREC), may also require direct access to your personal data (including your medical records) to verify your participation in the study, ensure your safety throughout, and to monitor or audit the trial. Access will be strictly limited to the authorized personnel from any of the organisations listed above. |
Sponsor Team
*** Queries should be sent to clinicaltrialsponsorship@tcd.ie ***