Use of UR-CARE for study projects
The platform offers clinical investigators the opportunity to easily cooperate across projects, using information captured in the database. Investigators will be able to use the database for retrospective as well as prospective data collection and evaluation.
UR-CARE complies with the EU regulations for human studies.
Steps of retrospective study project approval
3 levels of retrospective study project can be conducted in UR-CARE:
- Centre level
- Permanently established study group in UR-CARE
- Non permanently established study group in UR-CARE
Centres and permanently established study groups can conduct retrospective studies with their own data without any further approval from the UR-CARE Steering Committee.
A study group is considered as permanently established in UR-CARE when a legal representative of the group has collected the written consent of each centre of the group, stating that the anonymised medical data of their patients can be used within the group's retrospective projects. Should a study group wish to have a permanently established status in UR-CARE, an agreement form will be made available to them.
For non permanently established study groups, it will be necessary to submit a study project proposal following the steps outlined below:
- Feasibility Query: the Coordinator of the study must submit an online form available in UR-CARE to evaluate the feasibility of their project. It will then be reviewed by the UR-CARE Steering Committee.
- Study Project Proposal: upon approval of the Feasibility Query, the Coordinator will be invited to submit a Study Project Proposal, also available online in the platform. The proposal will be evaluated by the UR-CARE Steering Committee during one of their 3 annual meetings. Submission of the proposal should be at least 2 weeks before the meeting. Dates of the UR-CARE meetings will be added in due course.
- Upon approval of the UR-CARE Steering Committee, the Coordinator will be asked to submit the full list of UR-CARE variables that would be required for the study as well as a copy of the full study protocol.
- Requested and approved anonymised medical data will be sent to the Coordinator in an Excel form via email.
Steps of prospective study project approval