UR-CARE for Study Projects
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. Prior to conducting research, centres and Study Groups are encouraged to start using UR-CARE according to the conditions defined by the UR-CARE contract. Access to the UR-CARE database is contingent upon execution of the UR-CARE Contract.
The UR-CARE database is open to conduct retrospective as well as prospective study projects. UR-CARE complies with the EU regulations for human studies and with GDPR.
Steps of retrospective study project approval
3 levels of retrospective study project can be conducted in UR-CARE:
- Centre level
- Multi-Centre National Studies in UR-CARE
- International Studies in UR-CARE
Centres can conduct retrospective studies with their own data without any further approval from the UR-CARE Steering Committee.
In a Multi-Centre Research, a Study Group with a legal representative should collect the written consent of each centre of the group, stating that the pseudonymised medical data of their patients will be used within the group's retrospective projects.
For International Studies, anaonymised data will be shared with the Principal Investigator of the Study that is proposed.
It is necessary to submit a study project proposal, via the Proposals' module of UR-CARE, and to follow 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. The feasibility (i.e. availability of the requested data) will be assessed by the ECCO Office.
- 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 4 weeks before the meeting.
- After approval, the requested pseudonymised medical data can be extracted.
For further information, please send your queries to: This email address is being protected from spambots. You need JavaScript enabled to view it.