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. The UR-CARE database is now open to conduct retrospective data collection and evaluation. The prospective module of UR-CARE will be set up in the second half of 2018.
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, 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. Dates of the UR-CARE meetings will be added in due course.
- Requested and approved anonymised medical data will be sent to the Coordinator in an Excel form.
Steps of prospective study project approval