Individual centres can join UR-CARE as independent institutions, this is a matter of sovereignty. However, the individual centres are highly encouraged to join UR-CARE with their national study group, if the possibility exists. This would ease the administrative integration for the individual centres at a national level. In order for a centre to use UR-CARE it will be required to adhere to a legal contract, a Framework of Rules and to use the UR-CARE Patient Consent From (already translated in several European languages). The legal authority of the representative signing on behalf of the centre will also need to be proved.
Study groups that are already established are highly encouraged to join with all their centres to become permanently established retrospective study groups in UR-CARE. Each centre of a study group will first need to individually adhere to the UR-CARE legal documents (as explained in the paragraph above). In addition, a legal agreement ("Permanently Established Retrospective Study Group Agreement") is available to be signed by a legal representative of the study group and by a legal representative of the centre. This agreement will allow the study groups to continue working on retrospective studies in UR-CARE without further approval from the UR-CARE Steering Committee.
Non-permanently established study groups will need to get the approval from the UR-CARE Steering Committee to start a study using the database. The proposal must come from a UR-CARE user, as the Proposals' module to submit study projects is available in the database.
It is not necessary to be an ECCO Member to use UR-CARE for daily clinical care or studies. The application to join UR-CARE can be done by any member or employee of the individual centre. Applications by a member or an employee of the individual centre who is also an ECCO Member might be prioritised by a faster handling of its application.
No synchronisation with an existing database is possible: This is primarily for technical reasons but also because UR-CARE's features have to be fully used in order to gain the maximum benefit from it. A customised PDF or Word report of each patient record can also be printed and filed with the existing hospital records or even shared with the patient.
It is not the aim of UR-CARE to create competition with national registries. UR-CARE has the potential to be the biggest IBD digital database available today and to be a powerful resource for individual health care professionals as well as national IBD Study Groups.
As explained above, there will be the possibility for the national study groups and permanently established retrospective study groups conduct retrospective studies with their data autonomously.
The individual centres remain the owners of the data they enter in UR-CARE (upon patient's consent) and only them will have full access to their patient records (personal and medical data).
A centre is free to use its own data for its projects, to export and share its anonymised medical data with another centre, if it wishes to. A centre will never be able to see the data of another centre in UR-CARE. By default, all users of one centre will have access to all patients’ files of this same centre.
In the framework of a permanently established retrospective study group, the data manager of the study group (DM) will have the possibility to select medical data (personal and sensitive data excluded) from the whole pool of patients of the participating centres which have previously signed the Permanently Established Retrospective Study Group Agreement (see question "How does an institution get started with UR-CARE?"). This data can then be exported by the DM via the Retrospective seed of UR-CARE which anonymises it. This process is valid only for retrospective studies.
If a retrospective study project submitted by a non-permanently established study group is approved by the UR-CARE Steering Committee, B-COM will select the requested variables in UR-CARE, in line with the approved proposal, downloading the previously requested data in an anonymised way and sending it to the DM of the study. Centres will be informed if their anonymised medical data is going to be used in a retrospective study. Authorisations from the centres whose anonymised medical data is going to be used in a retrospective study will not be sought.
IBDIM, on behalf of ECCO, is UR-CARE data processor. IBDIM contracts B-COM to provide clinical research management expertise and to facilitate the regulatory process for individual centres and study groups in accessing the database. IBDIM / B-COM will neither be able to see individual patient health records nor be able to use UR-CARE beyond the purposes of the project.
UR-CARE was developped following ISO/IEC 27001 (Information Security Standard) and ISO/IEC 33000 certified quality technical standards for computer software development. The data is secured in centres located in the EU. Redundant back-ups are performed on a daily basis. Sensitive information is automatically ciphered. The database complies with the data protections and privacy EU Directives (GDPR).
The UR-CARE Contract which will need to be signed by each institute includes an Annex with detailed specifications about IT Security and data protection compliance. This Annex intends to provide a thorough basis for Ethics Committee approval.
UR-CARE is offered by IBDIM to individual centres and study groups free of charge for daily clinical care and the conduct of retrospective studies (using the data collected during daily clinical care). As long as IBDIM is financially capable of maintaining UR-CARE free of charge it will do so. Should this not be the case anymore, the cost for using UR-CARE will be no more than EUR 500/centre/year. If a centre leaves UR-CARE less than two years after joining, it will incur a fee of EUR 500.
The use of the prospective module will incur extra costs which will be covered by the study group (to be estimated on a case-by-case basis depending on the study project).
This is not currently planned.