Frequently Asked Questions (FAQs)
How does an institution get started with UR-CARE?
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 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 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.
Do I need to be an ECCO Member to use UR-CARE?
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.
Is there a way of synchronising local databases with UR-CARE?
No synchronisation with an existing database will be 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.
The possibility exists for an individual centre or a pemanently established study group to transfer data from an existing database into UR-CARE to avoid any loss of valuable data already collected. In case of national database's import, there will be the option of obtaining support from the IT company.
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.
Will UR-CARE compete with existing databases? How is it envisaged that UR-CARE will work in countries that already have a national registry?
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 to import existing data into UR-CARE and to conduct retrospective studies with their data autonomously.
Who has access to the patient data?
The individual centres remain the owners of the data they enter in UR-CARE 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 study group, the principal investigator (PI) will have the possibility to select medical data (personal and sensitive data excluded) from the participating centres which would have previously signed the Permanently Established Retrospective Study Group Agreement (see question "How does an institution get started with UR-CARE?"). This data could then be exported by the PI 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, IBDIM 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 PI 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 behlaf of ECCO, is UR-CARE data processor. IBDIM will neither be able to see individual patient health records nor be able to use UR-CARE beyond the purposes of the project.
Is the UR-CARE IT technology secure?
The database complies with the data protections and privacy EU Directives.
The security processes of the IT company have ISO 27001 certification (Information Security Standard). UR-CARE was developed following ISO 15504 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 UR-CARE contract which will need to be signed by each institute includes an Annex with very detailed specifications about IT Security and data protection compliance. This Annex intends to provide a thorough basis for Ethics Committee approval.
What is the cost for using UR-CARE?
UR-CARE is offered by IBDIM to individual centres and study groups free of charge. Extar costs may apply if new varibales are requested by national study groups. It would not be possible for individual centres to require additional variables to the ones already existing in UR-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.
Will UR-CARE be available in other languages other than English?
This is not currently planned.