Frequently Asked Questions (FAQs)
Is it be possible to have an interface between UR-CARE and another database or Electronic Health Records (EHRs)?
It is understood that institutes may at first be reluctant to import their database to an external one. Synchronising an already existing database is not an option. The purpose of UR-CARE is to provide the centres with a full solution covering daily clinical care and research projects and synchronisation would not fulfil this purpose.
A customised PDF or Word report can be printed of each patient record and could be 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 HCPs as well as national IBD study groups. If a country wishes to import its data into UR-CARE after testing the tool, ECCO will support the data transfer.
National IBD study groups will remain autonomous in conducting retrospective studies with their data.
Who has access to the data from individual centres?
Only the centres have full access to their full patient records (personal and medical data). A centre is free to use its own data for 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 the centre available in UR-CARE.
Centres will be informed if their anonymised medical data is going to be used in a study.
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 to individual centres and study groups free of charge. 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 of 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.
How does an individual centre join UR-CARE?
Individual institutes can join UR-CARE independent of their study group, this is a question of sovereignty. However, it is highly encouraged that individual institutes join UR-CARE with their study group, if the possibility exists. This would ease the administrative integration for the individual centres at the national level.
How does a study group join UR-CARE?
Study groups that are already established are highly encouraged to join UR-CARE with all of their centres. A legal agreement (Permanently Established Retrospective Study Group Agreement) is available to be signed by a legal representative of the study group and its centres. This agreement will allow the study groups to continue working on retrospective studies in UR-CARE. For prospective studies approval from the UR-CARE Steering Committee will need to be sought.
For non-established study groups, approval will be needed from the UR-CARE Steering Committee to conduct both retro- and prospective studies.