WHAT IS ENROL?
The European Rare Blood Disorders Platform (ENROL) is the central registry of the European Reference Network on Rare Hematological Diseases (ERN-EuroBloodNet) to group data of patients affected by any of these diseases.
ENROL is an umbrella for both new and already existing registries on rare hematological diseases (RHDs), avoiding fragmentation of data by promoting the interoperability standards for patient registries.
ENROL is built in line with the recommendations of the European Platform on Rare Disease Registration (EU RD Platform)
ENROL closely collaborates with the European Rare disease research Coordination and support Action (ERICA) project, for developing common standards and procedures among the 24 ERNs registries
ENROL is officially endorsed by the European Haematology Association (EHA).
OBJECTIVES
ENROL aims at mapping demographics, diagnosis methods, genetic data, main clinical manifestations and treatments at the EU level by enabling the connection, upgrading and building EU patients registries in line with EU data protection and interoperability standards with the following major objectives:
allowing the identification of patient cohorts to facilitate the development of collaborative projects on basic and clinical research on RHD
pooling of available data on registries and databases across European countries to monitor trends and provide essential epidemiologic information on RHD while enabling the generation of evidence for the optimum allocation of resources and definition of health policies
POLICIES
The ENROL Policy has been adopted, establishing the procedures for participating stakeholders to comply with all legal and ethical considerations that apply to the processing and use of sensitive, personal information and health data, in line with Regulation (EU) 2016/679 General Data Protection Regulation.
ENROL legal frame for secure sharing and re-use of data on patients affected by RHDs enable both entering certified medical data from available sources and re-use of data with third parties, namely medical community, research community, patients and industry.
Legal and ethical documents required in each of the steps of the processing of data have been produced, including an informed consent model, and contracts templates for the collection of data into the registry (“Collaboration agreement”) and its re-sharing with Third parties (“Data sharing agreement”)
GOVERNANCE
The ENROL Consortium, the Steering and the Data Access Committees are the governing bodies of ENROL.
ENROL CONSORTIUM
is the decision making body of ENROL, constituted by the following parties:
Vall d'Hebron University Hospital (HUVH) - Vall d'Hebron University Hospital Foundation - Research Institute (VHIR), Spain
Principal Investigator:
Maria del Mar Mañú Pereira,
Coordinator
The Cyprus Foundation for muscular dystrophy research (CING), Cyprus
Principal Investigator:
Petros Kountouris
Hôpital Erasme - Université Libre de Bruxelles (ERASME / LHUB-ULB), Belgium
Principal Investigator:
Béatrice Gulbis
Assistance Publique - Hopitaux de Paris (AP-HP), France
Principal Investigator:
Pierre Fenaux
STEERING COMMITTEE (SC)
in charge of defining research protocol including research questions and definition of common data elements, as well as drafting the Policy for data access and publishing.
DATA ACCESS COMMITTEE (DAC)
responsible for approving and implementing the Data Access Policy, ensuring the good use of data assets, and ensuring that the requests for access to data held by ENROL align with the purpose of ENROL.
DATA COLLECTION
ENROL is currently actively collaborating in 5 RHDs domains for definition of disease specific registries in line with ENROL:
EU-BLAST
Blastic
plasmacytoid
dendritic cell
neoplasm
HARMONY
Myelodysplastic Syndromes
IMPACT-AML
Acute Myeloid Leukemia
TWIST
Bleeding and coagulation disorders: von Willebrand Disease
Moreover two collaborations with EU funded projects linked to the re-use of patients data for the development of Artificial Intelligence and synthetic data have been established and will continue in the upcoming years: Genomics and Personalized Medicine for all though Artificial Intelligence in Haematological Diseases (GenoMed4All GA101017549) and Synthetic haematological data over federated computing frameworks (Synthema GA101095530) supports the pooling of genomic, clinical data and other "-omics" health through the novel Federated Learning scheme, to advance research in personalised medicine in haematological diseases thanks to advanced Artificial Intelligence models and standardized interoperable sharing of cross-border data.
DATA REQUEST
Third parties interested in accessing anonymized/pseudonymized data held by ENROL will be required to submit an application that details the scientific merit of the project for which the data is needed.
Requests will be reviewed by the Data Access Committee (DAC) composed by health professionals, patients’ representatives and legal and ethical experts, that ensures that the request aligns with the purpose of ENROL.
Once the requests are approved, third parties will be requested to sign an agreement including clauses to legally ban a) any attempt to re-identification, including merging ENROL data to other sources of data and b) attempt to directly contact the patients.
EDUCATION FOR PATIENTS
ENROL Webinar program for patients has been co-designed and organized by ENROL's consortium, ERN-EuroBloodNet ePAGs, and EURORDIS.
IT CONSISTS OF THREE WEBINARS FOCUSED ON DIFFERENT ASPECTS OF ENROL:
How ENROL supports clinical research
IT CONSISTS OF THREE WEBINARS FOCUSED ON DIFFERENT ASPECTS OF ENROL:
ENROL, Networking on European Registries in Rare Hematological Disorders
How ENROL supports clinical research
PROMs and PREMs in ENROL
Do you want to contribute to ENROL Registry?
Any Healthcare provider and existing registry based in a European Member State can provide data to ENROL through:
ACOUNTS/AGGREGATED
LEVEL DATA
PSEUDONYMISED
INDIVIDUAL PATIENT
LEVEL DATA
Pseudonymisation of personal data will be performed by SPIDER, the GPDR compliant tool offered by the
EU-RD Platform in the context of rare disease registries.
If you are interested to participate contact us at coordination@enrolplatform.eu
We will provide you with the Data sharing agreement and the Data dictionary to contribute to the Registry!