Access and validation

Governance details

Documents or webpages that describe the overall governance of the data source and processes and procedures for data capture and management, data quality check and validation results (governing data access or utilisation for research purposes).
Coordination & Steering Committee
Data Access Committee

Biospecimen access

Are biospecimens available in the data source (e.g., tissue samples)?

No

Access to subject details

Can individual patients/practitioners/practices included in the data source be contacted?

Yes

Description of data collection

Data in RADeep is collected through standardized electronic case report forms (eCRFs) within a secure REDCap platform. The process includes patient registration and longitudinal follow-up visits, where clinical, demographic, and laboratory information is systematically recorded by healthcare professionals or trained data entry staff. Quality control procedures such as automated validation rules, branching logic, and periodic data audits ensure accuracy and completeness. The data source integrates information from multiple clinical centers, harmonizing inputs to support comprehensive rare anemia disorder research.
Event triggering registration

Event triggering registration of a person in the data source

Disease diagnosis
Other

Event triggering registration of a person in the data source, other

Signed Informed Consent

Event triggering de-registration of a person in the data source

Death
Loss to follow up
Other

Event triggering de-registration of a person in the data source, other

Patient withdrawal of consent, transplantation

Event triggering creation of a record in the data source

In RADeep, the creation of a new record in the registry is triggered by the initial clinical encounter during which a patient with a suspected or confirmed rare anemia disorder is assessed by a specialist within the network.
The record is created once the patient meets eligibility criteria (alive, not transplanted, and diagnosed with a rare anemia disorder) and informed consent is obtained.
Data source linkage

Linkage

Is the data source described created by the linkage of other data sources (prelinked data source) and/or can the data source be linked to other data source on an ad-hoc basis?

Yes

Linkage description, pre-linked

Yes, RADeep is linked with national registries that provide information about patients included in the RADeep database.
Currently, RADeep integrates data from several national registries related to rare anemia disorders. These pre-linked sources enrich the registry through established national health systems and disease-specific registries.

Linkage description, possible linkage

In addition to existing pre-linked national registries, RADeep can establish ad-hoc linkages with other relevant data sources using Common Data Elements (CDEs) and the SPIDER pseudonymization framework developed by the Joint Research Centre (JRC).

Furthermore, RADeep patients are included in ENROL, the European Rare Blood Disorders Platform, which acts as an umbrella within the ERN-EuroBloodNet network. ENROL consolidates both new and existing registries on rare hematological disorders (RHDs) to avoid data fragmentation by promoting EU RD platform standards for patient registry interoperability.
Data management specifications that apply for the data source

Data source refresh

Monthly

Informed consent for use of data for research

Required for all studies

Possibility of data validation

Can validity of the data in the data source be verified (e.g., access to original medical charts)?

Yes

Data source preservation

Are records preserved in the data source indefinitely?

Yes

Approval for publication

Is an approval needed for publishing the results of a study using the data source?

Yes

Data source last refresh

Common Data Model (CDM) mapping

CDM mapping

Has the data source been converted (ETL-ed) to a common data model?

Yes

CDM Mappings

Data source ETL CDM version

OMOP Common Data Model (CDM) version 5.4

Data source ETL status

In progress