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).
https://usbale.org/bg/registar-zaharen-diabet/

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

Both the Bulgarian Diabetes Register and the Register of Rare Disease are used for collecting and recording of data.
Data holder: Technical University of Sofia and University Specialised Hospital for Active Treatment of Endicrinilogy (USHATE)
Event triggering registration

Event triggering registration of a person in the data source

Disease diagnosis

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

Death
Loss to follow up

Event triggering creation of a record in the data source

Hospital Discharge, Patient visit, GP encounter, Specislis encounter
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, possible linkage

The data from the Bulgarian National Cancer Registry can be linked to the data from the Bulgarian Diabetes Register and the Register of Rare Endocrine Deseases

Linked data source 1

Pre linked

Is the data source described created by the linkage of other data sources?

No

Data source, other

Bulgarian National Cancer Registry, others possible data sources to be linked to depend on expressed interest

Linkage strategy

Deterministic

Linkage variable

Anonymised Patient Identificator

Linkage completeness

In the process of planning of the major activities
Data management specifications that apply for the data source

Data source refresh

Quarterly

Informed consent for use of data for research

Not Required

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

5.3

Data source ETL status

In progress