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://doi.org/10.3389/fdsfr.2023.1166963

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

digital questionnaires as part of a REDCap project
Event triggering registration

Event triggering registration of a person in the data source

Other

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

Being currently pregnant

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

Other

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

Miscarriage, elective abortion, ectopic pregnancy or stillbirth

Event triggering creation of a record in the data source

pregnant women enroll themselves by completing the digital informed consent through the BELpREG website (see www.belpreg.be)
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?

No

Linkage description, possible linkage

Not yet, but opportunities with linkage to other databases in Belgium are being explored (e.g., with respect to infant development, health administrative data, ..). In the future, data pooling with BELpREG data may also occur with other institutes belonging to the European Network of Teratology Information Services (ENTIS) who also collect medication exposure in pregnancy data and outcomes.
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?

No

Data source last refresh

Common Data Model (CDM) mapping

CDM mapping

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

No