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).
http://www.EUROmediCAT.eu/currentresearchanddata

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?

No

Description of data collection

Each registry collects data on cases with congenital anomalies (livebirths, fetal deaths from 20 weeks gestational age and terminations of pregnancy for fetal anomaly at any gestation), according to their own local registry processes and governance.
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

Other

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

Case does not have a major congenital anomaly

Event triggering creation of a record in the data source

Not applicable
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

Some registries can link their congenital anomaly data to local prescription or administrative databases in order to obtain more accurate information on medications dispensed during pregnancy. Data have also been previously linked to diabetic cohorts and population cohorts.

Linked data source 1

Pre linked

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

No

Data source, other

20 EUROCAT registries contribute data to the EUROmediCAT central database.

Linkage variable

Available upon request

Linkage completeness

Available upon request
Data management specifications that apply for the data source

Data source refresh

Yearly

Informed consent for use of data for research

Other

Informed consent, other

There is a committee to evaluate requests for data access

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 specifications (link)