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://rhekiss.de/

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

Electronic Case Report Forms (eCRF) are provided in a web-based system are filled in by the participating rheumatologist and woman. Via a pseudonymization service, personal data of the patient are de-identified before data is saved in the data storage server.
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

A woman with an inflammatory rheumatic disease can be registered if she wants to conceive or if she is already pregnant (up to gestational week 20).

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

Death
Loss to follow up
Practice deregistration

Event triggering creation of a record in the data source

Data is reported at regular follow-up visits. Before conception: every 6 months with a maximum observation of 2 years. During pregnancy: every trimester. Postpartum: every 6 months with a maximum observation of 2 years.
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
Data management specifications that apply for the data source

Data source refresh

Every 6 months

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