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://biologika-register.de/en/

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

Longitudinal observational cohort study; once enrolled, patients are observed for at least 5 and up to 10 years. Inclusion is with start of a biologic DMARD or a tsDMARD or a csDMARD after at least one csDMARD failure. Diagnose of rheumatoid arthritis has to be secured by the rheumatologists according to standard criteria.
Event triggering registration

Event triggering registration of a person in the data source

Start of treatment

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 declines further participation in the observation.

Event triggering creation of a record in the data source

After inclusion, new data is created on a regular base (without trigger). After 3 and 6 months and thereafter every 6 months, data is obtained from physicians and patients (e.g. regarding disease activity, treatment and treatment changes, reasons for that, adverse events, PROs). If no data is coming in at the intended time point of follow-up, reminders are sent to the physician.
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?

Yes

CDM Mappings

Data source ETL CDM version

5.3.1

Data source ETL status

In progress

Data source ETL specifications (link)