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://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2022.980679/full

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

- Retrospective and prospective
- Via REDCap platform
- Organised into 11 registries collecting data on monogenic autoinflammatory diseases, PFAPA syndrome, undifferentiated systemic autoinflammatory disease, Behçet's disease, Schnitzler's syndrome, VEXAS syndrome, Still's disease, noninfectious uveitis, noninfectious scleritis, spondyloarthritis, and Castleman's disease
- Mostly physician-driven
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

Patient's consent withdrawal

Event triggering creation of a record in the data source

Diagnosis; follow-up visit (at least every 12 months); change of treatment regimen
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, pre-linked

The registries described were not created through linkage with other data sources (not pre-linked).

Linkage description, possible linkage

The registries can potentially be linked to other external data sources on an ad-hoc basis, provided appropriate authorisation and common identifiers are available.
Data management specifications that apply for the data source

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?

No

Data source preservation length

10 years

Approval for publication

Is an approval needed for publishing the results of a study using the data source?

Yes
Common Data Model (CDM) mapping

CDM mapping

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

No