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).

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

ARCA is a Real World Data collection, coming from EHR systems used in healthcare processes. Acknowledge authorship, contributions and data provenance. To be strictly evaluated on single-case basis.
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

Hospital encounter started

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

Other

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

End of the Hospital encounter

Event triggering creation of a record in the data source

Clinical activities recorded in EHR according to its recording time
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

Data are currently pseudonymized with a high entropy pseudo-id. We have the source EHR data with full identification of the patients, under the right legal constraints applied we could expose other identificators to allow cross-referencing with other DB (this requires patients' consent).
Data management specifications that apply for the data source

Data source refresh

Yearly

Informed consent for use of data for research

Required for intervention 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?

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 CDM version

1.0

Data source ETL frequency

12,00 months

Data source ETL status

Completed

CDM name (other)

HL7 FHIR

Data source ETL CDM version

R4

Data source ETL frequency

1,00 month

Data source ETL status

Completed

Data source ETL specifications (link)