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.bndmr.fr/exploiter/donnees-bndmr/charte-bndmr/
https://www.bndmr.fr/le-projet/la-gouvernance/
https://www.bndmr.fr/wp-content/uploads/2019/10/COSCI_BNDMR_REGLEMENT-INTERIEUR.pdf

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

Data collected by health provider through EHR or BaMaRa application directly. Data are then pseudonymized into the BNDMR.
Event triggering registration

Event triggering registration of a person in the data source

Disease diagnosis
Practice registration

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

Other

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

objection to the re-use of their data for research

Event triggering creation of a record in the data source

First visit in the rare disease expert centre
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

Linked data source 1

Pre linked

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

No

Data source, other

French Health Data System

Linkage strategy

Deterministic

Linkage variable

National identifier for deterministic linkage. Date of birth, sex, health care providers and outpatient and inpatient visit dates.

Linked data source 2

Pre linked

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

Yes

Data source, other

French National Registry of deceased persons

Linkage strategy

Combination

Linkage variable

Name, Surname, Birthdate, Sex

Linkage completeness

85.00%
Data management specifications that apply for the data source

Data source refresh

Monthly

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?

No

Data source preservation length

20 years

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

CDM name (other)

SDM-MR

Data source ETL specifications (link)