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?

No

Description of data collection

Annual collection of data from 4 sources (PMSI, CPDPN, PMI, CPAM), anonymization of data in 2 levels, cross-referencing of data between the 4 sources and data management, integration of new data into the existing database.
Event triggering registration

Event triggering registration of a person in the data source

Birth
Other

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

Pregnancy outcome

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

Other

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

If the person objects to be included in the study

Event triggering creation of a record in the data source

Data of the person registered with the health insurance, effective crossing with the CPAM source
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

Cross-referencing of data from the 4 sources based on anonymized identifiers in 2 levels

Linkage description, possible linkage

after anonymization on name, surname and date of birth

Linked data source 1

Pre linked

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

Yes

Data source, other

CPAM (Caisse primaire d'assurance maladie)

Linkage strategy

Deterministic

Linkage variable

patronymic identifier (maiden name + first name + date of birth), marital identifier (married name + first name + date of birth), delivery date

Linkage completeness

Completeness of the linkage can be provided upon request

Linked data source 2

Pre linked

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

Yes

Data source, other

CPDPN (Centre pluridisciplinaire de diagnostic prénatal)

Linkage strategy

Deterministic

Linkage variable

patronymic identifier (maiden name + first name + date of birth), marital identifier (married name + first name + date of birth), delivery date

Linkage completeness

Completeness of the linkage can be provided upon request

Linked data source 3

Pre linked

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

No

Data source, other

Disability registry

Linkage strategy

Deterministic

Linkage variable

patronymic identifier (maiden name + first name + date of birth), marital identifier (married name + first name + date of birth),delivery date

Linkage completeness

Completeness of the linkage can be provided upon request

Linked data source 4

Pre linked

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

Yes

Data source, other

PMI (Protection maternalle infantile)

Linkage strategy

Deterministic

Linkage variable

patronymic identifier (maiden name + first name + date of birth), marital identifier (married name + first name + date of birth), delivery date

Linkage completeness

Completeness of the linkage can be provided upon request

Linked data source 5

Pre linked

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

Yes

Data source, other

PMSI (Programme de médicalisation des systèmes d'information)

Linkage strategy

Deterministic

Linkage variable

patronymic identifier (maiden name + first name + date of birth), marital identifier (married name + first name + date of birth), delivery date

Linkage completeness

Completeness of the linkage can be provided upon request
Data management specifications that apply for the data source

Data source refresh

Yearly

Informed consent for use of data for research

Other

Informed consent, other

There is a committee to evaluate requests for data access

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

Data source ETL specifications (link)

Data source ETL CDM version

2.0

Data source ETL frequency

12,00 months

Data source ETL status

Completed