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.francecoag.org/SiteWebPublic/html/documentsTele.html

Biospecimen access

Are biospecimens available in the data source (e.g., tissue samples)?

Yes

Biospecimen access conditions

Scientific council agreement + patients consent + committee for the protection of individuals agreement

Access to subject details

Can individual patients/practitioners/practices included in the data source be contacted?

Yes

Description of data collection

Periodic collection of data carried out by physicians on the medical patient file and/or the health record, during medical consultations + periodic collection of self-reported data by patient
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 opposition to FranceCoag follow-up

Event triggering creation of a record in the data source

Patient with all inclusion criteria, and followed-up according to the MHEMO recommended schedule
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

Patient personal data from the FranceCoag database and the CépiDC can be directly matched using the "Responsable de Traitement (RT)" scheme recommended by the French Data Protection Authority (CNIL). Deterministic linkage for CépiDc, in order to determine death causes.

Linkage description, possible linkage

Patient personal data from the FranceCoag database and the SNDS (national health data system) can be directly matched using the "Responsable de Traitement (RT)" scheme recommended by the French Data Protection Authority (CNIL). All linkages for further researches.
Deterministic linkage for SNDS via NIR (social insurance number).
Probabilistic linkage for CRMW.

Linked data source 1

Pre linked

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

Yes

Data source, other

CépiDC

Linkage strategy

Deterministic

Linkage variable

NIR (social insurance number),date of birth,gender

Linkage completeness

100.00%

Linked data source 2

Pre linked

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

No

Data source, other

CRMW

Linkage strategy

Probabilistic

Linkage variable

NIR (social insurance number),date of birth,gender,diagnosis,disease severity

Linkage completeness

80%

Linked data source 3

Pre linked

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

No

Data source, other

SNDS

Linkage strategy

Deterministic

Linkage variable

NIR (social insurance number),date of birth,gender,diagnosis,disease severity

Linkage completeness

100%
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; it depends on the nature of the research (information +/- consent is required)

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?

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?

No