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).

SACHA Methodology and Governance

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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

Electronic eCRF for individual patients
Event triggering registration

Event triggering registration of a person in the data source

Start of treatment

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

End of treatment

Event triggering creation of a record in the data source

Voluntary enrollmet of patient by physician after prescription of an anticancer off label or compassionate use medicine
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
Data management specifications that apply for the data source

Data source refresh

Quarterly

Informed consent for use of data for research

Other

Informed consent, other

According to the French Law (Loi Jardé), only collection of non-opossition is needed

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?

No