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).

Appendix_THIN

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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?

No

Description of data collection

Data are collected at physicians' level, in EHRs. All patients having at least one contact with a participating physician (GPs and specialists) are included in the database regardless of their pathology and the reasons of consultation. THIN® is anonymised at source, data are considered as non personal data. Each database follows a very strict anonymisation process: several steps from the anonymised data transmission by physicians until the database consolidation, including periodic assessment performed by several qualified third-party companies and monitoring by local authority of data protection (Garante per la Protezione dei Dati Personali’ in Italy).
In all countries, in the contract signed with physicians, Cegedim reminds to the physicians their legal obligations as data controller of their patient data. Patients are informed by the physicians about the collection and anonymisation of the data collected and can object to it. Whenever a patient requests his physician to stop the collection of his information, the physician can mark it in software and no data are therefore transmitted to THIN® database.
Event triggering registration

Event triggering registration of a person in the data source

Disease diagnosis
Other
Practice registration

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

No patient objection for data collection.

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

Loss to follow up
Other
Practice deregistration

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

Patient’s requests to his physician to stop the collection of his information. The physician can mark it in software and no data are therefore transmitted to THIN® database.

Event triggering creation of a record in the data source

Any GP encounter, specialist encounter, pharmacy dispensation, nurse encounter (in some countries), request of analytics, request of referral, ... (the specific situations depend on the country)
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

Monthly

Informed consent for use of data for research

Not 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?

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 status

Completed