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

Using the longitudinal database of 2.3 million patients (Real Patient Database) obtained from anonymized electronic patient records that have been treated within the sanitary areas that are comprised in the database coverage. The sample of physicians is constant and nationally representative.

The electronic medical records are those that are introduced into the software of the doctor with whom he/she consults in the Health Centers, Hospitals and Specialty Centers. The information is transmitted in real time to the servers used to store the clinical information.

This information is anonymized by the source and it is impossible to reverse the process.
Event triggering registration

Event triggering registration of a person in the data source

Disease diagnosis
Practice registration
Start of treatment

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

Death
Emigration
Loss to follow up

Event triggering creation of a record in the data source

Every event that is related to a patient in terms of sanitary acknowledgment creates a new record (patient GP visit, new diagnose, hospitalization, hospital discharge, specialist encounter, dispensation of a medicinal product, recording of a congenital anomaly, laboratory test conduction, etc...).
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

Linkage description, pre-linked

The database uses a patient and doctor ID that is anonimized from the source (before Atrys has access to data). The fact the there are not other variables like center, or geographic area what so ever makes linkage impossible.

Linkage description, possible linkage

The database uses a patient and doctor ID that is anonimized from the source (before Atrys has access to data). The fact the there are not other variables like center, or geographic area what so ever makes linkage impossible.
Data management specifications that apply for the data source

Data source refresh

Monthly

Informed consent for use of data for research

Required for all 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?

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