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)?

Yes

Biospecimen access conditions

Evaluation by Ethical committee, and informed consent must be requested from the patient. Spanish Legislation (article 24 Real Decreto 1716/2011) contemplates several exceptions to obtaining informed consent

Access to subject details

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

Yes
Event triggering registration

Event triggering registration of a person in the data source

Birth
Immigration
Insurance coverage start
Other

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

Any visit to emergency department without any additional requirement

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

Death
Emigration
Other

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

Although person is not active data is preserved since it might be useful in the future for patient care

Event triggering creation of a record in the data source

Each patient that receives care in our hospital
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

Our system is integrated with the Andalusian Health Service IT infrastructure. Diraya Regional EHR has been deployed to provide care for 8 million people through the full network of 50 hospitals and 1,500 Primary care centers distributed throughout the region with 8 million population. We expect that our initiative could be the pioneer for widespread of EMA conducted studies in our whole region since we share the organizational and technical mechanisms for accessing patient data

Linked data source 1

Pre linked

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

Yes

Data source, other

Diraya Regional EHR
Data management specifications that apply for the data source

Data source refresh

Quarterly

Informed consent for use of data for research

Waiver

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 frequency

4,00 months

Data source ETL status

Planned

Data source ETL CDM version

5.4

Data source ETL frequency

4,00 months

Data source ETL status

Completed