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

The Biospecimens are stored in the Medical center lab, access required an IRB approval.

Access to subject details

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

Yes

Description of data collection

All data is collecting during the patient treatment at the hospital, one can divide the data into 3 main types: Emergency room, admission and outpatient clinics.
Event triggering registration

Event triggering registration of a person in the data source

Start of treatment

Event triggering creation of a record in the data source

The trigger for creating a data is record a patient in the Hospital EHR this can be due to inpatient admission, emergency admission of outpatient visit.
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

We perform the same anonymization and unify ID process for the images and it's related metadata from the NON EHR systems, completing this process, the linkage to the OMOP data is by the same person ID

Linked data source 1

Pre linked

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

Yes

Data source, other

The OMOP data gathering information form the main EHR system, for a study require additional information from NON EHR systems, we combines all information need in the same study data-set.
At the hospital three are additional systems like: PACS that contain many different type of imaging, intracoronary pressure measurement system, In vitro fertilization (IVF) system and more.

Linkage variable

The linkage variable between the OMOP data and other NON OMOP data is the network unique person_id.

Linkage completeness

The linkage result in a full patient information attached to each NON OMOP information, like images or intravascular pressure test.
Data management specifications that apply for the data source

Data source refresh

Quarterly

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?

Yes

CDM Mappings

Data source ETL CDM version

5.3

Data source ETL frequency

3,00 months

Data source ETL status

Completed