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

By accessing the pathological and histological findings

Access to subject details

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

Yes

Description of data collection

The data is entered manually using an eCRF. The data quality and completeness are guaranteed by the data managers. They check the completeness and quality of the data and consult the physicians if there are any questions or uncertainties. Some participating centres enter the data into the registries themselves manually.
Event triggering registration

Event triggering registration of a person in the data source

Disease diagnosis

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

Death
Loss to follow up

Event triggering creation of a record in the data source

the data is entered continuously; all patients are continually monitored for follow-ups
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

The hospitals in our network are able to provide all the needed medical documents which are important or relevant for a certain indication; we have access to these documents and are able to extract all relevant information

Linkage description, possible linkage

We are able to link our data base to any other registry or data base (lake etc.); we are very flexible regarding linkage to other data sources

Linked data source 1

Pre linked

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

Yes

Data source, other

EHRs from Hospital Information System

Linkage variable

Patient ID

Linkage completeness

Complete

Linked data source 2

Pre linked

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

No

Data source, other

HARMONY

Linkage variable

Patient ID

Linkage completeness

Complete

Linked data source 3

Pre linked

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

No

Data source, other

HONEUR

Linkage variable

Patient ID

Linkage completeness

Complete

Linked data source 4

Pre linked

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

No

Data source, other

Other clinical registries for example

Linkage variable

Patient ID

Linkage completeness

Complete

Linked data source 5

Pre linked

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

Yes

Data source, other

Syngoshare for e.g. Echo findings , BD Cato for Therapy Protocolls

Linkage variable

Patient ID

Linkage completeness

Complete
Data management specifications that apply for the data source

Data source refresh

Quarterly

Informed consent for use of data for research

Required for intervention 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?

No

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

5.4

Data source ETL frequency

3,00 months

Data source ETL status

In progress