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).
https://iknl.nl/en/about-iknl

Biospecimen access

Are biospecimens available in the data source (e.g., tissue samples)?

Yes

Biospecimen access conditions

Via PI

Access to subject details

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

Yes

Description of data collection

Patients with advanced SCC are identified in the nationwide pathology database (PALGA) using a pathology algorithm developed by our department (https://pubmed.ncbi.nlm.nih.gov/35926654/). Once identified, these patients are sent to the NCR for registration. The NCR registrars will record patient, tumor, and treatment details as outlined in the manual and conduct follow-up every 6 months.
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 NCR registrars will conduct follow-up every 6 months after histopathologically confirmed advanced SCC diagnosis
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, possible linkage

A request for linkage between the data sources will be sent by the researcher to both Scientic and Privacy committees of the respective data sources. To ensure that no patient information is disclosed to the researcher, or transferred between e.g., NCR-PALGA, a Trusted Third Party (ZorgTTP) is required to perform several pseudonymization steps to encrypt the data. The researcher only receives fictious administration numbers in the end.

Linked data source 1

Pre linked

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

No

Data source, other

This datasource contains nationwide linked data on cancer incidence (IKNL), pathology (Palga), hospital discharge diagnosis (LBZ), health insurance and cancer mortality (CBS), Netherlands Organ Transplant Registry (NOTR)

Linkage strategy

Other

Linkage variable

There is no single linkage key available. The linkage variable depends per linked data source.

Linkage completeness

The linkages are all on a nationwide level, so therefore as good as complete (100% completeness).
Data management specifications that apply for the data source

Data source refresh

Quarterly

Informed consent for use of data for research

Other

Informed consent, other

There is a scientific- and privacy committee to evaluate requests for data access

Possibility of data validation

Can validity of the data in the data source be verified (e.g., access to original medical charts)?

No

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