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

Any contact with patients, genetic or bio samples or other must be evaluated by the Ethics
Committee and CUF's DPO Office.

Access to subject details

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

Yes

Description of data collection

The patient data is collected through our main healthcare information system. Afterwards this data is extracted, anonymized, cleanned and structured in CUF Datalake, for management and analytical purposes.
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

Loss to follow up
Other
Practice deregistration

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

A person remains in the database unless there is an explicit intent to delete personal data, according to GDPR rules and current legislation.

Event triggering creation of a record in the data source

The trigger for creating a record is any type of encounter or touchpoint with any CUF health-related service, including outpatient and inpatient services.
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

Unique patient and record IDs are collected. These are encrypted and passed to the OMOP-CDM version to allow patient linking within sources.

Linked data source 1

Pre linked

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

Yes

Data source, other

OMOP-CDM version of the colorectal cancer data

Linkage strategy

Deterministic

Linkage variable

In the OMOP-CDM version, each patient contains a person_source_value variable that connects to the main source UID.

Linkage completeness

100% of the mapped OMOP-CDM version can be linked back

Linked data source 2

Pre linked

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

Yes

Data source, other

PRO/CRO data

Linkage strategy

Deterministic

Linkage variable

Unique patient and record IDs

Linkage completeness

100% of the mapped OMOP-CDM version can be linked back
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?

Yes

CDM Mappings

Data source ETL CDM version

5.4

Data source ETL frequency

1,00 month

Data source ETL status

Completed