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).
See tab 'Project Management'

Biospecimen access

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

No

Access to subject details

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

Yes

Description of data collection

Data is collected and entered by trained medical staff at each Health Care Provider into the central database. The Castor database is used to store the data. For each patient, information about the Informed Consent is gathered, as well as the Common Data Elements that were developed by the EJP RD. Based on the diagnosis of the patient, specific clinical questions need to be filled out as well. Soon, patients will receive surveys to fill out themselves.
Event triggering registration

Event triggering registration of a person in the data source

Disease diagnosis
Other

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

Signed Informed Consent

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

Other

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

Withdrawal of Informed Consent

Event triggering creation of a record in the data source

All patients with a rare uro-recto-genital disease that falls under the scope of the ERN eUROGEN Expertise Areas are eligible for inclusion in the registry. Informed consent is mandatory.
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

Linkage with other data sources using the Common Data Elements (SPIDER pseudonym) as developed by the Joint Research Centre (JRC)
Data management specifications that apply for the data source

Data source refresh

Monthly

Informed consent for use of data for research

Required for general use

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