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://www.erknet.org/patients-registry/registry-governance

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?

No

Description of data collection

Data is collected and entered by trained medical staff at each contributing site into online case report forms accessible through the registry website (www.registry.erknet.org). Conditional data entry menus are displayed based on the clinical diagnosis and patient age (pediatric or adult).
Automated data entry checks using pre-defned plausibility ranges prevent saving of biologically or technically implausible data. As a second layer of quality control, more refned data consistency evaluations are performed and queries sent at regular intervals (e.g. implausible results for KPIs)
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

Informed conset

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

Death
Loss to follow up
Other

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

patient opt-out, Transition to adult unit, Transition to other center

Event triggering creation of a record in the data source

All patients with a primary rare disease of the kidney or a syndromic disease associated with kidney manifestations are eligible for inclusion in the registry, irrespective of current age, age at disease presentation, disease duration, current kidney function and treatment status (conservative, dialysis, kidney transplantatation).

Each patient visit is registered. These can happen voluntarily, as regular check-ups, or as requested by the healthcare provider. It is possible that visits are not recorded immediately in the registry. If no follow-up is recorded within a year of a patient's last visit, the healthcare provider will be contacted and encouraged to either enter data from non-recorded visits or to arrange a new appointment.
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?

No
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)?

Yes

Data source preservation

Are records preserved in the data source indefinitely?

No

Data source preservation length

15 years

Approval for publication

Is an approval needed for publishing the results of a study using the data source?

Yes
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 status

In progress