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)?

No

Access to subject details

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

Yes

Description of data collection

Participating centers enter data from patient records to an online eCRF created by TriNetX Oncology GmbH in the current version of secuTrial™ (iAS GmbH, Berlin, Germany). Participant selection is driven by the distribution of the number of MM patients in the relevant health care sectors (university hospitals, non-university hospitals, office-based practice) obtained from in-house health care structure analyses. The documenting physician transfers the existing data from the patient file to the online documentation form retrospectively from the current point in time (end of the observation period) to the initial diagnosis of the disease.
Event triggering registration

Event triggering registration of a person in the data source

Start of treatment

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's who have been de-registered remain in the database for retrospectice and longitudinal analyses.

Event triggering creation of a record in the data source

New patient meeting the inclusion criteria is reported via eCRF by the participating physician
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

Quarterly

Informed consent for use of data for research

Not Required

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

6,00 months

Data source ETL status

Completed