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.msregister.de/forschung/nutzung-von-registerdaten-use-and-access/

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

In the majority of our centers, staff logins into our research database using individual accounts and then enters data on their centers pwMS population using the pseudonym generated by the central trusted 3rd party. Data collection by patients can be enabled by the centers using either individual accounts details or visit specific tokens provided to the patients as qr-codes or email links.
Event triggering registration

Event triggering registration of a person in the data source

Disease diagnosis
Practice registration

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

Death
Emigration
Other

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

Patient revokes ICF

Event triggering creation of a record in the data source

Specialist encounter
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

Health insurance data: Via a trusted 3rd party we can link between the registry and other data sources by employing probabilistic matching on the identifying data (e.g. names, date of birth, sex and diagnosis code). IRB confirmation is needed.
Regims-registry: linkage is possible through deterministic matching using patient common ID.

Linked data source 1

Pre linked

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

No

Data source, other

Health insurance data

Linkage strategy

Probabilistic

Linkage variable

Not applicable (multiple variables used in probabilistic linkage strategy)

Linkage completeness

Completness will depend on the number of insurers included in the linkage.

Linked data source 2

Pre linked

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

No

Data source, other

Regims-registry

Linkage strategy

Deterministic

Linkage variable

Common ID

Linkage completeness

Completness will depend on the number of insurers included in the linkage.
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?

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

5.3.1

Data source ETL status

Completed