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).
http://www.smartcare.de

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

After site initiation, documenting users apply for a user account for the EDC-system Insight by OpenApp ltd., users login in with username and password into EDC-system to document Enrolment, Baseline and following visits until End of Data Collection; PRO included in Medical Assessment
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

Filled in patient informed consent

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

Death
Emigration
Loss to follow up

Event triggering creation of a record in the data source

Specialist encounter, medicinal product dispensing, AE
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

Double pseudonymisation of data and creation of unique identifiers for FAIRification process. We use the "FAIR in an box" tool to produce data in RDF format and provide them on a graph database. We use a FAIR Data point for linkage of metadata. Once spider pseudonymization service is set up, we will use spider's probablistic (firstname, lastname, dob) pseudonym generation for record linkage.

Linked data source 1

Pre linked

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

No

Data source, other

EURO-NMD (https://ern-euro-nmd.eu/)

Linkage strategy

Probabilistic

Linkage variable

We will use spider's generated pseudonyms in the future.

Linkage completeness

It depends on the required variables; many variables in EURO-NMD are more applicable to other NMD registries, so not all the variables can be linked to SMArtCARE.
Data management specifications that apply for the data source

Informed consent for use of data for research

Other

Informed consent, other

There is a committee to evaluate requests for data access

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

10 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

CDM name (other)

Set of common data elements for rare diseases registration

Data source ETL status

Not ETL-ed

Data source ETL specifications (link)