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.ehdn.org/hd-clinicians-researchers/data-mining-projects-2/

Biospecimen access

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

Yes

Biospecimen access conditions

All details relating to biosamples access procedures are provided on the EHDN website (https://www.euro-hd.net/html/projects/proposals/scipro)

Access to subject details

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

No

Description of data collection

Data was collected either as a paper CRF and entered onto an online EDC system or entered directly into the EDC
Event triggering registration

Event triggering registration of a person in the data source

Other

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

Consent to study participation

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

Participant request

Event triggering creation of a record in the data source

Specialist visit
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

A unique 9 digit identifier (HDID) is assigned to each participant. The HDID is used in multiple studies of Huntington's disease to link datasets (e.g Enroll-HD, Track-HD, clinical trials)

Linked data source 1

Pre linked

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

No

Data source, other

Enroll-HD

Linkage strategy

Deterministic

Linkage variable

Unique 9 digit identifier (HDID)

Linkage completeness

Complete

Linked data source 2

Pre linked

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

No

Data source, other

Track-HD

Linkage strategy

Deterministic

Linkage variable

Unique 9 digit identifier (HDID)

Linkage completeness

Complete
Data management specifications that apply for the data source

Data source refresh

Yearly

Informed consent for use of data for research

Other

Informed consent, other

All data have been consented by participants for Huntington's Disease research and development.

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?

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?

No