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://amplitude-clinical.com/

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

Patient and clinician reported surveys
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

End of treatment
Death

Event triggering creation of a record in the data source

Automated (Once when registered, then automatically 6 weeks, 6 months, then annually for up to 10 years)
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

Informed consent for use of data for research

Other

Informed consent, other

There is a committee to evaluate requests for data access. Ethical approval required if data is shared outside of ICRS.

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
Common Data Model (CDM) mapping

CDM mapping

Has the data source been converted (ETL-ed) to a common data model?

No