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

Country EMR or bespoke systems and Electronic Data Capture systems using OpenClinica and REDCap
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

ISAR agreement

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

Other

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

If country asks for patient withdrawal, if country withdraws

Event triggering creation of a record in the data source

Clinic review
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, pre-linked

ISAR is using an electronic data capture system (EDC) that builds an anonymized database of severe asthma patients. ISAR data can be potentially linked into the EMR databases in some of the participating countries.

Linkage description, possible linkage

ISAR is using an electronic data capture system (EDC) that builds an anonymized database of severe asthma patients. ISAR data can be potentially linked into the EMR databases in some of the participating countries.

Linked data source 1

Pre linked

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

Yes

Data source, other

All countries hold linkage of ISAR patient ID and actually patient identifiers (eg. NHS number) at their own local site so we do not have access to PID details.

Linkage strategy

Deterministic

Linkage variable

ISAR ID (non PID variable)

Linkage completeness

ISAR ID maps to the unique patient identifier but this is kept local to the site sending the data and we do not have access to this.
Data management specifications that apply for the data source

Data source refresh

Every 6 months

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?

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?

No