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).
COMPERA Home Page

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

Data are entered into the central database by registered centres. In order to collect adequate data on PAH/PH treatment in routine clinical care, the COMPERA registry has been prospectively documenting consecutive patients with newly initiated treatment for PAH/PH since May 2007 (since 2014 mainly patients with newly diagnosed disease). The web-based registry meets high quality standards through several measures (planned minimum centre contribution of at least 10 patients per year, automated plausibility checks of data at entry, queries, monitoring with source data verification in >50% of participating centres).
Event triggering registration

Event triggering registration of a person in the data source

Disease diagnosis

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

Withdrawal of patient consent

Event triggering creation of a record in the data source

Diagnosis of Pulmonary (Arterial) Hypertension
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

Linkage description, possible linkage

The data source may potentially be linked with additional data sources, such as for comparisons with other registries; however, the specific methods for such linkage are yet to be defined.
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

If pseudonymized data is used for purposes not originally covered in the patient information, ethics committees might require obtaining new informed consent from patients for these new purposes.

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

15 years

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