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

The AIFA monitoring registries Platform is a national network the use of which is mandatory for clinicians to prescribe a monitored medicinal product within a specific therapeutic indication and inside the Italian National Health Service reimbursement framework (SSN). Pharmacists access the wMRs as well and are responsible to insert all data regarding drug dispensation and managed entry agreements. Given the fact that most of medicinal products monitored throughout the wMRs are innovative and high cost, we are confident that the registries capture about 100% of the treated population.

From an administrative point of view, regional representatives can enable health centers and ward in their territory. Moreover, each region has the duty to perform an administrative control on the data quality.
Event triggering registration

Event triggering registration of a person in the data source

Other
Start of treatment

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

Eligibility to a given treatment

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

Other

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

De-registration occurs only in case of errors in patients registration for data quality management. A new registration is then required.

Event triggering creation of a record in the data source

Medical doctors fill in the demographic and eligibility forms for each patient before treatment start, this generates a record for the patient in the wMRs.
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

Not Required

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?

Yes
Common Data Model (CDM) mapping

CDM mapping

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

No