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://www.operapadrepio.it/it/chi-siamo/organizzazione/comitato-etico

Biospecimen access

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

Yes

Biospecimen access conditions

Data may be requested to the Scientific contact. Agreements compliant with the provisions of the EU Regulation n. 2016/679 (GDPR) and Ethical Committee approvation is required. Link: https://www.operapadrepio.it/it/chi-siamo/organizzazione/comitato-etico

Access to subject details

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

Yes

Description of data collection

Data were collected on Microsoft Excel from paper format patient medical records and then transferred to SQL Server DBMS.
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

Hospitalisation

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

Other

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

Upon request from the patient

Event triggering creation of a record in the data source

Patients are recorded at hospitalisation. There is not the possibilty to create new records as the clinical study is closed in terms of recruitment but follow up data regarding mortality and kidney funtion continue to be collected.
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

Linked data source 1

Pre linked

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

No

Data source, other

SISWeb

Linkage variable

ID code

Linkage completeness

All patients in the dataset has a corresponding record in the hospital Health Information System.
Data management specifications that apply for the data source

Data source refresh

Yearly

Informed consent for use of data for research

Required for all studies

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?

Yes

CDM Mappings

Data source ETL CDM version

5.4

Data source ETL frequency

12,00 months

Data source ETL status

Completed