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 data is recorded during the medical examination carried out by the pediatrician.
Pedianet is an Italian network of more than 200 famely paediatricians (FPs) who use an established pediatric primary care database based on the Junior Bit software in their clinical practice. Data generated by Pedianet FPs are anonymized, in compliance with Italian regulations, stored in a protected “cloud” under a unique numerical identifier, and regularly checked for validation and quality control. Inclusion in the Pedianet database is voluntary; parents or legal guardians provided consent for their children’s anonymized data to be used for research purposes in accordance with national and international regulations.
Event triggering registration

Event triggering registration of a person in the data source

Practice registration

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

Death
Loss to follow up
Practice deregistration

Event triggering creation of a record in the data source

Visit to participating pediatrician
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, pre-linked

Veneto paediatricians can integrate their outpatient routine clinical care data with data from the regional vaccination registry, hospital admissions, emergency department visits, and the COVID-19 swab registry. They can access the patient's Electronic Health Records and integrate these data into their pediatric primary care database.
Data management specifications that apply for the data source

Data source refresh

Monthly

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?

No
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

2.01, 2.2

Data source ETL frequency

4,00 months

Data source ETL status

Completed