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)?

Yes

Biospecimen access conditions

Biospecimen available in the context of an approved study protocol upon dedicated agreements

Access to subject details

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

Yes

Description of data collection

To collect or process data, a clinical protocol needs to be submitted and approved to an Institutional Review Board (IRB) and subsequently also approved by Azienda Ospedaliero Universitaria of Modena (about 4 weeks for approval). The request for approval goes in parallel for IRB and Azienda Ospedaliero Universitaria. Link: https://www.aou.mo.it/ComitatoEticoAVEN
Any events related to diagnosis, start or modification of therapy, events related to the patient's medical history (toxicity, disease progression) are recorded in the platform
The Modena Cancer Center (Centro Oncologico Modenese - COM) of the AOU Policlinico (Modena, Italy) annually takes care of several thousand patients affected by solid tumors. All patients are followed within specific diagnostic-therapeutic paths for the pathology. All histopathological data, radiological staging documents (US, CT scan, MRI, PET/SPECT), all therapies (chemo, immunotherapies, radiotherapy, target therapies, hormonal therapies) and survival outcomes are stored in an electronic medical platform (COMnet). This platform is also integrated with laboratory assessments (heamatological. biochemical, microbiological, serological).
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

Practice deregistration

Event triggering creation of a record in the data source

Diagnosis of cancer or taking charge of an already diagnosed patient
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

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
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

Data source ETL specifications (link)