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 reuse will be mediated by the ECRAID-Base DAC

Access to subject details

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

No

Description of data collection

The POSs in ECRAID-Base collect study-specific, participant-level data using dedicated electronic Case Report Forms (eCRF) implemented using the CASTOR electronic data capture (EDC) system.
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

Eligibility criteria met and Informed consent obtained

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

Death
Other

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

Discharge, End of study period, Withdrawal

Event triggering creation of a record in the data source

Eligibility criteria met and Informed consent obtained
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

Linkage description, pre-linked

In POS-Disease X, the routine diagnostics assay data from the study site's local laboratory information management system (LIMS) will be exported and directly uploaded to the UMCU digital research environment (DRE) by the local study site team

Linkage description, possible linkage

Patient samples collected in the POSs will be transferred to the Laboratory of Medical Microbiology of the University of Antwerp (UA) for long-term storage and further analysis in the "Biobank Antwerp" (BB190007).

Patient samples will be registered with a unique sample ID in the laboratory information management system (ClinSLIMS) used at the Laboratory of Medical Microbiology of the University of Antwerp
Additional sample analyses will be performed at the central Lab (i.e. University of Antwerp) and the analysis results will be uploaded to the UMCU DRE. This data can be linked with the participant-level clinical data from the eCRFs

Linked data source 1

Pre linked

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

No

Data source, other

Biobank Antwerp

Linkage variable

Unique Subject ID and sample ID

Linked data source 2

Pre linked

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

Yes

Data source, other

Laboratory information management system (LIMS)

Linkage variable

Unique Subject ID
Data management specifications that apply for the data source

Data source refresh

Monthly

Informed consent for use of data for research

Other

Informed consent, other

Participants provide broad consent for future use. Intervention studies require specific consents.

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

6,00 months

Data source ETL status

In progress

Data source ETL specifications (link)