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

Upon request and approval by the local Ethics Committee / Clinical Academic Center Direction Board

Access to subject details

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

Yes

Description of data collection

Each type of data is collected using a different information system/electronic record. Support staff, nurses, medical doctors, and allied health professionals are involved to input data. Each information system/electronic uses a different database that associates a patient's unique ID number to the collected data. Data from several databases is collected in a unique database (master_database), using the patient's unique ID to interlink the information. Details on the specific information system/electronic are provided as follows:
i) Slinico software » Sclinico_database (medical, nursing, ancillary studies data); ii) RNU » RNU_database (administrative data); iii) PEM software » PEM_database (prescription data).
Event triggering registration

Event triggering registration of a person in the data source

Start of treatment

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

Death

Event triggering creation of a record in the data source

Provision of care, for the first time, inside the hospital. The record is created by the administrative support staff when the patient does the check-in.
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

Each patient has a unique patient ID (ID variable) that corresponds to the number of the citizenship ID card or passport. This a unique number, therefore no duplicates can occur.
The ID variable will be associated to all the events (e.g., procedure, appointment, administrative task, prescriptions) recorded on the databases previouly mentioned (Sclinico_database; RNU_database; PEM_database).
This ID variable is used to assemble a unique database that includes all the data recorded, for each patient, in the previouly mentioned databases.

Linked data source 1

Pre linked

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

Yes

Data source, other

PEM_database

Linkage strategy

Deterministic

Linkage variable

Unique patient ID

Linkage completeness

10000.00%

Linked data source 2

Pre linked

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

No

Data source, other

RNU_database

Linkage strategy

Deterministic

Linkage variable

Unique patient ID

Linked data source 3

Pre linked

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

No

Data source, other

Sclinico_database

Linkage strategy

Deterministic

Linkage variable

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

Data source refresh

Every 6 months

Informed consent for use of data for research

Required for intervention 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?

No

Data source preservation length

50 years

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

1

Data source ETL frequency

6,00 months

Data source ETL specifications (file)

Data source ETL status

In progress