BIFAP - Base de Datos para la Investigación Farmacoepidemiológica en el Ámbito Público (Pharmacoepidemiological Research Database for Public Health Systems) | HMA-EMA Catalogues of real-world data sources and studies

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).

BIFAP Data Access Governance

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?: No

Description of data collection: Please see Section 3.1 'Data Collection' in GOVERNANCE DOCUMENT in: http://www.bifap.org/data-governance?lang=en

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: Upon registration with a primary care physician within the Spanish NHS (=98,9% of the Spanish population) in the 9 out of the 17 Spanish regions that contribute data

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

Event triggering creation of a record in the data source: In every encounter with the general practitioner/paediatrician. Hospital admission and pharmacy dispensation will also trigger the creation of a record.

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: BIFAP Diagnosis Tests of Covid-19

Linkage strategy: Deterministic

Linkage variable: The Personal Identification Code for the Autonomous Community (CIPA) is the variable used in the Autonomous Communities for the combination or linking of the different records for the same patient (primary care records, pharmacy dispensing records, hospital discharge diagnoses and Other Data banks). Subsequently a pseudonymisation procedure is carried out: the CIPA is eliminated by the computer technicians of the autonomous community, maintaining a pseudonymised identifier that distinguishes each patient from the Others in BIFAP. At the AEMPS, the Patient ID is finally generated from the first identifier.

Linkage completeness: Only patients included the Primary care medical records (PC-MR) and identified with a CIPA (the single linkage variable) are linked to the Other Data sources in BIFAP. Therefore, completeness is 100%. On the Other hand, any patients identified with a CIPA in Data sources (Data banks) but not having a PC-MR are not included in BIFAP.

Linked data source 2

Pre linked Is the data source described created by the linkage of other data sources?: No

Data source, other: BIFAP EMRs from Primary Care

Linkage strategy: Deterministic

Linkage variable: The Personal Identification Code for the Autonomous Community (CIPA) is the variable used in the Autonomous Communities for the combination or linking of the different records for the same patient (primary care records, pharmacy dispensing records, hospital discharge diagnoses and Other Data banks). Subsequently a pseudonymisation procedure is carried out: the CIPA is eliminated by the computer technicians of the autonomous community, maintaining a pseudonymised identifier that distinguishes each patient from the Others in BIFAP. At the AEMPS, the Patient ID is finally generated from the first identifier.

Linkage completeness: Only patients included the Primary care medical records (PC-MR) and identified with a CIPA (the single linkage variable) are linked to the Other Data sources in BIFAP. Therefore, completeness is 100%. On the Other hand, any patients identified with a CIPA in Data sources (Data banks) but not having a PC-MR are not included in BIFAP.

Linked data source 3

Pre linked Is the data source described created by the linkage of other data sources?: No

Data source, other: BIFAP Hospital Diagnosis at in patients discharge

Linkage strategy: Deterministic

Linkage variable: The Personal Identification Code for the Autonomous Community (CIPA) is the variable used in the Autonomous Communities for the combination or linking of the different records for the same patient (primary care records, pharmacy dispensing records, hospital discharge diagnoses and Other Data banks). Subsequently a pseudonymisation procedure is carried out: the CIPA is eliminated by the computer technicians of the autonomous community, maintaining a pseudonymised identifier that distinguishes each patient from the Others in BIFAP. At the AEMPS, the Patient ID is finally generated from the first identifier.

Linkage completeness: Only patients included the Primary care medical records (PC-MR) and identified with a CIPA (the single linkage variable) are linked to the Other Data sources in BIFAP. Therefore, completeness is 100%. On the Other hand, any patients identified with a CIPA in Data sources (Data banks) but not having a PC-MR are not included in BIFAP.

Linked data source 4

Pre linked Is the data source described created by the linkage of other data sources?: No

Data source, other: BIFAP Medicines Dispensed at Community Pharmacies

Linkage strategy: Deterministic

Linkage variable: The Personal Identification Code for the Autonomous Community (CIPA) is the variable used in the Autonomous Communities for the combination or linking of the different records for the same patient (primary care records, pharmacy dispensing records, hospital discharge diagnoses and Other Data banks). Subsequently a pseudonymisation procedure is carried out: the CIPA is eliminated by the computer technicians of the autonomous community, maintaining a pseudonymised identifier that distinguishes each patient from the Others in BIFAP. At the AEMPS, the Patient ID is finally generated from the first identifier.

Linkage completeness: Only patients included the Primary care medical records (PC-MR) and identified with a CIPA (the single linkage variable) are linked to the Other Data sources in BIFAP. Therefore, completeness is 100%. On the Other hand, any patients identified with a CIPA in Data sources (Data banks) but not having a PC-MR are not included in BIFAP.

Linked data source 5

Pre linked Is the data source described created by the linkage of other data sources?: No

Data source, other: BIFAP Vaccines Covid-19 administered National Registry

Linkage strategy: Deterministic

Linkage variable: The Personal Identification Code for the Autonomous Community (CIPA) is the variable used in the Autonomous Communities for the combination or linking of the different records for the same patient (primary care records, pharmacy dispensing records, hospital discharge diagnoses and Other Data banks). Subsequently a pseudonymisation procedure is carried out: the CIPA is eliminated by the computer technicians of the autonomous community, maintaining a pseudonymised identifier that distinguishes each patient from the Others in BIFAP. At the AEMPS, the Patient ID is finally generated from the first identifier.

Linkage completeness: Only patients included the Primary care medical records (PC-MR) and identified with a CIPA (the single linkage variable) are linked to the Other Data sources in BIFAP. Therefore, completeness is 100%. On the Other hand, any patients identified with a CIPA in Data sources (Data banks) but not having a PC-MR are not included in BIFAP.

Linked data source 6

Pre linked Is the data source described created by the linkage of other data sources?: No

Data source, other: Causes of Death national registry

Linkage strategy: Deterministic

Linkage variable: The Personal Identification Code for the Autonomous Community (CIPA) is the variable used in the Autonomous Communities for the combination or linking of the different records for the same patient (primary care records, pharmacy dispensing records, hospital discharge diagnoses and Other Data banks). Subsequently a pseudonymisation procedure is carried out: the CIPA is eliminated by the computer technicians of the autonomous community, maintaining a pseudonymised identifier that distinguishes each patient from the Others in BIFAP. At the AEMPS, the Patient ID is finally generated from the first identifier.
In the Causes of Death national registry persons personal identifiers are different from the CIPA. Therefore, an additional linkage process of the CIPA and the personal identifiers in the Causes of Death national registry (national identitiy number and Others) is performed by the autonomous regions.

Linkage completeness: Only patients included the Primary care medical records (PC-MR) and identified with a CIPA (the single linkage variable) are linked to the Other Data sources in BIFAP. Therefore, completeness is 100%. On the Other hand, any patients with a record in the Cause of Death national registry but not having a PC-MR are not included in BIFAP.

Linked data source 7

Pre linked Is the data source described created by the linkage of other data sources?: No

Data source, other: Hospital Pharmacies dispensing Data

Linkage strategy: Deterministic

Linkage variable: The Personal Identification Code for the Autonomous Community (CIPA) is the variable used in the Autonomous Communities for the combination or linking of the different records for the same patient (primary care records, pharmacy dispensing records, hospital discharge diagnoses and Other Data banks). Subsequently a pseudonymisation procedure is carried out: the CIPA is eliminated by the computer technicians of the autonomous community, maintaining a pseudonymised identifier that distinguishes each patient from the Others in BIFAP. At the AEMPS, the Patient ID is finally generated from the first identifier.

Linkage completeness: Only patients included the Primary care medical records (PC-MR) and identified with a CIPA (the single linkage variable) are linked to the Other Data sources in BIFAP. Therefore, completeness is 100%. On the Other hand, any patients identified with a CIPA in Data sources (Data banks) but not having a PC-MR are not included in BIFAP.

Data management specifications that apply for the data source

Data source refresh: Every 6 months

Informed consent for use of data for research: Not Required

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

Data source last refresh: 31/12/2023

Common Data Model (CDM) mapping

CDM mapping Has the data source been converted (ETL-ed) to a common data model?: Yes

CDM Mappings

CDM name: BIFAP

CDM website: http://www.bifap.org/docs/BIFAP_Data_Access_Governance_v2_2021_20211011_with%20…

CDM release frequency: 6 months

Data source ETL CDM version: 1.0

Data source ETL frequency: 2,00 months

Data source ETL status: Completed

CDM name: ConcepTION CDM

CDM website: https://www.imi-conception.eu/

CDM release frequency: 6 months

Data source ETL CDM version: For ConcepTION each study implies one or more ETL and different versions of the CDM can be used in different moments.

Data source ETL frequency: 6,00 months

Data source ETL status: Completed

CDM name: OMOP

CDM website: https://www.ohdsi.org/Data-standardization/

Data source ETL CDM version: 5.4

Data source ETL frequency: 6,00 months

Data source ETL status: Completed

BIFAP - Base de Datos para la Investigación Farmacoepidemiológica en el Ámbito Público (Pharmacoepidemiological Research Database for Public Health Systems)

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