Pharmacovigilance Program from Laboratory Signals at La Paz University Hospital

19/04/2024
19/12/2025
Data source
Human
Hospital inpatient records
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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).
https://www.agpd.es/portalwebAGPD/english_resources/regulations/common/pdfs/Ley_Orgaica_15-99_ingles.pdf

Biospecimen access

Are biospecimens available in the data source (e.g., tissue samples)?

Yes

Biospecimen access conditions

Approved study

Access to subject details

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

Yes

Description of data collection

From laboratory signals of the hospital:
Laboratory signal definitions:
(1) Agranulocytosis
Neutrophils < 500/mm3, hemoglobin >10g/dl and platelets >100,000x109/L
(2) Pancytopenia
Leukocytes < 3.5 109/L, hemoglobin < 10 mg/dl platelets < 50,000 109/L
(3) Thrombocytopenia
Platelets <20 000109/L
(4) Anaemia
Hemoglobin < 6.5 with leukocytes >3.5x10e3 mcl and platelets >50e9/l
(5) Eosinophilia
Absolute and relative eosinophils > upper limit of normal (ULN)
(6) Hepatotoxicity
GPT (ALAT) x 3ULN or ALP x 2 ULN or GGT x2 ULN or BiT x2 ULN.
- Hepatocellular R (ALT/ALP) > 5.
- Cholestatic R < 2.
- or Mixed 2<R <5.
(7) Pancreatitis or mumps
Amylase x3 LSN or lipase x3 LSN
(8) Hyponatremia II**(2)
Sodium < 123 mEq/l
(9) Rhabdomyolysis
Creatine kinase (CK) x5 ULN
(10) Aute Kidney injury AKIN 3
Creatinine x3 ULN
(11) Encephalitis or meningitis
CSF Leukocytes > 10 mm3
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

Other

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

Died more than 25 years ago

Event triggering creation of a record in the data source

The event that triggers the creation of a record in the data source was the diagnosis of an adverse drug reaction.
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

Medical record number
Social security number
National identity document (Spain)

Linkage description, possible linkage

Electronic Prescriptions
Electronic dispensation
Laboratory
Pathological anatomy
Microbiology
Radiodiagnosis
Primary care
Data management specifications that apply for the data source

Data source refresh

Monthly

Informed consent for use of data for research

Waiver

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

25 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?

No

CDM Mappings