rwevalidate - Validate Patient Cohorts for Real-World Evidence Studies on the
OMOP Common Data Model
Validates instantiated patient cohorts on an Observational
Medical Outcomes Partnership (OMOP) Common Data Model (CDM)
database for real-world-evidence (RWE) studies. From a single
function call it produces a structured validation report in
Hypertext Markup Language (HTML) and JavaScript Object Notation
(JSON) covering concept coverage, cohort attrition, temporal
data density, and covariate feasibility against a comparator.
The checks are aligned with the United States Food and Drug
Administration (FDA) guidance on real-world data and evidence,
FDA (2023) <https://www.fda.gov/media/171667/download>, the
Harmonized Protocol Template to Enhance Reproducibility
(HARPER), Wang and others (2022) <doi:10.1002/pds.5507>, and
the Reporting of Studies Conducted Using Observational
Routinely-Collected Data for Pharmacoepidemiology (RECORD-PE)
statement, Langan and others (2018) <doi:10.1136/bmj.k3532>. A
self-contained example database is bundled so the checks can be
run without a live database connection.
