HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real‐world evidence studies on treatment effects: A good practices report of a joint ISPE/ISPOR task force

Abstract

The HARmonized Protocol Template to Enhance Reproducibility (HARPER) helps to create a shared understanding of intended scientific decisions through a common text, tabular and visual structure. The template provides a set of core recommendations for clear and reproducible RWE study protocols and is intended to be used as a backbone throughout the research process from developing a valid study protocol, to registration, through implementation and reporting on those implementation decisions.