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.
Shirley V WangJesper HallasWilliam CrownPeter ArlettDarren M AshcroftEric I BenchimolMarc L BergerGracy CraneWim GoettschWei HuaShaum KabadiDavid M KernXavier KurzSinead LanganTakahiro NonakaLucinda OrsiniSusanna Perez-GutthannSimone PinheiroNicole L PrattSebastian G SchneeweissMassoud ToussiRebecca J WilliamsPublished in: Pharmacoepidemiology and drug safety (2022)
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.