Evaluating Fitness-for-Use of Electronic Health Records in Clinical Research 

PI(s): Emily O’Brien and Laura Qualls, Duke University 

Project Summary: This substudy has three main objectives:

1. Develop a framework to support site-level transformation of research-ready real-world data (RWD) to fit-for-purpose RWD through a review of existing literature and an analysis of the curation processes for several ongoing and recently completed pragmatic trials.
2. Explore the use of RWD to auto-populate baseline clinical characteristics for trial participants.
3. Explore the use of RWD to ascertain and classify clinical events of interest during longitudinal trial follow-up

Study Design: Multi-CRN Data only Observational

PaTH Partners:

• Aiyer Arian

Coordinating Center: Duke University