Electronic Health Records
Overview
Chair:
Core goal: Facilitate multisite research collaborations between investigators and data stewards.
The ability to harness real-world data is transforming the way clinical research is conducted. Over the years, the Electronic Health Records (EHR) Core has expanded its focus to encompass the use of real-world data and technologies in embedded pragmatic clinical trials (ePCTs). Sources of real-world data include electronic health records, administrative claims, patient-reported outcomes (PROs), patient-generated health data, and medical product and device registries, as well as databases relating to environmental factors or social determinants of health. 
EHR Core members have authored Living Textbook chapters about:
Tools
Assessing Fitness-for-Use of Clinical Data for PCTs
This document highlights recommendations for assessing the fitness-for-use of data generated from routine patient care for use in PCTs.
Sample Data Use Agreement (DUA)
Example DUA from the National Library of Medicine
Learning Modules
Healthcare Data Interoperability and Standardization for Research
The learning module comprises 2 new learning topic videos, “The Big Picture: Healthcare Data and Interoperability” and “Common Data Models.”
How Do I Define Outcomes With Electronic Health Record Data?
This collection of videos describes challenges of using EHR data, key factors in using EHR data for endpoints and outcomes, computable phenotypes, and benefits of standardizing phenotype definitions.
- What Are the Challenges of Using Data Directly From the EHRs?
- What Is a Computable Phenotype?
- What Are the Benefits to Standardizing Phenotype Definitions?
- What Are the Key Factors in Using EHR Data for Endpoints and Outcomes?
Workshops
Advances at the Intersection of Digital Health, EHRs, and PCTs: NIH-Hosted Workshop (May-July 2020)
The NIH Collaboratory Grand Rounds held a special workshop series to explore challenges and opportunities in using electronic health records (EHRs) in pragmatic clinical trials.
Data and Resource Sharing
NIH Pragmatic Trials Collaboratory Data and Resource Sharing
This page contains access to all elements of the NIH Collaboratory Trials' final data and resource sharing packages.
This checklist guides investigators through the necessary steps to comply with the HEAL Public Access and Data Sharing Policy. Investigators at all stages of their HEAL awards are encouraged to read through each section of the roadmap to ensure you are aware of each step and their accompanying resources.
HEAL-Compliant Repository Selection Guide
List of compliant destinations for HEAL data, with links to repositories and re3data/FAIRsharing entries with objective summaries of repository attributes.
Areas of Focus
- Data sharing
- Data Interoperability and Standardization
- Use of real-world data
- Data quality
- Computable Phenotypes
- Acquiring Data
Interview
During the NIH Pragmatic Trials Collaboratory 2024 Steering Committee meeting, Drs. Keith Marsolo and Rachel Richesson discussed challenges in data access, management, and quality in pragmatic clinical trials.
News and Interviews
- News_A Year of Trial Results and Innovations From the NIH Pragmatic Trials Collaboratory
December 15, 2025: A Year of Trial Results and Innovations From the NIH Pragmatic Trials Collaboratory
- News_Podcast Episode Takes Listeners Behind the Scenes of New Learning Module
July 30, 2025: Podcast Episode Takes Listeners Behind the Scenes of New Learning Module
- Podcast 53_Healthcare Data Interoperability and Standardization for Research
Podcast 53: Healthcare Data Interoperability and Standardization for Research
- News_How to Choose Patient-Reported Outcome Measures in Pragmatic Clinical Trials
June 23, 2025: How to Choose Patient-Reported Outcome Measures in Pragmatic Clinical Trials?
- News_New NIH Collaboratory Learning Module Explores Challenges and Possibilities of Working With Electronic Health Record Data
May 28, 2025: New NIH Collaboratory Learning Module Explores Challenges and Possibilities of Working With Electronic Health Record Data
- News_A Year of Innovations and Insights From the NIH Pragmatic Trials Collaboratory
December 12, 2024: A Year of Innovations and Insights From the NIH Pragmatic Trials Collaboratory
- News_NIH Collaboratory Trial Investigators Share Lessons From Using Electronic Health Records in Pragmatic Trials
November 25, 2024: NIH Collaboratory Trial Investigators Share Lessons From Using Electronic Health Records in Pragmatic Trials
- News_New Living Textbook Contribution Explains Differences Between Medicare Data Sources
October 28, 2024: New Living Textbook Contribution Explains Differences Between Medicare Data Sources
- News_EHR Core and Patient-Centered Outcomes Core Reflect on Challenges in Pragmatic Trials
August 13, 2024: EHR Core and Patient-Centered Outcomes Core Reflect on Challenges in Pragmatic Trials
- News_Pragmatic Trials Researchers Share Lessons From Collecting Patient-Reported Outcomes in the Electronic Health Record
January 8, 2024: Pragmatic Trials Researchers Share Lessons From Collecting Patient-Reported Outcomes in the Electronic Health Record
Products and Publications
- Marsolo et al Contemp Clin Trials 2024
Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials
- Zigler et al Contemp Clin Trials 2023
Collecting patient-reported outcome measures in the electronic health record: Lessons from the NIH Pragmatic Trials Collaboratory
- Boyd et al J Am Med Inform Assoc 2023
Potential bias and lack of generalizability in electronic health record data: reflections on health equity from the National Institutes of Health Pragmatic Trials Collaboratory
- Handout-Assessing-Fitness-for-Use of-Clinical-Data-for-PCTs
Assessing Fitness-for-Use of Clinical Data for PCTs
- Richesson et al J Am Med Inform Assoc 2021
Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory
- Living Textbook Chapter_Assessing Fitness-for-Use of Real-World Data Sources
Living Textbook Chapter: Assessing Fitness-for-Use of Real-World Data Sources
- Living Textbook Chapter_Acquiring Real-World Data
Living Textbook Chapter: Acquiring Real-World Data
- Living Textbook Chapter_Clinical Decision Support
Living Textbook Chapter: Clinical Decision Support
- Living Textbook Chapter_Electronic Health Records-Based Phenotyping
Living Textbook Chapter: Electronic Health Records-Based Phenotyping
- Rockhold et al JAMIA 2020
ADAPTABLE Supplement Publication: Design and analytic considerations for using patient-reported health data in pragmatic clinical trials: report from an NIH Collaboratory roundtable
Presentations
- EHR Slides OCT2025
Onboarding Meeting Oct. 29, 2025 - EHR Core Intro
- EHR Slides 28OCT2025
Onboarding Meeting October 28, 2025 - EHR Core Intro
- GR-Video-10-17-25
Making Effective Use of Data Infrastructure in PCORnet®
- GR-Slides-10-17-25
Making Effective Use of Data Infrastructure in PCORnet®
- 00_Marsolo_combined_FINAL 2
Demystifying Data Sharing
- 00_George_Improving Implementation of Digital Tools_Final_Includes all slides
Improving Implementation of Digital Tools Developed in ePCTs
- EHR Core Slides JAN2025
Onboarding Meeting January 2025 - EHR Core Intro
- EHR Core Slides NOV2024
Onboarding Meeting November 2024 - EHR Core Intro
- EHR_Core Onboarding Slides_18OCT2024_Final
Onboarding Meeting October 2024 - EHR Core Intro
- Introduction to the NIMH Data Archive (Video 2024)
Introduction to the NIMH Data Archive (Video 2024)