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Living Textbook of
Pragmatic Clinical Trials

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Rethinking Clinical Trials

A Living Textbook of Pragmatic Clinical Trials

  • Design
    • What is a Pragmatic Clinical Trial?
    • Decentralized Pragmatic Clinical Trials
    • Developing a Compelling Grant Application
    • Experimental Designs and Randomization Schemes
    • Endpoints and Outcomes
    • Analysis Plan
    • Using Electronic Health Record Data
    • Building Partnerships and Teams to Ensure a Successful Trial
    • Intervention Delivery and Complexity
    • Patient Engagement
  • Data, Tools & Conduct
    • Assessing Feasibility
    • Acquiring Real-World Data
    • Assessing Fitness-for-Use of Real-World Data
    • Study Startup
    • Participant Recruitment
    • Monitoring Intervention Fidelity and Adaptations
    • Patient-Reported Outcomes
    • Clinical Decision Support
    • Mobile Health
    • Electronic Health Records–Based Phenotyping
    • Navigating the Unknown
  • Dissemination & Implementation
    • Data Sharing and Embedded Research
    • Dissemination Approaches for Different Audiences
    • Implementation
    • End-of-Trial Decision-Making
  • Ethics & Regulatory
    • Privacy Considerations
    • Identifying Those Engaged in Research
    • Collateral Findings
    • Consent, Disclosure, and Non-Disclosure
    • Data and Safety Monitoring
    • Ethical Considerations of Data Sharing in Pragmatic Clinical Trials
    • Ethics for AI and ML
    • IRB Responsibilities and Procedures

The Research Question Drives the Data Requirements

CHAPTER SECTIONS

Using Electronic Health Record Data in Pragmatic Clinical Trials


Section 9

The Research Question Drives the Data Requirements

Expand Contributors
Rachel Richesson, MS, PhD, MPH
Richard Platt, MD, MSc
Gregory Simon, MD, MPH
Lesley Curtis, PhD
Reesa Laws, BS
Adrian Hernandez, MD, MSH
Jon Puro, MPA-HA
Doug Zatzick, MD
Erik van Eaton, MD, FACS
Vincent Mor, PhDKeith A Marsolo, PhD

Contributing Editor
Karen Staman, MS

Using data from existing EHR systems (rather than prospectively collecting new data explicitly for the trial) generally entails trading control for efficiency. That loss of control often involves some sacrifices, which are sometimes acceptable to the research team and sometimes unacceptable, depending on the study and its aims. To determine what trade-offs are acceptable for a given study, the investigator must begin with a very clear idea of the specific information needs for the trial (e.g. assess baseline characteristics) and then assess how much study integrity would be lost by using existing records data rather than attempting to collect new data. If using EHR data will support the data requirements for the study in a way that ensures integrity of the data and subsequent results, then researchers should take steps to ensure that possible errors, biases, and variation can be identified and minimized. As with any research study, and to be consistent with Good Clinical Practices for research, investigators should clearly define and collect only the “minimum necessary” data for the trial, and conduct quality assessments for all of the data being used, usually at multiple timepoints (for more on data quality reporting recommendations. Ultimately, as in all research, the scientific research question provides the foundation that will guide all decisions and activities of PCT research design and implementation, including the appropriate and optimal use of EHR systems and data.

Previous Section Next Section

SECTIONS

CHAPTER SECTIONS

sections

  1. Introduction
  2. Interoperability
  3. Data as a Surrogate for Clinical Phenomena
  4. Developing and Refining the Research Questions
  5. Specific Uses for EHR Data in PCTs
  6. Estimating and Identifying the Study Population and Assessing Baseline Prognostic Characteristics
  7. Implementing and Monitoring the Delivery of an Intervention
  8. Assessing Outcomes
  9. The Research Question Drives the Data Requirements
  10. Additional Resources


Version History

October 7, 2025: Updated text as part of annual review (changes made by K. Staman).

July 3, 2020: Minor corrections to layout and formatting (changes made by D. Seils).

Published August 25, 2017

current section :

The Research Question Drives the Data Requirements

  1. Introduction
  2. Interoperability
  3. Data as a Surrogate for Clinical Phenomena
  4. Developing and Refining the Research Questions
  5. Specific Uses for EHR Data in PCTs
  6. Estimating and Identifying the Study Population and Assessing Baseline Prognostic Characteristics
  7. Implementing and Monitoring the Delivery of an Intervention
  8. Assessing Outcomes
  9. The Research Question Drives the Data Requirements
  10. Additional Resources

Citation:

Richesson R, Platt R, Simon G, et al. Using Electronic Health Record Data in Pragmatic Clinical Trials: The Research Question Drives the Data Requirements. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at: https://rethinkingclinicaltrials.org/chapters/design/using-electronic-health-record-data-pragmatic-clinical-trials-top/research-question-drives-data-requirements/. Updated October 7, 2025. DOI: 10.28929/037.

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