The Research Question Drives the Data Requirements

Using Electronic Health Record Data in Pragmatic Clinical Trials

Section 8

The Research Question Drives the Data Requirements


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, 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 to 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, see Assessing Data Quality for Healthcare Systems Data Used in Research). 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.



Version History

Published August 25, 2017


Richesson R, Platt P, 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 Health Care Systems Research Collaboratory. Available at: Updated November 13, 2018. DOI: 10.28929/037.