Abstract: Traditional clinical trials are increasingly taking advantage of Real World Data. Embedded pragmatic clinical trials import routinely collected EHR data as much as possible rather than collecting it traditionally via Case Report Forms. We studied what routine care EHR data elements can be used in a research and the most optimal approach to combine EHR and research data at study completion.

Describe the new knowledge and additional skills the participant will gain after attending your presentation.: Participants will be able to: (1) design a research study that optimally combines data from Electronic Health Record (EHR) and research Electronic Data Capture (EDC); (2) use a data sharing format that facilitates data re-use of de-identified individual participant data when the study is completed; (3) understand existing research Common Data Element initiatives and their relationship to routine healthcare terminologies, such as SNOMED CT or LOINC and routine healthcare standards, such as Fast Healthcare Interoperability Resources (FHIR).

Authors:

Vojtech Huser (Presenter)
National Institutes of Health

Craig Mayer, National Institutes of Health
Nick Williams, National Institutes of Health