Traditional data collection for clinical trials can be cumbersome and inefficient. FDA guidance now promotes capturing clinical trial source data in electronic form and transmitting it to the EDC, recognizing that this should reduce double data entry and improve data quality and timeliness. Electronic data originators can include the EHR, which can be used during routine clinical care and for gathering data during a clinical investigation. We evaluated a pilot of structured EHR data transfer to EDC in a clinical trial setting.
Find the abstract for this project here.