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Technology-enabled clinical trials: Intentional capture of source data in the electronic-health record and direct transfer to trial database in a phase II multicenter trial

May 25, 2023


Collecting data for clinical trials using traditional methods can be tedious and inefficient. FDA guidelines encourage the adoption of electronic capture methods from source data for clinical trials to reduce duplicate data entry and enhance the accuracy and speed of data processing. Electronic health records (EHRs) are one such data originator that can be leveraged both during routine clinical care and for research purposes. 

This study focuses on a pilot implementation of transferring structured EHR data to an electronic data capture (EDC) system in a Phase II multicenter clinical trial. 

Why this matters

The adoption of EHR-to-EDC methods for clinical trial source data capture can eliminate the need for manual transcription and duplicate data entry into electronic case report forms, potentially improving efficiency and accuracy. Moreover, the use of EHR data for clinical trials could facilitate more rapid access to data stored in the EDC system. 

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