Comparison of electronic health records and electronic source data in clinical research trials: a retrospective review

Abstract

Accurate documentation of medications and medical history is a critical component in ensuring the integrity of subject data in clinical research trials. With a mandate to use electronic health records (EHR) in healthcare settings, there has been a parallel movement towards integrating EHR and electronic data capture (EDC) software in clinical trials to improve efficiency and accuracy of data entry. However, there is increasing evidence that EHR data tend to be erroneous. The present study is a retrospective review comparing the medications and medical history documented in the EHR versus the EDC of subjects in active, ongoing clinical research studies to assess the validity of the assumption of the utility of using EHR data directly. Our results show significant data deviation from the EHR to the EDC, where 98% of all records were modified for clarity in some capacity. Only 31.3% of all medication records were concordant, and only 45.7% of all medical problem records were concordant. This suggests that Principal Investigators play a crucial role in parsing out incomplete, inaccurate, and irrelevant information when transferring data from the EHR to the EDC.