Automating Data Entry from Electronic Health Record to Electronic Data Capture Using a Trusted Cloud-Based Application in Multisite Cancer Clinical Trials.

Introduction: For more than two decades, researchers have sought to develop and to improve technologies to seamlessly move data from electronic health record (EHR) systems to study forms in electronic data capture (EDC) systems. The goal is to utilize advancing technology to improve study data accuracy and quality while decreasing the burden of data collection on busy clinical research professionals.

Objectives: This report discusses findings from the SWOG Cancer Research Network's use of a secure and trusted third-party cloud-based application as a technology link between EHR databases and the clinical trial EDC application. The objectives are to ease the burden on site staff and improve data accuracy and completeness.

Methods: Three SWOG sites used a cloud-based EHR-to-EDC application to enter study data for two follow-up tumor assessment case report forms for six patients each. This software-assisted method was compared to manual medical record abstraction. Time savings, error rate, and interrater reliability were measured.

Results: A comparison of the two methods demonstrated substantial time savings and improvements in data quality. This is especially true for data fields that can be automatically captured using the application for clinical trials using the software-assisted approach.

Conclusions: Using a secure and trusted cloud-based application to access the EHR to assist in data collection for clinical trials resulted in welcome time savings for clinical research professionals and higher data accuracy.