The EHR-EDC duplicate data entry challenge
Implementation of the manual process for replicating EHR data into EDC involves cost, resource, and collaboration challenges between health systems and sponsors. The expert resource time and significant cost spent on data entry and duplication would be better invested in better quality research. Turnover or shortages in research personnel exacerbate the complexity of this operation and risks to study execution. Manual processes are prone to data inaccuracies which further introduce the need for quality checks and additional time. Insufficient and inadequate data hampers the quality of research and causes relationship difficulties between health systems and sponsors. Health Systems are under increased pressure to deliver surveillance information, yet various sponsors have brought heterogeneous technologies and processes that are difficult to adopt given the very limited resources available to support research.
The solution is CLEHR - CLinical from EHR study integration
CLEHR is an honest broker SaaS offering from Graticule to extract and transmit de-identified data for clinical research studies sourced using the FHIR interface standard. CLEHR brings an innovative easy to implement interoperability solution that minimizes the complexity of data extraction, saving time and money by enabling automated data transfer from EHR to EDC formats.
Structured data is transmitted from the hospital EHR system in a compliant fashion as de-identified data. With this approach, CLEHR can help you get the manual effort down to 30% while the other 70% of data fields are automatically and securely transferred from EHR to EDC.
CLEHR improves connectivity by connecting to over 60 EHRs (and growing) such as Epic, Cerner, and eClinicalWorks using a controlled process to confirm patient identities that meet research protocol criteria. All information is maintained through Graticule as an honest broker maintaining BAAs and a HIPAA secure system allowing health systems and sponsors to collaborate efficiently. Graticule is a digital CRO with multiple solutions for RWD integration.
Benefits of CLEHR
 Saves Time & Costs |     | Elimination of manual duplicate data entry reduces the overall labor costs Eliminates effort in addressing errors as the process is automated and offers automated QC Reduced time in monitoring and responding to queries Reduces the burden of installing infrastructure and establishing agreements for every study depending on sponsor requirements |
 Better Quality Research |     | Increases the ability to collect clinical research data more accurately and effectively Automation provides more data for research and traceability Early identification of errors through automated quality checks Manual resources are freed up to focus on the most important abstraction tasks |
You can find CLEHR in the Connection Hub on Epic Showroom. Epic is a registered trademark of Epic Systems Corporation.
New happenings from Graticule
Dan presented CLEHR at the SCDM (Society of Clinical Data Managers) 2024 Conference. Click here to read his reflections on the show.
