Ever since the US FDA introduced Meaningful Use requirements calling for medical practices to begin using EHR systems, the race was on to find a way to pull the data from EHR systems into the EDC systems electronically. Many options have been tried − most focused on accessing the data from the EHR in the native HL7 format. While this solution works, it's not easy to do. One of the stumbling blocks is the inability of site personnel to access this type of data from their EHR.
Eager to find a solution, our Express EDC team rolled up its sleeves to work on the CDISC initiative.
Mapping EHR CCD Document to CDASH CRFs
Bioclinica joined the E2C team CDISC formed in May 2015, tasked with mapping the information from the EHR's CCD document to CDASH CRFs. CDASH (Clinical Data Acquisition Standards Harmonization) is a standard used to collect patient-based clinical research data. The data collected in this standard is similar to, and can be easily transcribed to the CDISC SDTM (Study Data Tabulation Model) standard required for Submissions to the FDA.
As part of Stage 2 of the Meaningful Use initiative, the health provider must be able to create a summary, or Continuity of Care Document (CCD), from their EHR system. This document may then be retained by the provider and/or be transmitted to a referring practice. The patient's complete medical information may be provided to another healthcare provider in time of need.
Among the data contained in the CCD document are medical history, current conditions, medications and treatment plan. Having this medical information at the physician's fingertips in a time of emergency, or when there is a severe injury or illness rendering a patient unable to speak, can be life-saving.
Express EDC achieves E2C Standard!
I'm happy to report as a result of the team's work, I had the pleasure of demonstrating success of the EHR to CDASH standard (E2C)! Using our Express EDC system as a demonstration platform, we unveiled the successful E2C pilot at the 2015 CDISC International Interchange held in Chicago in November.
The pilot showed we can indeed replace the current method where clinical sites must manually enter patient data into the clinical EDC system – data that is already in the EHR.
E2C eliminates both redundancy and the manual transcription step – and along with it – the potential to introduce data errors and omissions. One more great thing…this pilot also demonstrated an E2C solution that maintains Good Clinical Practice guidelines!
The process to read this patient data into BioClinica Express EDC system is simple, as depicted below.
The user navigates to the relevant data collection form in Express. Simply press the EHR Data button and the correct data is populated in the form as shown below.
Alignment with FDA Guidance
More good news! The demonstrated E2C aligns with Guidance for Industry on Electronic Source Data in Clinical Investigations released in September 2013. The agency's position is:
- Eliminate unnecessary duplication of data
- Reduce the possibility of transcription errors
- Encourage entering source data during the subject's visit where appropriate
- Eliminate transcription of source data prior to entry into a CRF
- Facilitate remote monitoring of data
- Promote real-time access for data review
- Facilitate the collection of accurate and complete data
Section A.2.d of the FDA Guidance entitled ‘Direct Transmission of Data from the Electronic Health Record to the eCRF' states, "Data elements originating in an EHR can be transmitted directly into the eCRF automatically."
This is all done while adhering to FDA requirements to:
- Maintain the confidentiality of the patient
- Identify the originator of the data element
- Allow for modifications or corrections of the eCRF data
- Comply with the Electronic Signature per 21CFR part 11
Learn more, see our E2C demo!
For more information about this and other exciting CDISC initiatives and outcomes demonstrated during the International Exchange, please visit the CDISC website.
For your personal E2C demonstration, reach out to me at Jennifer.Price@Bioclinica.com. I'd be glad to run you through the demo. I'm passionate about the use of standards for the betterment of our entire research and medical community, and would love to hear from you!