Page History

E2C Co-Leads

Geoff Low and Trisha Simpson

E2C Team

The E2C team maintains its membership through recruitment of volunteer subject matter experts who work together to change clinical research.

Founding Team Members

Sebastian Bostel, Sam Hume, Dave Iberson-Hurst, Chrissy Johnson, Geoff Low, Jennifer Price, Mitra Rocca, Trisha Simpson, and Gary Walker.

Team Mission

To develop and maintain the appropriate tools (e.g., data mappings) needed to enable efficient data transfer between healthcare and clinical trial systems.  

Scope

The E2C team develops data mappings for clinical research that:

• Address the needs of multiple stakeholders;
• Allows for direct use of eSource;
• Permit optimal data entry for site staff;
• Maintain transparency from data capture to data reporting.

History

E2C was formed in 2014 to develop data mappings from the Continuity of Care Document (CCD) to CDASH. After completing the mappings for Demography, Concomitant Medications, Medical History, and Vital Signs, the team went hiatus in 2015. The team was re-formed in 2017 to continue work on the data mappings.

Current Focus

The team will complete a core set of data mappings from the CCD to CDASH and work on the FHIR to CDASH mappings.

Stakeholders & Constituencies

• Academic Researchers
• Biotechnology
• Biopharmaceutical & Pharmaceutical Sponsors
• Contract Research Organizations & Consultants
• Medical Devices, Diagnostics
• EHR vendors
• Regulatory Authorities
• Clinical Research Sites
• Standards Development Organizations
• TransCelerate Biopharma
• PhUSE
  
  

Collaborations

E2C works closely with the CDISC CDASH team, HL7, PhUSE, EHR vendors and others in the healthcare arena to ensure the

Operation Model & Meetings

• The team meets every other Thursday.
• Ad hoc meetings are scheduled as needed.