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CDASH CoE2C Co-Leads

Geoff Low and Trisha Simpson and Lorraine Spencer

CDASH Extended Leadership Team (CELT)

The CDASH Sub-team Leads and CDASH Coalition For Accelerating Standards & Therapies (CFAST) Therapeutic Area (TA) Standards Leads form the Extended Leadership Team. The CELT meets on a monthly basis in order to address cross-team issues,share relevant information, and ensure efficient resource utilization.

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

CDASH Education

The CDASH training team works cooperatively with CDISC Education to develop course materials, identify and qualify new instructors, and deliver authoritative training on the CDASH standard through classroom and online courses.

Team Mission

To develop and maintain data acquisition standards and user guides that allow for the efficient recording, exchange, analysis, submission, and archiving of clinical research and metadata.maintain the appropriate tools (e.g., data mappings) needed to enable efficient data transfer between healthcare and clinical trial systems.  

Scope

The CDASH E2C team develops data acquisition standards mappings for clinical research that:

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

History

CDASH was formed in 2006 as a collaborative effort between CDISC and the Association of Clinical Research Organizations (ACRO) to specifically address FDA’s Critical Path Initiative Opportunity #45, Consensus on Standards for Case Report Forms. The first version of the basic content standards was published in 2008. Subsequently, the team released version 1-1.1 of the CDASH User Guide (available as ODM forms) in April 2012E2C 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 continue to update the CDASH Standard (i.e., the Model and User Guide) and education materials in order to support revisions to other CDISC standards; incorporate new domains and variables resulting from the CFAST TA development; and address new regulatory requirementscomplete 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
• CFAST TA Teams
• Contract Research Organizations & Consultants
• Medical Devices, Diagnostics
• EHR vendors
• Regulatory Authorities
• Clinical Research Sites
• Standards Development Organizations
• TransCelerate Biopharma
• PhUSE
  
  

Collaborations

CDASH works E2C works closely with all of the CDISC foundational standards teams, CFAST teams, NCI-EVS, and other industry groups in order to ensure the CDASH Standard provides the highest quality and most current data capture guidance available. The CDASH team includes representatives from all facets of the clinical trial industry in order to ensure the CDASH Standard is easily adoptable and usable by all parties.the CDISC CDASH team, HL7, PhUSE, EHR vendors and others in the healthcare arena to ensure the

Operation Model & Meetings

• The CELT team meets on the third Monday of every month.
• CDASH “All Hands” meets each quarter. 
• The CGC meets every two weeks. 
• every other Thursday.
• Ad hoc meetings are scheduled as neededThe individual sub-teams leads determine the frequency of the sub-teams meetings.