E2C Team Charter

CDASH Co-Leads

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.

CDASH Governance Committee (CGC)

Melissa Binz, Judy Tran, Kit Howard, Gary Walker, Shannon Labout, Michael Ward, Lorraine Spencer,

CDASH Team

The CDASH team maintains its membership through recruitment of volunteer subject matter experts who can contribute to its various sub-teams with technical and/or therapeutic-based knowledge.

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.

Scope

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

• Address the needs of multiple stakeholders;
• 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 2012.

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 requirements.

Stakeholders & Constituencies

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

Collaborations

CDASH 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.

Operation Model & Meetings

• The CELT meets on the third Monday of every month.
• CDASH “All Hands” meets each quarter. 
• The CGC meets every two weeks. 
• The individual sub-teams leads determine the frequency of the sub-teams meetings.