CDASH Extended Leadership Team (CELT)
The CELT is comprised of the CDASH Sub-team Leads and the Therapeutic Area (TA) Standards Leads. The CELT meets on a monthly basis in order to address cross-team issues,share relevant information, and ensure efficient resource utilization.
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.
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. This team is comprised of CDASH members who are authorized CDISC trainers.
To develop and maintain data acquisition standards, therapeutic area user guides and an implementation guide to enable the efficient and standardized recording, exchange, analysis, submission, and archiving of clinical research data and metadata.
The CDASH team develops data acquisition standards for clinical research that:
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. Subsequently, CDASHIG v2.0 and CDASH Model v1.0 were released in September 2017, including the publication of its metadata in SHARE.
The team will continue to update the CDASH Implementation Guide, CDASH Model and education materials in order to support revisions to other CDISC standards; incorporate new domains and variables resulting from the Therapeutic Area User Guide development; and address new regulatory requirements.
Stakeholders & Constituencies
CDASH works closely with all of the CDISC foundational standards teams, Therapeutic Area User Guide 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 Model and CDASH Implementation Guide are easily adoptable and usable by all parties.
Operation Model & Meetings