Development of CDISC Therapeutic Area Standard for Colorectal Cancer - Program Director/Principal Investigator (Last, First, Middle): Kisler, Bron Witt
Development of CDISC Therapeutic Area Standard for Colorectal Cancer
Project Summary
The objective of this project is to develop a global, non-proprietary CDISC data standard for Colorectal
Cancer, utilizing the CDISC standards development process. Colorectal Cancer is the 2nd leading cause of
cancer related deaths in the United States, which carries significant costs for research and treatment. The
CDISC Therapeutic Area Standard for Colorectal Cancer will be used in regulatory submissions as well as data
collection for new clinical trials.
The Specific Aims of this project include:
¿ Work through existing partnerships with FDA and NCI as well as the broader cancer research
community to develop a CDISC Therapeutic Area Standard for Colorectal Cancer using the CDISC
standards development process.
¿ Ensure alignment with the CDISC SDTM standard for electronic regulatory submissions to the FDA.
¿ Through our long-standing partnership with National Cancer Institute (NCI) Enterprise Vocabulary
Services (EVS), provide applicable oncology research concepts and controlled terminology coded in the
NCI EVS terminology system.
¿ Use the CDISC SHARE Metadata Repository and other tools to support development of the Colorectal
Cancer data standard.
¿ Publish a CDISC Therapeutic Area Standard for Colorectal Cancer, making it publicly available through
the CDISC website.
This project will be accomplished through several distinct stages as part of the CDISC therapeutic area
standards development process:
¿ Stage 0 – Initiation and Scoping: Review and approval of project proposal and define scope.
¿ Stage 1 – Identification of Research Concepts: Create multi-disciplinary core team (including FDA
contact), review available prior work, design concept maps, create new concept map templates,
and perform gap analysis with existing CDISC constructs.
¿ Stage 2 – Development of Draft Standards: Core team develops detailed metadata for SHARE in SDTM
format, draft user guide.
¿ Stage 3.1 – Internal Review: Review of draft standards by relevant CDISC teams and experts in
Colorectal Cancer.
¿ Stage 3.2 – Public Review: Review of draft standards by general public for a minimum of 30 days,
approve as a final production standard.
¿ Stage 3.3 – Public Release: Data standard posted to CDISC website.
¿ Use CDISC SHARE Metadata Repository and other electronic tools to maximize the reuse of existing
metadata and controlled terminology.
