Development of a CDISC Therapeutic Area Standard for Lung Cancer

首席研究员（最后，第一，中）：Kisler, Bron Witt

Principal Investigator (Last, First, Middle): Kisler, Bron Witt Development of Oncology – Lung Cancer Data Standard Project Summary The objective of this project is to develop a global, non-proprietary data standard for Lung Cancer, utilizing the CDISC standards development process and the CDISC SHARE Metadata Repository. This project will lead to the development of specifications for that Therapeutic Area, which capture how to structure commonly collected data and outcome measurements in disease clinical trials. The Specific Aims of this project are:  Develop data standards for Lung Cancer clinical research studies using the CDISC standards development process.  Ensure alignment with the CDISC Study Data Tabulation Model (SDTM) for FDA electronic submissions  Code applicable oncology Concepts and controlled terminology in the NCI EVS terminology system  Use the CDISC SHARE Metadata Repository and other tools to support development of the Lung Cancer data standard.  Publish a Therapeutic Area Standard for Lung Cancer and make it publicly available via the CDISC Website. This project will be accomplished through several distinct stages in conjunction with major enhancements to the standards development process:  Stage 0 – Initiation and Scoping: Review and approval of project proposal and define scope.  Stage 1 – Identification a n d m o d e l i n g of CDISC 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. Education Content is developed in conjunction with Standards Development experts.  Stage 3a – Internal Review: Review of draft standards by relevant CDISC teams and experts in Lung Cancer.  Stage 3b – Public Review: Review of draft standards by general public for a minimum of 30 days, approve as a final production standard.  Stage 3c – Public Release: Data standard posted to CDISC website.  Develop Educational content specific for the Lung Cancer Standard oncology domains to educate users.  Throughout all stages, work with the SHARE team to determine tools to efficiently develop therapeutic area standards and improve availability of metadata in electronic format.