Therapeutic Area Data Standard for Clostridium Difficile associated Diarrhea

Critical Path Institute, Tucson AZ

Investigators

Linked publications & trials

Abstract

Project Summary: Therapeutic Area Data Standard for Treatment of CDAD The FDA CDER Data Standards Strategy calls for the development, implementation, and maintenance of comprehensive clinical data standards to facilitate the efficient and effective review of regulatory submissions. In response to the FDA's Center for Drug Evaluation and Research (CDER) statement of need to further standardize study data terminologies and concepts for efficacy analysis, and their prioritized list of disease and therapeutic areas (TAs) for which additional data standardization is needed, this project has three specific aims: 1) Development of a Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) User Guide for treatment of clostridium difficile associated diarrhea (CDAD). This User Guide will provide a common language for CDAD data submissions and cover representation of CDAD-specific medical concepts. This User Guide will be developed using the CDISC TA Standards Development Process, and will be published as a document available to all organizations that use and implement CDISC data standards for submissions to the FDA. 2) Development of CDISC-Controlled Terminology needed for the implementation and application of CDISC SDTM data standards for Treatment of CDAD. 3) Development and submission to the FDA of a TA specification to assist the FDA in assessing which SDTM content from the data standard can be included in the FDA Study Data Technical Conformance Guide (TCG). TA specifications describe in a succinct manner how domains and variables used in the TA standard relate to different versions of the FDA-recognized SDTM Implementation Guide (SDTMIG). Aims 1) and 2) are necessary scientific content needed to develop the TA specification for treatment of CDAD.