CDISC-Mapper

FDA issued a Guidance on Standardized Study Data for Regulatory Submission in December 2014 and required that sponsors must conform to standards in the FDA Data Standards Catalog for NDA, BLA, ANDA studies that started after December 17, 2016. CIDSC standard SDTM (for raw data) and ADaM (for analysis data) are currently acceptable standard by FDA.

The CDISC-Mapper enable you to map the Operational Data Model (ODM) to near SDTM and/or ADaM datasets within CIMS. Once mapping is done, you can extract SDTM datasets anytime during the study. Unlike mapping using SAS, the build-in CIDSC-Mapper creates the traceability of mapped data and source data.