top of page


Raw data conversion to CDISC-SDTM tabulated data

SDTM Annotated CRF (SDTM aCRF), based on the CDISC-SDTM Metadata Submission Guidelines

Development of specifications file for the mapping of raw data to SDTM tabulated datasets

Programming of SDTM Datasets based on the specifications file

Quality Control: Pinnacle21, CDISC-SDTM Implementation Guide, comparison (programmatic and manual) review of listings containing raw data vs. SDTM tabulated data

Programming of define.xml metadata file

Study Data Reviewer's Guide (SDRG): based on specifications of the Clinical Study Data Reviewer's Guide (cSDRG) Package (PHUSE)

SDTM/IG Version: The SDTM/IG version for mapping of raw data to SDTM datasets is based on FDA Data Standards Catalog / Submission Data Standards

bottom of page