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CDISC-SDTM
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
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