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  • SDTM datasets of clinical data and measurements for selected cancer collections to TCIA (DI-Cubed-Reports)

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A subset of the standardized data was then exported from I2B2 in SDTM compliant SAS transport files.  The SDTM data was derived from data taken from both the curated TCIA spreadsheets as well as tumor measurements and dates from the TCIA Restful API.  Due to the nature of the available data not all SDTM conformance rules were applicable or adhered to.

These Study Data Tabulation Model format (SDTM) datasets were validated using Pinnacle 21 CDISC validation software. The validation software reviews datasets according to their degree of conformance to rules developed for the purposes of FDA submissions of electronic data.  Iterative refinements were made to the datasets based upon group discussions and feedback from the validation tool.

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  • DM (Demographics)
  • DS (Disposition)
  • MI (Microscopic Findings)
  • PR (Procedures)
  • SS (Subject Status)
  • TU (Tumor/Lesion Identification)
  • TR (Tumor/Lesion Results)

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