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PharmaSUG 2015 Paper -- Getting Rid of Bloated Data in FDA Submissions

by SAS Employee Frank_sas on ‎04-24-2015 04:20 PM - edited on ‎10-05-2015 03:05 PM by Community Manager (345 Views)

Getting Rid of Bloated Data in FDA Submissions was presented by Ben Bocchicchio on Tuesday, May 19, 2015 at PharmaSUG in Orlando, FL.  The presentation included the following resources and utility programs, which can be downloaded from this article on the SDD Forum.  

 

  1. 1-fdaRules.sas:  code to read FDA SDTM validation rules spreadsheet
  2. OpenCDISC checks
    1. 2a-OpenCDISCComplianceChecks_3-1-3.txt: text file with OpenCDISC SDTM 3.1.3 validation checks
    2. 2b-openCdiscChecks.sas: code to read text file
  3. 3-fda_openCdisc_reconciliation.sas: code to identify FDA validation rules that are covered by the OpenCDISC SDTM 3.1.3 validation checks
  4. reconciliation lists (SDTM 3.1.3)
    1. matched.sas7bdat: list of FDA validation rules and their corresponding OpenCDISC checks
    2. unmatched_fdarules.sas7bdat: list of unmatched FDA Rules
    3. unmatched_opencdiscchecks.sas7bdat: list of unmatched OpenCDISC Checks
  5. 5-checkFolders.sas: utility program to check whether submission folders conform to FDA rules
  6. 6-checkXPTFiles.sas: utility program to check whether transport files conform to FDA rules
  7. 7-checkDataSets.sas: utility program to check whether data sets conform to FDA rules
  8. 8-resizeChars_ReadMe.txt: utility program to resize character variables so that they are the length of their longest value
  9. 9-checkSplits.sas: utility program to check whether splits conform to FDA rules
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