List of Studies and Standards Nonclinical Study Study Start Exchange Terminology Identifier Brief Title Study Type Study Status Date Standards Standards If value is Please See Completion COMPLETED ccyy-mm-dd LEGACY Sponsor Defined unknown, Guidelines for more <(forecasted Terminology ONGOING SDTM v<version>/ specify TBD information Protocol sign)> SEND IG <version> CDISC SEND PLANNED If value is unknown, leave Terminology TBD SDTM vTBD/ blank or specify TBD <date> SEND IG TBD <TBD> tumor.xpt NONE define.xml<version> define.xml TBD No Electronic Data Clinical Study Study Start Exchange Terminology Brief Title Identifier Study Design Study Status Date Standards Standards <Phase <x>> <Interventional/Observational/Expanded Access> Studies - <indication or Healthy Subjects or Healthy Volunteers>
List of Studies and Standards Nonclinical Study Identifier Brief Title Study Type Study Status Study Start Date Exchange Standards Terminology Standards If value is unknown, specify TBD Please See Completion Guidelines for more information If value is unknown, leave blank or specify TBD COMPLETED ONGOING PLANNED ccyy-mm-dd <(forecasted Protocol sign)> TBD LEGACY SDTM v<version>/ SEND IG <version> SDTM vTBD/ SEND IG TBD tumor.xpt define.xml<version> define.xml TBD No Electronic Data Sponsor Defined Terminology CDISC SEND Terminology <date> <TBD> NONE Clinical Study Identifier Brief Title Study Design Study Status Study Start Date Exchange Standards Terminology Standards <Phase <x>> <Interventional/Observational/Expanded Access> Studies - <indication or Healthy Subjects or Healthy Volunteers>
phuse-tp001-study-data-standardization-plan-v1-8409.docx