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Define.xml:
  • Pre-loaded with the CDISC Metadata and Control Terminologies. Create Study/Upload XPT’s & Annotated CRF/Process/View as Define.xml – in minutes.
  • Reverse Engineer Define XML from related studies to extract Study Metadata. Progressively Add XPT’s/Edit Study Metadata/Edit Exception Report and view in Define XML specification format.
  • View and Edit all Exceptions in place in UI View/Edit all levels of the Study Metadata – Domain, Variable, Value, Where Clause, Code list, External Code list, Computation Methods and Reference Docs in place
  • Export the Study Metadata as Excel and Re-Import with changes/corrections Configurable to User requirements.
Reviewers Guide:
  • Pre-defined or Customized template for your Study or Submission data
  • Accurate justifications – noted from Data Issues items
  • Auto adjustment for linking and formatting in a final document