Module to generate Define.xml for SDTM and ADaM

Pre-loaded with the CDISC Metadata and Controlled 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