DataDefine

DataDefine is a user-friendly software application to generate CDISC compliant Define.xml file for regulatory submissions.

Key Features

• • Interactive/GUI based

  • No SAS/XML programming knowledge required

  • Options to maintain standards at CDISC, Sponsor and Project/Study level

  • All Define.XML hyperlinking done automatically

  • Can produce Define.XML for SDTM, ADaM and SEND data

  • If the data provided is SAS datasets, then the tool automatically detects and converts them into FDA compliant SAS XPT files

  • Creates user-friendly pre-filled Excel metadata (spec) template with the study metadata which in turn needs a minimal/no input from the user

  • The pre-filled Study metadata Excel spec file is completely portable

  • Provides a user-friendly GUI option to enter the value level metadata information

  • Get standard comments, computations for standard variables from user-provided datasets avoiding manual entry

  • Automatically creates/assigns data-driven standard controlled terminology in the define.XML

  • Automatically determines and handles split dataset processing and presentation in the define.XML

  • Automatically reads annotated CRF for page numbers. No manual entry needed

  • Save and retrieve the selections

CRFannotator

This module is designed to help the user reduce the manual effort of creating PDF annotations. The module is generic and can be used anywhere annotations have to be done. The specific area where this module helps is for the database annotations, and SDTM annotated CRF.

DataCompare

This utility module helps to compare 2 excel specs/metadata templates.

DataMap

This module helps the sponsor convert the raw data into SDTM standards.

DataCheck

This module helps the sponsor check their data for CDISC standards conformance.