Data Guide Archived Content

From PHUSE Wiki
Jump to: navigation, search

Data Guides, An Analysis

This analysis was submitted by John Brega and Jane Diefenbach of PharmaStat. It is based on methods they have developed through their eCTD submissions consulting practice.

Data Guide Analysis


In addition to the topics covered in this document, Amy Malla has suggested that the following topics be addressed in a Data Guide:

  • Note what important data, if any, is contained in supplemental qualifier datasets
  • If any subjects have no exposure information, explain why they did not receive study treatment
  • List the lab tests with no units
  • Provide explanations for OpenCDISC error and warning messages

Data Guide Examples

Example Data Guide Templates

Data Guide Template provided by Doug Warfield, FDA
Tabulation Data Guide Template provided by Pharmastat
CDISC Metadata Submission Guideline (MSG)


Example Tabulation Data Guides
Tabulation Data Guide Example provided by Industry 1
Tabulation Data Guide Example provided by Pharmastat
Tabulation Data Guide Example 1 provided by CBER
Tabulation Data Guide Example 2 provided by CBER
Additional Tabulation Definitions Example provided by CBER


Example Analysis Guides
Analysis Data Guide Example provided by Pharmastat
Analysis Program Guide provided by Pharmastat