All content on this Wiki is non-binding and any individual opinions expressed should not be considered indicative of the policies or positions of CDISC or any other organization.

Page tree

Please do not comment on pages that are not marked as having changed.

Skip to end of metadata
Go to start of metadata

This page is new and created to show the exact revisions for this version.

This appendix lists all revisions since the last production version. 

The changes made from SENDIG v3.1 to SENDIG v3.1.1 are as follows:

  • PC Domain:
    • PCBLFL changed to Perm (was Exp)
    • PCDTC changed to Perm (was Exp)
    • PCELTM changed to Exp (was Perm)
    • PCTPTREF changed to Exp (was Perm)
    • Assumption added to state intended purpose of PC domain
    • Assumptions rewritten to emphasise importance of PCNOMDY, PCELTM and PCTPTREF in plotting concentration profiles
    • All existing examples removed and replaced with Cross-Domain Examples, plus one PC specific example of how best to represent an unscheduled concentration sample
  • PP Domain:
    • Assumption added to describe relationship from PP back to PC
    • All existing examples removed and replaced with Cross-Domain Examples, plus one PP specific example of how best to qualify AUC tests
  • Three Cross-Domain Examples Added
    • Example 1 - EX, PC, PP and SUPPPC showing population of timing variables, when all timing information is readily available electronically
    • Example 2 - PC, PP and SUPPPC showing population of timing variables, when only the minimum amount of timing information is readily available electronically
    • Example 3 - PC, PP, SUPPPC and POOLDEF showing population of timing variables for a sparse sampling study.
  • Dataset Level Metadata
    • Table 3.2.1 Dataset Definition Metadata Example updated for PC to reflect changes to PC domain definition
    • Table 3.2.1 Dataset Definition Metadata Example updated for PP to reflect changes to PP domain definition

  • No labels