Versions Compared

Old Version 2

changes.mady.by.user Anthony Chow

Saved on

compared with

New Version 3

changes.mady.by.user Anthony Chow

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

Let's start with an anatomy of metadata: A CDISC SDTM domain or ADaM dataset includes variables. A variable is either represented by a CDISC Controlled Terminology codelist or by a value format. For example, ADaM ADAE (adverse event analysis dataset) includes AESEV (Severity/Intensity) variable, which is represented by the AESEV (CDISC SDTM Severity Intensity Scale for Adverse Event Terminology) codelist.[1] This AESEV codelist has 3 permissible values, MILD, MODERATE, SEVERE, with specific meaning.[2]

This ISO 11179 metamodel region[3] can be used to generalize these metadata components:

...