Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Comment: reformatting

Three variables have been added to the following section. Both of these are restricted in use, as noted in the Usage Restrictions column.

Many variable labels, notes, definitions, or examples were revised. In most cases, these revisions were to use the phrase 'treatment or product' for the case when product use is not considered a treatment. The type of revisions made are described in the tables below:

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keySDTM-711

Section 3.1.1 The Interventions Observation Class





Revisions made

Variable

New

Modified

Removed

Label

NotesDefinition

--TRT


X
XXX
--RSDISC


XXX
--DOSFRM




X

--DOSFRQ






X

--DOSTOT






X

--DOSRGM






X








GNTXAID


X











Section 3.1.2 The Events Observation Class

...

Section 3.1.3 The Findings Observation Class


Revisions made

Variable

Label

NotesDefinitionExamples

--SPEC

X
XX


Two variables have been added to the following section. Both of these are restricted in use, as noted in the Usage Restrictions column.

The following new section was added:

...