Versions Compared

Key

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

The timing of collected collection of observations is generally planned,

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-635
but observations may also be collected outside a planned schedule. Additionally, the actual timing of observations is collected. Guidance in this section describes the expected population of variables to represent the planned. unplanned, and actual timing of observations.  When guidance is applicable only to TIG Nonclinical or Product Impact on Individual Health use cases, this is denoted in the Implementation column,

...