Versions Compared

Key

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

...

  • The timing of collected observations (e.g., all vital signs measurements will be represented in domain Vital Signs (VS) irrespective of when measurements occurred).
  • How collected data are used (e.g., all vital signs measurements will be represented in domain VS and a custom domain "safety" domain will not be created for measurements used to assess safety).
  • Data collection methodology (e.g., all vital signs measurements will be represented in domain VS irrespective of whether measurements were recorded using separate CRFs).

...