Versions Compared

Old Version 1

changes.mady.by.user Matthew Warren

Saved on

compared with

New Version Current

changes.mady.by.user Lorraine Sobson

Saved on

Key

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

Subject Elements describes the actual order of elements that were traversed by the subject, together with the start date or start date and time and end date/time for each. Planned elements are described are described in the Trial Design Model model (see Section 5.1.1,   Trial Arms and Trial Elements). Because actual data does not always follow the plan, the SDTM allows for descriptions of an unplanned element for subjects (SEUPDES).

See the implementation guides for guides referenced in Section 1.2, Implementation Advice for this Model, for further guidance regarding  regarding use of additional identifier and timing variables.

...