Both clinical and study management data

If you create reports with clinical data and study management data, keep the following in mind:

• You can include data from only one clinical form.
• Do not use elements from the following study management report topics in reports that also contain clinical elements:
  • Sections
  • Items
  • Rules
  • Queries
  • Comments

  Report results will be difficult to interpret if you include these report elements.

• For best results, include only one element from the study-specific clinical data model with no more than two elements from the Trial Management data model for each report that includes both clinical and study management data.

Note:

This suggestion does not apply to DOV elements.