The following rules pertaining to groups/cohorts determine the criteria for completion of non-interventional trials:
- Single-group trials (number of Groups/Cohorts = 1) do not require study group records (on the Groups/Cohorts page) if the trial has either one intervention or no intervention records
- Multi-group trials (number of Groups/Cohorts > 1)
- Require one or more Group/Cohort records (on the Groups/Cohorts page)
- The number of study group records (on the Groups/Cohorts page) must be the same as the number of groups indicated on the Design Details page
- Each intervention must be associated with a group/cohort
