Activity Plan Review

Activity plan review should focus on validation of schedules of assessments and should include testing of activity plan completeness and functioning, such as:

• Time point completeness

• Cross-form edit checks

• Cross-form methods

• Deviation windows

The assumption at this stage is that functioning of each unique form has already been tested as part of the Unique Form Review cycle. Therefore, this review cycle should not focus on collecting data against each form.

Activity plan review should occur prior to mapping of eligibility criteria.