Assessment and follow-up schedule
Entry or index → baseline → assessments → end of follow-up
Flow diagram
Steps
Entry or index definition
Specify entry or index and its relationship to baseline measurement.
Baseline assessment window
Specify timing, allowed windows and measures collected before or at entry.
Scheduled follow-up assessments
Define nominal visits and tolerances; add repeat periods as needed.
Unscheduled and event-triggered assessments
Define triggers, event capture and handling of out-of-window measurements.
End of treatment or observation
Distinguish treatment discontinuation from end of outcome observation.
Final follow-up and cutoff
Specify study closure, safety follow-up and data cutoff.
Tables and supporting information
Assessment schedule
Use study-defined visits and intervals; blank cells do not mean not required.
Discontinuation and missed visits
Define continued outcome collection and missed assessment handling.