Table 3 Components of the Clinical Impression of Change in Severity© (CI-CS) Assessment
TASK | TIMEPOINT | RESPONSIBLE PERSON(S) |
|---|---|---|
Determine CI-CS Primary Anchor Test (8MWT or 9HPT-D) | Visit 1 | Principal Investigator |
Anchor Tests Video Recordings | Visit 2, 3, 4, 5, 6, 7, 8, 9, 10, Early Termination (as applicable) | Qualified Video-Recorder (Study Team Member) |
CI-S & CI-CS Assessment Anchor Tests | Following Last Visit (Parent Study: Visit 6; Extension Phase: Visit 10) | Blinded Independent Raters |