Table 2.

Example gait assessment risk.

Label	Value
Risk Short Name	Inaccurate gait assessment
Research Component	10. Endpoint(s)
Risk Description	There is variability in the way sites perform gait assessments as standard of care. This could lead to a different quantification of the primary outcome.
Initial Risk Category	Critical
De-Risking Decision	Eliminate
De-Risking Summary	The protocol was updated to require a video of the primary outcome be captured. This allows for an independent reviewer to confirm primary outcome calculation
Final Risk Category	Standard
Study Conduct Status	Pre-study Conduct
Risk Status	End