Table 3.

Example lost-to-follow-up risk.

Label	Value
Risk Short Name	Lost-to-follow-up
Research Component	10. Endpoint(s)
Risk Description	The secondary endpoint is being collected at 6 months. A high proportion of subjects lost-to-follow-up will limit data available for this analysis.
Initial Risk Category	Heightened
De-Risking Decision	Accept
De-Risking Summary
Final Risk Category	Heightened
Study Conduct Status	Pre-study Conduct
Risk Status	RM
Likelihood	3 Probable
Impact	5 High
Detectability	1 Highly Detectable
Risk Score	15
Key Risk Indicator	KRI: # Completed / # Expected A subject will count in the numerator whenever a follow-up is completed. A subject will count in the denominator (# Expected) as soon as he/she enters the follow-up window (6 months – 2 weeks). Logic: By counting subjects as expected as soon as they enter the window, our follow-up rate will be biased lower. We will take a more conservative approach to follow-up rate monitoring to ensure an adequate rate upon completion. The contingency plans for this risk will not be enacted until we have at least 30 subjects who have entered the follow-up window.
Mitigation Plan	Follow-up rates will be presented on every research coordinator and all-site call. In addition, we will create a report that shows site when a subject is expected to fall in the window. An incentive has been incorporated in the protocol for the subject to encourage follow-up completion. We will also send a text message the day prior to the scheduled follow-up to remind the subject of the phone call.
Threshold(s) & QTL	The following threshold categories have been identified: • Green: [0.9, 1.0] • Yellow: [0.8, 0.9) • Red: [0, 0.8)
Threshold(s) Contingency Plan(s)	Yellow: A report showing follow-up rates by site will be reviewed. Sites with follow-up rates that individually fall in the Red threshold region will have retraining provided. A detailed report will be created for the site that summarizes characteristics of subjects who do not complete the follow-up visit. Red: Sites with follow-up rates falling in the Red threshold region will be put on probationary with 6 months given to increase their follow-up rates. At the end of the 6-month probationary period, if the site is in the red, the site will be dropped and an additional site will be added. Additionally, we will increase incentive amounts for subjects to complete the 6-month follow-up across the study.
QTL Contingency Plan (s)
Responsible Party	Statistician
Measured in DB?	Yes