Table 5.

Data-Auditing Plan

Data Type	Frequency of Review	Reviewer
Subject accrual (including compliance with protocol enrollment criteria)	Weekly	PI
	Monthly	Study team
Status of all enrolled subjects, as of date of reporting	Weekly	PI
Data-entry quality-control checks	Each visit Per occurrence	PI PI
SAEs (unexpected and related)	Per occurrence	PI
SAEs (expected or unrelated)	Per occurrence	PI
Unanticipated problems	Per policy	IRB

PI = principal investigator (ES); SAE = serious adverse event; IRB = institutional review board.