Table 1:

Frequency and personnel for trial conduct auditing

Data type	Frequency of review	Reviewer
Subject accrual (including compliance with protocol enrollment criteria)	Quarterly	PI, Independent Monitor
Status of all enrolled subjects, as of date of reporting	Quarterly	PI, Independent Monitor
Clinical Endpoints/Outcomes Data	Quarterly	PI, Independent Monitor
Laboratory Endpoints	Quarterly	PI, Independent Monitor
AEs and rates	Quarterly	PI, Independent Monitor
SAEs	Per occurrence	PI, Independent Monitor, NIH