Specific clinical research areas engaged in billing for items and services associated with participation in a clinical research trial may be reviewed periodically. The Office of Research Administration (ORA) will identify the specific areas, investigators and studies to be reviewed. Audits will be conducted as routine, departmental request or special request. If a review identifies issues of non-compliance, ORA will work with the research team, appropriate departmental administration, and appropriate billing entity regarding the issue(s). If necessary, ORA will work with the University General Counsel to determine if there has been any activity inconsistent with university policy. If, at the conclusion of any review, it appears there are compliance concerns, a corrective action plan will be formulated and initiated as quickly as possible.




