Human Research Protection Program

If you are interested in obtaining a review of your regulatory and study subject files in preparation for an upcoming audit by an external party, contact the Quality Improvement staff.

Notification

Whenever possible provide 1-2 weeks advanced notice of pending audit.

Services

Services offered include but may not be limited to the following:

• Identification of beneficial activities in preparation of upcoming audit
• Identification of activities which can be expected during actual audit
• Review of IRB study file
• Review of investigator’s regulatory file and comparison of contents to the IRB study file
• Review of signed informed consent forms
• Review of study subject files/source documentation and comparison to recorded research data
• Review of study logs and tracking forms and comparison to correlating documentation

Benefits

Benefits of review:

• Feedback regarding conduct of study, documentation of study activities, or status of regulatory file
• No charge
• Scope of review can be all-inclusive or limited to a specific aspect of the study such as the regulatory file
• Greater sense of preparedness for upcoming audit

Contact Information