How to Prepare for an Audit: Identify the activities that facilitate preparation for an audit at two time points, before the study is initiated and upon notification of an upcoming audit. Also included is information specific to FDA-governed studies.
What to Do During an Audit: Identify suggested activities for the study staff during the audit.
Request Help Preparing for an Audit: Identify the process for requesting assistance in preparing for an upcoming audit by a sponsor or federal agency of a MCW/FH IRB approved study.