Expected RFI Audit Questions

Expected CPU Audit Questions General Capabilities Length of existence of the CPU? Any recent mergers? If yes, name of previous facility? Is the Investigator / CPU restricted or debarred by the FDA? Has the FDA audited the CPU? Has Sponsor Compliance Dept. audited the CPU? Number of studies per year? Planned? Number of competing studies? Specific Capabilities Does CPU perform PK studies? If yes, what types (FTIH, food effect, etc.) Does CPU perform PD/biomarker studies? If yes, what are the end points? Does CPU perform Radiolabel / ADME studies? Does the CPU do “first-in-man” studies? Close to ICU facility? Does the CPU do ICU type monitored studies What populations has the CPU studied (e.g., healthy volunteers, renal, hepatic, elderly) Is there an active database? (If yes, number/subject type, how often updated?) For food effect studies, does the CPU have capability for food preparation? If not, where handled? Can special diets be prepared? Does the CPU recruit through advertisement? Local paper? Radio? TV? Is CPU set-up for telemetry? Is the CPU accessible to emergency services? How far away is the nearest Hospital with emergency capabilities? Have they used Hospital services? If yes, what was the experience? Is the Emergency Medical System clearly established Physical Description of the Unit Is the CPU appropriate for ambulatory / outpatient studies? Is the CPU appropriate for confined / inpatient studies? Is the CPU appropriate for ...