FDA Audit Readiness - ASCO

American Society of Clinical Oncology Research Community Forum Version: September 2019 ASCO Tool ki t: FDA Audi t Re a di nes s 1 TOOLKIT OF RESOURCES FDA Audit Readiness American Society of Clinical Oncology Research Community Forum Version: September 2019 ASCO Tool ki t: FDA Audi t Re a di nes s 2 Page Number Overview 3 FDA Inspections ASCO Research Community Forum At-A-Gl a nc e: FDA Inspections of Clinical Trials 5 Types of FDA Inspections 8 FDA Audi t Pr oc es s 9 Questions to Ask FDA 10 Sa mpl e FDA Form 482 11 Potential Audit Questions for Principal Investigator 12 FDA Inspection Preparation Checklist 15 FDA Inspection Site Summary 33 Si te Summa ry of Inspection 34 FDA Form 483 Do s and Don ts 36 Sa mpl e FDA Form 483 37 Sa mpl e Responses

findings with PI. If warranted, Form 483 issued Investigator responds within 15 days. FDA inspection report issued. Inspection classified by FDA Regional Office. If warranted, warning letter issued PI responds. Potential re-audit. FDA reviews PI response. There are several elements within the FDA audit process for which the investigator and ...

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