There are several resources and services that the Office for Research can provide to investigators who have an upcoming FDA inspection. If an investigator has learned that an FDA Inspection in imminent or has received notice from the FDA that an inspection will occur, the investigator should notify the following departments: Research Regulations Specialist in the Office for Research Office of Research Administration Institutional Official Office of General Counsel Institutional Review Board Department Chair
The Research Regulations Specialist can provide assistance in preparing for the FDA inspection by: - Inspecting the PI's regulatory binders to ensure that all pertinent documents are present and updated
- Cross checking the regulatory binders with the IRB study file to make sure the binder is consistent with materials in the IRB file
- Providing an overview of the FDA process and what to expect
- Being present and providing consultation during an FDA inspection
- Helping the Principal Investigator draft a 483 response letter
Below are some tools to prepare for the audit: The following checklist may be useful in preparing for a FDA inspection: FDA site Checklist In addition, Investigators are encouraged to conduct a self-audit with the aid of the Investigator Self-Assessment that is provided online at: http://www.jhsph.edu/GER/ISAP.doc The Research Regulations Specialist is available to provide assistance with the Self-Assessment tool. The following are web resources for FDA audits: An FDA Audit: What an Investigator Needs to Know - http://www.asgt.org/member_resources/recent_course_materials/training_course/salewski.ppt Information Sheet Guidance for IRB, Clinical Investigators, and Sponsors: FDA Inspections of Clinical Investigators - http://www.fda.gov/oc/ohrt/irbs/investigator.pdf Guidance and Information Sheets on Good Clinical Practice in FDA-Regulated Clinical Trials - http://www.fda.gov/oc/gcp/guidance.html Audit Preparation Suggestions and Strategies - http://irb.jhmi.edu/Guidelines/june2006_monitorsession.ppt The FDA Inspector Cometh: Inspector Process for Clinical Trials - http://www.wlap.org/wl-repository/umich/cacr/cre/20030915/real/sld001.htm | 
