TIPS: Preparing for an FDA inspection Dr A Venkateswaran and Dr Khosla et al offer their advice... The Investigator should identify: Who will serve as escort to the FDA Inspector(s) and who will take notes during the inspection  Who has authority to speak for the site (FDA liaison) How will access to records be handled Who will make copies for FDA (including one copy for Sponsor/ CRO) How will FDA’s requests to interview staff be managed Daily debriefing (time and attendees) Points of FDA access and anticipate FDA’s requirements Rooms to use as a base for FDA (free of unrelated documents in plain sight) Quiet and adequate work area for the FDA inspector(s) Access to phone, fax, power outlets, rest rooms The medical charts of all subjects (screened, randomized, and enrolled) The Clinical Investigator should also: Attend the introductory meeting after receiving the FDA Form 482 (notice of inspection) Be available throughout the inspection to answer questions Be available during daily debriefings Should attend the exit discussion and receive the FDA-483 (if issued) A list of all employees questioned by the FDA Auditor should be maintained as well as questions asked by the Investigator(s) and the answers to the Investigator An extract from 'An FDA Inspector Calls: How to Prepare for an Inspection at Clinical Investigation Sites'