From The Editor | June 17, 2025

25 Tips To Prepare A Clinical Site For FDA Inspection

By Dan Schell, Chief Editor, Clinical Leader

FDA cleared, drug registration-GettyImages-1509265794

During the past few months, I’ve interviewed four women (see hyperlinks at the end of the article) who have either been a former FDA investigator or been involved with many regulatory inspections. Additionally, last year I interviewed former FDA investigator Vin Cafiso about his “20 Things Never to Say to an FDA Investigator” list, and I spoke with another former FDA inspector, Patrick Stone, about what to expect from an FDA inspection. From all those interviews, I’ve culled the following list of takeaways that I hope you will find useful when preparing for any type of regulatory inspection. And, if I’ve missed any, please send me an email at dan.schell@lifescienceconnect.com.

IMMEDIATE ACTIONS

Notify your CRA/sponsor immediately — This should be your first priority when you learn of an inspection.
Inform your Project Manager and Quality Assurance department — Keep all stakeholders in the loop.
Review the FDA's BIMO inspection guide — The FDA publishes the actual guide their inspectors use. The FDA's BIMO Compliance Program Guidance Manuals are publicly accessible online.

DOCUMENTATION & RECORDS

Ensure all training records are current and complete – This is one of the first things inspectors check.
Update and verify your Delegation of Authority (DOA) — Every task must be assigned to a qualified, trained person.
Keep your CV up to date — Personal documentation should be current.
Maintain complete IRB submissions and approvals in your Trial Master File — Don't rely on portal access during inspection.
Prepare the PI's list of studies — Requirements are in the inspector's manual; have this ready on day 1.
Review and organize all patient data and regulatory files — Conduct a thorough pre-inspection review.
Ensure drug accountability logs are accurate and up to date — This is a common area of focus during audits.

TEAM PREPARATION & COMMUNICATION

Conduct mock interviews with staff — Practice answering sample questions beforehand.
Establish clear team workflow and roles — Designate front room host, minute-taker, and back-room support.
Brief all staff on appropriate communication — Everyone should know when to stop talking and stay composed.
Only answer questions you're qualified to answer — Even if you know the answer, defer if it's outside your role.
Consult site SOPs before discussing procedures — Always reference official documentation.

SYSTEM ACCESS & SECURITY

Revoke access for departed staff members — Ensure all former team members have their system access terminated.
Save correspondence about access revocation — Document all access management actions.
Prepare EDC and platform access records — Have documentation of who accessed what systems and when.
Request IT access early if needed — Don't wait until the last minute for technical requirements.

INSPECTOR RELATIONS & LOGISTICS

Be professional, respectful, and courteous — Attitude can impact the inspection outcome.
Provide a private conference room with refreshments — Offer snacks, coffee, and water.
Give exactly what they ask for, nothing more — Don't volunteer additional information beyond requests.
Have all medical records on-site and ready — Ensure physical availability of required documents.

PROCESS & MINDSET

Self-identify problems and implement CAPAs — Show proactive quality management; inspectors shouldn't be first to find issues.
Expect to find minor issues — Inspectors will find things you didn't imagine; focus on patient safety over perfection.

ADDITIONAL TIPS

Start preparation immediately — Don't save all your inspection-related tasks for the day before inspection.
Document everything in real-time — Don't recreate missing documents after the fact.
Licensed professionals must assess AEs/SAEs — Non-licensed staff performing medical assessments is a major finding.
Inspectors expect some deviations — Perfect records can appear suspicious