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This content was written exclusively for the BDC
by Emily Fivekiller, MPH, CCRP
Assume any study overseen by the FDA has the potential to be audited
Comprehensive, agency-wide program of on-site inspections and data reviews designed to monitor all aspects of the conduct and reporting of FDA-regulated research
BIMO Objectives
Know FDA BIMO Metrics
https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/bimo-inspection-metrics
Inspections Operation Manual
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/investigations-operations-manual
Chapter 5 covers site inspections
Failure to Follow Protocol
Inadequate Records
Training
Case History
Study Records
Failure to Protect Subjects
Informed Consent Issues
Safety Reporting
Screening
Inclusion/Exclusion and Subject Enrollment
Tools
Preparation
SOPs Available
Typically Via Phone, Usually w/in 5 days of intended start
Clinical Trial Agreements & Financial Disclosures
Epic Access
Calls are Courtesy and Not Required
Key Study Dates, Enrollment timelines
IRB Approvals
Recorder - Uninvolved with the Study Under Inspection
Attempt to Accomodate Their Schedule
Determine Who Will Interact With the Inspector, Contact Should be Minimized
Consents and AEs / SAEs, Protocol Deviations and Notes or Memos to File
Keep a Record of All Documents Requested, and A Duplicate File For Your Records
1
List of all studies PI has been involved in as a PI or Sub-I over the last 5 years
Organizational Charts:
BDC & Team Specific
2
3
Detailed Study Timeline
Inspectors May Ask For A Variety of Study Documents to:
Verify Protocol Compliance
Compare Source and Submitted CRFs
Review Device and Drug Accountability Records
Review Other Study Related Documents
Review Medical Records to Ensure AE/SAE Reporting
Request a Closure Meeting
Clarify Any Confusing Remarks and Determine Next Steps
Potential Outcomes
No Action Indicated
Voluntary Action Indicated
Official Action Indicated
Hear Inspector Observations
No Action Indicated: There were no findings and no response is indicated
Voluntary Action Indicated: Some objectionable conditions but not at threshold to take action
For either of these a formal response is not required. Consider any notes or corrective actions and policies that you can implement in future studies
A Written Response in the Form of A Corrective Action, Preventative Action (CAPA) Plan Should be Prepared
This depends on the sponsor, for some studies we have had sponsors come out and do a pre-study internal audit
For our most recent they did not come out but were available via email in case we needed a copy of anything but were mostly there to receive report on how the audit was going
Gather your team and initiate a plan of action
Retrieve binders - Iron Mountain / Storage
Review Critical Data - Complete Study Timeline
Review:
Consents
AEs/SAEs
Inclusion/Exclusion Criteria
Visit CRFs
Consents
AEs/SAEs
IRB documents
Trainings/Certifications/CVs
Device/Drug Accountability
Calibration logs
DOA log
Screening and Enrollment Log
Know your protocol
Be aware of all AEs/SAEs that occurred, when/how they were reported and be able to speak to these
Review your consents and be able to speak to any discrepancies or deviations.
Create a detailed study timeline - I can share an example if this is helpful
Keep an evolving record of Investigator trial involvement - this is easier to do ongoing as opposed to retrospective.
Becoming overwhelmed. The best thing you can do is remain calm and institute a plan for how to review the documents before inspectors come.
Sometimes there are many patient and regulatory binders, focus on the items discussed that are commonly reviewed by inspectors, then if there's time, proceed to other less critical study portions.
Know FDA BIMO Metrics
https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/bimo-inspection-metrics
Inspections Operation Manual
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/investigations-operations-manual
Chapter 5 covers site inspections
The 483 is not a final determination, but is a notice that the inspector found pieces of the audit objectionable and require a written CAPA w/in 15 days. This is then reviewed by the FDA and a determination is made
FDA 483 FAQs available here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/fda-form-483-frequently-asked-questions
Unfortunately this is a common cause for a 483.
Best practice is know whats missing and be able to answer with a clear and concise 'why' should the investigator ask
For former workers, there is not much to be done either. You can see if they may have another similar training in your files that could be used: i.e. skillsoft in place of CITI or a study specific training