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FDA Inspections of Investigator Sites . Paul Below Clinical Research Consultant P. Below Consulting, Inc. Learning Objectives. Describe the FDA’s Bioresearch Monitoring Program (BIMO) Define the BIMO inspection activities during an investigator inspection

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fda inspections of investigator sites
MAGI\'s Clinical Trial Agreements, Budgets & Regulatory Conference

FDA Inspections of Investigator Sites

Paul Below

Clinical Research Consultant

P. Below Consulting, Inc.

learning objectives
Learning Objectives
  • Describe the FDA’s Bioresearch Monitoring Program (BIMO)
  • Define the BIMO inspection activities during an investigator inspection
  • Describe how inspections are classified
  • Identify resources available on the FDA website to obtain inspection findings

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bimo program overview
BIMO Program Overview

Established in 1977 and expanded in 1992

Comprehensive program of on-site inspections and data audits to monitor all aspects of the conduct and reporting of FDA regulated research

Each FDA Center has its own BIMO program staff with overall coordination by the Office of Regulatory Affairs

Implemented domestically and internationally resulting in over 1000 inspections annually

MAGI’s Clinical Trial Agreements, Budgets & Regulatory Conference

who is inspected
Who is Inspected?

Clinical Investigators

Sponsors/Monitors/CROs

Institutional Review Boards

Non-Clinical Labs (aka GLP)

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inspections by fda center 2006
Inspections by FDA Center (2006)

Source: Compiled from BIMO presentations and statistics on the FDA website

MAGI’s Clinical Trial Agreements, Budgets & Regulatory Conference

inspection triggers
Inspection Triggers

Marketing application submission (majority)

Novel technology

Vulnerable population

“Investigator-oriented” or “For cause” inspections usually done when suspicion of integrity or human subject protection issue (often on-going studies)

Complaints

MAGI’s Clinical Trial Agreements, Budgets & Regulatory Conference

investigator inspections preliminaries
Investigator Inspections – Preliminaries

Assigned by HQ BIMO staff

FDA field inspectors from 19 district offices conduct inspections. They do all kinds of inspections (i.e., GCP, manufacturing, lab)

For routine “study-oriented” inspections, scheduled with site within 2 weeks

Inspectors show credentials (photo ID) and “Notice of Inspection” form (FDA Form 482)

Permission or authorization to inspect of investigator sites is not required. FD&C Act provides criminal penalties for refusal to permit inspections

MAGI’s Clinical Trial Agreements, Budgets & Regulatory Conference

investigator inspections on site activities
Investigator Inspections – On-Site Activities

Inspection Areas:

Protocol compliance

Informed consent

Facilities

Test article accountability

Data audit

Regulatory document review

Detailed procedures for inspections contained in Compliance Program Guidance Manual for Clinical Investigators (7348.811) http://www.fda.gov/ora/compliance_ref/bimo/

MAGI’s Clinical Trial Agreements, Budgets & Regulatory Conference

investigator inspections completion
Investigator Inspections – Completion

End inspection with an exit interview with the investigator

Findings of non-compliance are reported on an FDA Form 483

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most common investigator deficiencies
Most Common Investigator Deficiencies

Failure to follow the investigational plan

Protocol deviations

Inadequate recordkeeping

Inadequate accountability for the investigational product

Inadequate subject protection – including informed consent issues

MAGI’s Clinical Trial Agreements, Budgets & Regulatory Conference

inspection follow up process
Inspection Follow-up Process

After inspection, FDA field inspector writes an establishment inspection report (EIR)

After district office review, the completed EIR package is sent to the FDA

Once the EIR is received, it is assessed and classified by FDA

MAGI’s Clinical Trial Agreements, Budgets & Regulatory Conference

inspection classifications
Inspection Classifications

No Action Indicated (NAI) = the FDA field inspector did not identify objectionable practices or identified only minor issues that did not justify further action

Voluntary Action Indicated (VAI) = indicates that objectionable practices were uncovered during the inspection, but were not significant

Official Action Indicated (OAI) = inspection uncovered significant objectionable practices, which could affect data reliability or compromise human subject protection. Generally results in the issuance of a Warning Letter or some other higher-level compliance action

MAGI’s Clinical Trial Agreements, Budgets & Regulatory Conference

investigator inspection classification 2006
Investigator Inspection Classification 2006

4%

51%

44%

All Centers (n = 595)

Source: “FDA Regulation of Pharmaceuticals and Devices” FDA presentation by Jean Toth-Allen, June 2007

MAGI’s Clinical Trial Agreements, Budgets & Regulatory Conference

inspection classifications1
Inspection Classifications

Long-term OAI rates:

CDRH = 13%

CDER = 3%

In general, OAI classification results in issuance of a warning letter about ~70% of the time

Investigator warning letters issued in 2007:

CDRH = 16

CDER = 6

CBER = 2

MAGI’s Clinical Trial Agreements, Budgets & Regulatory Conference

cder investigator oriented inspections
CDER “Investigator-Oriented” Inspections

Source: Compiled from BIMO presentations and statistics on the FDA website

MAGI’s Clinical Trial Agreements, Budgets & Regulatory Conference

clinical trial complaints to cder
Clinical Trial Complaints to CDER

Source: Compiled from BIMO presentations and statistics on the FDA website

MAGI’s Clinical Trial Agreements, Budgets & Regulatory Conference

clinical trial complaints to cder1
Clinical Trial Complaints to CDER

Complaints lead to on-site inspections approximately 30% of the time

Most of the complaints are being submitted by drug sponsors and monitors, followed by private citizens

The complaints most likely to trigger FDA inspections are being made by clinical trial subjects

CDER views complaints as an increasingly important element of its emerging risk-based GCP compliance effort. Reporting information available at www.fda.gov/oc/gcp/complaints.html

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office of criminal inspections
Office of Criminal Inspections

Part of Office of Regulatory Affairs

Conduct FDA criminal investigations

Agents have law enforcement training

Collaborate with US Attorney and Department of Justice for prosecution

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fda resources
FDA Resources

Warning Letters available on the FDA website at www.fda.gov/foi/warning.htm

Some 483s (sponsor and IRB) available at www.fda.gov/ora/frequent/default.htm

Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) Letters atwww.fda.gov/foi/nidpoe/default.html

Clinical Investigator Inspection List available at www.fda.gov/cder/regulatory/investigators/default.htm

MAGI’s Clinical Trial Agreements, Budgets & Regulatory Conference

clinical investigator inspection list
Clinical Investigator Inspection List

Source: www.fda.gov/cder/regulatory/investigators/default.htm

MAGI’s Clinical Trial Agreements, Budgets & Regulatory Conference

slide21
This presentation and related references are posted on my corporate website at:

www.pbelow-consulting.com/fda-inspections.html

MAGI’s Clinical Trial Agreements, Budgets & Regulatory Conference

contact information
Contact Information

Office: (952) 882-4083

E-mail: [email protected]

Web: www.pbelow-consulting.com

MAGI’s Clinical Trial Agreements, Budgets & Regulatory Conference

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