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Research Responsibilities and Compliance

FDA Inspections

The Food and Drug Administration (FDA) Bioresearch Monitoring Program (BIMO) oversees FDA-regulated research by performing site visits to clinical investigators, sponsors, Institutional Review Boards (IRBs) and non-clinical animal laboratories. Site visits help to assure that human subjects and animals are protected from undue hazards and to verify that research data supporting new human and animal product approvals are reliable.

FDA conducts inspections to determine if investigators are in compliance with FDA regulations. Inspections can be announced or unannounced. Most inspections are routinely performed to verify data submitted to FDA (e.g., at sites enrolling the largest number of subjects), but can also occur as a result of a complaint made to FDA, due to sponsor concerns, as a result of a review division request within FDA, or based upon current and ongoing public health issues.

Preparing for an Inspection

  1. Determine the nature (i.e., “for cause,” routine, etc.) and the scope of the audit. What protocols will be reviewed? How long will the FDA inspector(s) be on-site?
  2. Routine inspections are generally scheduled within ten (10) working days of the initial contact and cannot be postponed without sufficient justification.
  3. Inform the following groups (as applicable) when initially contacted by FDA so that each party can prepare for the visit, as necessary:
    1. research team and ancillary support services (e.g., pharmacy, nursing, Medical Information Management, etc.)
    2. department Chair and College/Center officials
    3. Office of Responsible Research Practices (ORRP) staff supporting the Institutional Review Board (IRB)
    4. Animal Care and Use Program (ACUP) staff supporting the Institutional Laboratory Animal Care and Use Committee (IACUC)
    5. Ohio State Sponsored Program Officer, Sponsor, and/or Contract Research Organization (CRO)
    6. Office of Research Compliance (ORC) if the inspection is “for cause”
  4. Schedule an appropriate room for the auditors. Provide the FDA inspector(s) with office supplies, access to a copier and fax machine, and a list of staff contact names and telephone/pager numbers.
  5. Pre-review all research records (medical and regulatory), and make them available to the inspector(s) at the time of the site visit. Investigators must allow the FDA to access, copy and verify any case history and/or drug or device administration records made by the research team or others.
  6. At the conclusion of the site visit, the FDA inspector conducts an exit interview with the principal investigator and associated research team members. A written “Inspectional Observations” (Form FDA 483) is typically generated if deficiencies are found.
  7. Forward a copy of post-audit communications and/or FDA Form 483 to the research team, Department Chair, and IRB or IACUC, as applicable. Consult with ORRP staff as needed for assistance in responding to audit findings.