The FDA has Good Clinical Practice regulations governing the approval, conduct, review and reporting of clinical research intended for submission to the FDA,1 and it monitors compliance with these regulations through routine and directed (for cause) inspections.

Routine inspections are assigned for clinical drug studies conducted under New Drug Applications (NDAs) and device studies conducted under Pre Market Approvals (PMAs).

Directed or “for cause” inspections are conducted for several reasons. Some of the reasons that may trigger an audit include problems that are identified during the review process and/or complaints received by the FDA. These complaints may come from the sponsor, the local IRB or institution, subjects, the public, or other agencies

Institutional Support Preparing for and Undergoing FDA Inspections

UTHSC-H Principal Investigators and clinical staff preparing for FDA inspections should follow the steps outlined in UTHSC-H documents:

• FDA Audit Checklist
  
  
• Actions for an FDA Inspection
  

Please report an FDA audit to the UTHSC-H Office of Research as soon as possible and as outlined in these documents.

21 CFR 312: IND regulations (rev.1987), 21 CFR 50: Informed consent (rev.1981), 21 CFR 56: IRB (rev.1981), 21 CFR 314: NDA regulations (rev. 1985)