Statement by Mary K. Pendergast, Deputy Commissioner, Senior Advisor to the Commissioner, Food and Drug Administration, Department of Health and Human Services

FDA's Inspections of Clinical Investigators
Under the Clinical Investigator Program, FDA conducts studyspecific inspections and audits of physicians and other
investigators conducting clinical trials of FDA-regulated
products. In Fiscal Year 1996 FDA conducted approximately 700
clinical investigator inspections.
FDA carries out two principal types of clinical investigator
inspections: 1) study-oriented inspections; and
2) investigator-oriented inspections. Study-oriented
inspections are conducted on studies that are important to
product marketing applications, such as new drug applications
(NDAs), product license applications (PLAs) for biological
products, and premarket approval applications (PMAs) for
medical devices, that are pending before the Agency.
The Agency routinely inspects and audits the pivotal studies
upon which the Agency intends to base marketing approval of a
new product. In these inspections and audits, FDA examines
study records and findings, giving particular attention to
protocol adherence and data integrity. We also look for
documentation of informed consent and IRB review, approval, and
continuing review of ongoing studies.
An investigator-oriented inspection may be initiated as a

result of complaints received from subjects about alleged human

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