FDA 483 - National Cancer Institute, Cancer Therapy Evaluation Program - July 17, 2014

The FDA inspected the National Cancer Institute, Cancer Therapy Evaluation Program, revealing significant deficiencies in the oversight of clinical investigations. Observations included failures to ensure investigator qualifications, adequately monitor study progress, obtain complete FDA-1572 statements, and collect required financial disclosure information from investigators. These issues indicate a lack of adherence to regulatory requirements for clinical trial conduct.