DATA INTEGRITY-CONDUCT OF CLINICAL INVESTIGATIONS - UNIVERSITY INVESTIGATOR PERSPECTIVE

Clinical investigations are studies designed to evaluate the effective ness of a new animal drug. Expectations for documentation of events oc curring during clinical investigations have been greatly increased. Th e Food and Drug Administration (FDA) through its Center for Veterinary Medicine (CVM) division recently issued a guideline to address the re sponsibilities (under 21 CFR 511.1 and 512[j] of the Federal, Food, Dr ug and Cosmetic Act) of investigators who conduct clinical investigati ons of new animal drugs and of monitors of these investigations. The g uideline is part of a continuing effort by FDA/CVM to propose data int egrity initiatives that will continue to assure the reliability and ac curacy of the data upon which decisions to approve new animal drugs ar e based. In addition to the increased documentation, FDA/CVM intends t o make real-time inspection of clinical investigations a routine pract ice. In response to these changes, those involved with clinical invest igations will need to make appropriate adjustments. The purpose of thi s review is to provide additional notification to clinical investigato rs of the changes in their responsibilities under the new guideline an d to provide an investigator perspective of how these changes might im pact research efforts.