Data integrity-conduct of clinical investigations: university investigator perspective

Clinical investigations are studies designed to evaluate the effectiveness of a new animal drug. Expectations for documentation of events occurring during clinical investigations have been greatly increased. The Food and Drug Administration (FDA) through its Center for Veterinary Medicine (CVM) division recently issued a guideline to address the responsibilities (under 21 CFR 511.1 and 512[j] of the Federal, Food, Drug and Cosmetic Act) of investigators who conduct clinical investigations of new animal drugs and of monitors of these investigations. The guideline is part of a continuing effort by FDA/CVM to propose data integrity initiatives that will continue to assure the reliability and accuracy of the data upon which decisions to approve new animal drugs are based. In addition to the increased documentation, FDA/CVM intends to make real-time inspection of clinical investigations a routine practice. In response to these changes; those involved with clinical investigations will need to make appropriate adjustments. The purpose of this review is to provide additional notification to clinical investigators of the changes in their responsibilities under the new guideline and to provide an investigator perspective of how these changes might impact research efforts.