Responsibilities of university investigators when conducting trials on investigational new animal drugs.

Before the start of an Investigational New Animal Drug clinical investigation, the trial protocol is written and signed by both investigator and monitor. Responsibilities of the investigator are discussed with the monitor, and a Statement of Investigator form is complied by the investigator. The monitor will provide the investigator with copies of all regulatory notifications that are submitted to the Center for Veterinary Medicine (CVM). Investigator's responsibilities include maintaining accurate records, reporting periodically to the monitor and(or) sponsor, making records available to the sponsor and carrying out the clinical investigation according to the protocol. The Food and Drug Administration by regulation has the responsibility to determine that trials are conducted in compliance with federal guidelines. The investigator should document all meetings, actions and significant events of the clinical investigation to demonstrate that federal regulations and protocol were followed. The experimental drug should be accurately monitored and dispensed during the trial and properly disposed of at the end of the study. Only the animals authorized by CVM should receive the experimental drug. During the clinical investigation, the disposition of all experimental animals should be known and at the end of the study all animals should be disposed of according to the protocol.