title: The responsibilities of investigators, monitors, and sponsors of clinical studies supporting new animal drug applications. Center for Veterinary Medicine, FDA.
abstract: Clinical studies evaluating the effectiveness of investigational new animal drugs are conducted to support approval of a new animal drug application. These studies must be conducted in a manner that ensures the integrity and validity of the collected data. On November 2, 1992, the Center for Veterinary Medicine announced the availability of a guideline entitled "Conduct of Clinical Investigations: Responsibilities of Clinical Investigators and Monitors for Investigational New Animal Drug Studies." This guideline, which provides recommendations on the conduct of clinical investigations and the responsibilities of monitors and investigators, is presented in this manuscript. Additionally, the responsibilities of sponsors as delineated by the Food and Drug Administration's laws and regulations are also summarized.
authors.affiliation: Center for Veterinary Medicine, Food and Drug Administration, Rockville, MD 20855, USA.
authors.forename: H M
authors.initials: HM
authors.lastname: Schoenemann
authors.forename: J F
authors.initials: JF
authors.lastname: McCormack
authors.forename: K O
authors.initials: KO
authors.lastname: Smedley
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic / Q000592:standards*; D003625:Data Collection; D016903:Drug Monitoring / Q000592:standards*; D017387:Investigational New Drug Application; D015203:Reproducibility of Results; D014481:United States; D014486:United States Food and Drug Administration; D014730:Veterinary Medicine