Schoenemann H M, McCormack J F, Smedley K O
Center for Veterinary Medicine, Food and Drug Administration, Rockville, MD 20855, USA.
J Anim Sci. 1995 Feb;73(2):606-13; discussion 612-3. doi: 10.2527/1995.732606x.
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.
评估新动物用研究性药物有效性的临床研究旨在支持新动物用药物申请的获批。这些研究必须以确保所收集数据的完整性和有效性的方式进行。1992年11月2日，兽药中心宣布发布一项指南，题为《临床研究的开展：新动物用研究性药物研究的临床研究者和监查员的职责》。本指南提供了关于临床研究开展以及监查员和研究者职责的建议，现呈现于此文稿中。此外，还总结了食品药品监督管理局法律法规所规定的申办者的职责。
