Construction and Management of Drug Clinical Trial Institution in Our Hospital / 中国药房

ABSTRACT

OBJECTIVE:To provide reference for the construction and management of hospital clinical drug trial institution. METHODS: The practice of our hospital in the construction and management of hospital clinical drug trial institution in accordance with the Good Clinical Practice and the Trial Provisions for Drug Clinical Trial Institution Qualification was summarized. RESULTS: Hospital attached great importance by taking effective measures,strengthening the construction of software and hardware and emphasizing reforming was the key to pass the qualification confirmation,and the key points in the management are to tighten control on the clinical trial process and establish complete management regulations. CONCLUSION: The construction and management of hospital clinical drug trial institution is conducive to the improvement of clinical trial level and it serves as a scientific,accurate and reliable basis for the evaluation and marketing approval of new drugs.