做好专科医院申报国家药物临床试验机构资格认定工作

Practice and Approach of Applying for Accreditation of National Drug Clinical Trial Institution by Specialized Hospitals

目的为专科医院申报国家药物临床试验机构提供借鉴。方法参阅国家关于药物临床试验机构资格认定的相关规定,结合专科医院的特点、阐述专科医院在申请资格认定过程中的实际操作和体会。结果与结论专科医院申报国家药物临床试验机构需明了自身劣势,挖掘临床优势资源、强化优势专业、合理利用外部资源以弥补自身不足。

OBJECTIVE To provide some references for speciaslized hospital to apply for national drug clinical trial institution. METHODS According to the state on related clinical test qualification of the relevant provisions, combined with the characteristics of specialist hospitals, we described in the application process of qualification and experience of the actual operation. RESULTS AND CONCLUSION Specialized hospital should understand our own weaknesses, mining clinical advantages of resources, strengthen pro- fessional advantages, with rational use of external resources in order to make up for our lack.