随着国内医疗器械产业的发展，相信中国企业对产品销往美国、欧盟的声明、认证、注册等过程应该是轻车熟路。我们今天换点别的口味，小编从最近的项目中，整理了美国FDA临床过程的文件清单，给各位看官们过过目。No.Requirement Item1Investigator’s Brochure2CRF Case Report Form3Information Given to Trial Subject4Financial Aspects of the Trial5Insurance Statement6Signed Agreement between Involved Parties (sponsor/CRO/Investigator/Institution/Authories)7IRB Approval Original Document8IRB Composition List (Staff List)9FDA Authorisazion/ Approval10Curriculum Vitae or Other Evidencing Qualification Investigator11Normal Values/Range/Procedure (Any standardized operation procedure)12Medical Quality (Quality procedure in trail)13Device Labels for Investigation14Shipping Records for Investigational Device15Certificate of Analysis （CoA）16Decoding Procedures for Blinded Trials17Master Randomization List18(Pre-trial) Monitoring Report19Trial Initiation Monitoring Report20If applicable, Investigator’s Brochure Updates do you have procedure.21If applicable, amendments for CRF form22If applicable, IRB/IEC’s amendments23Sites Visit Reports24Signed Information Consent Forms25Serious Adverse Events/ Related Reports26Notification from sponsor or investigators of safety information27Interim or annual reports provided to IRB/IEC28Subject Screening Log29Subject Identification Code List30Subject Enrolment Log31Signature Sheet for CRF including Correction32If any trial repeated on one subject location, Please make the record.33Investigational Product Accountability FOR EACH SITE34Device Destruction Record35Completed Subject Identification Code List36Audit Record If Exists37Final Trial Close-out Monitoring Report因为这次时间紧，下期我们对每个临床文件进行讲解说明。因为这次时间紧，下期我们对每个临床文件进行讲解说明。
