(英文版)医疗器械临床试验质量管理规范方案

nsoftheprotocolsuchasinvestigator’sbrochure.Thedetailedinformationofclinicaltrialinstitution,agreementoftrialresultspublishing,financeandinsurancecanbeindicatedinthetrialprotocolorcanalsomakeanotheragreementtospecifiedit.Article29Theclinicaltrialinmulti-ordancewiththesametrialprotocolindifferentclinicaltrialinstitutionsatthesametime.Thedesignandimplementationofthetrialprotocolshallatleastincludethefollowingcontents:anizedtoformulatebythesponsoranddeterminedbyeachclinicaltrialinstitutionandtheinvestigator,andthecaseshouldbeclearedthattheinvestigatorofleadunitofclinicaltrialinstitutioniscoordinatinginvestigator.anizingthemeetingofinvestigatorsintheearly,middle,latestageofclinicaltrial,andresponsiblefortheimplementationofthewholetrialwiththesponsor;pleteclinicaltrialsatthesametimeinprinciple;