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ID:40089099
大小:236.29 KB
页数:5页
时间:2019-07-20
《Principle for responsible Clinical trial data sharing》由会员上传分享,免费在线阅读,更多相关内容在学术论文-天天文库。
1、PrinciplesforResponsibleClinicalTrialDataSharingOurCommitmenttoPatientsandResearchersBiopharmaceuticalcompaniesarecommittedtoenhancingpublichealththroughresponsiblesharingofclinicaltrialdatainamannerthatisconsistentwiththefollowingPrinciples:•Safeguardingthepriv
2、acyofpatients•Respectingtheintegrityofnationalregulatorysystems•MaintainingincentivesforinvestmentinbiomedicalresearchCompaniesroutinelypublishtheirclinicalresearch,Eachcompanywillestablishascientificreviewboardthatcollaboratewithacademicresearchers,andshareclin
3、icalwillincludescientistsand/orhealthcareprofessionalstrialinformationonpublicwebsitesatthetimeofwhoarenotemployeesofthecompany.Membersofpatientrecruitment,afternewdrugapproval,andwhenthescientificreviewboardswillparticipateinthereviewinvestigationalresearchprog
4、ramshavebeendiscontinued.ofdatarequeststodeterminewhethertheymeetthecriteriadescribedbelowregardingthequalificationsofBiopharmaceuticalcompanieswillapplythesePrinciplestherequestorandthelegitimacyoftheresearchpurpose,forResponsibleClinicalTrialDataSharingasacomm
5、onunlessacompanymakesaninitialdeterminationonitsbaselineonavoluntarybasis,andweencourageallowntoshareapplicableclinicaltrialdata.Companiesmedicalresearchers,includingthoseinacademiaandwillpubliclyposttheirdatarequestreviewprocessandinthegovernment,topromotemedic
6、alandscientifictheidentityoftheexternalscientistsandhealthcareadvancementbyadoptingandimplementingthefollowingprofessionalswhoparticipateinthescientificreviewcommitments:board,includinganyexistingrelationshipswithexternalboardmembers.1.EnhancingDataSharingwithRe
7、searchersBiopharmaceuticalcompaniescommittosharinguponCompanieswillprovideaccesstopatient-leveldataandrequestfromqualifiedscientificandmedicalresearchersotherclinicaltrialinformationconsistentwiththeprinciplepatient-levelclinicaltrialdata,study-levelclinicaltria
8、ldata,ofsafeguardingpatientprivacy;patients’informedandprotocolsfromclinicaltrialsinpatientsformedicinesconsentprovidedinrelationtotheirparticipationintheandindicatio
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