FDA关于使用剩余的、去掉识别的样本的某些研究的知情同意要求的政策在FDA指南 “Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable[2]”中有所概述。 对于提交的所有样本类型,考核方法应表现出至少≥80%的灵敏度。对于不太灵...
FDA临床方案模板PREFACEThisdocumentistheDMIDprotocoltemplate,whichisrequiredfordevelopingDMID-sponsoredclinicalresearchprotocols.Notethatinstructionsandexplanatorytextareindicatedbyitalicsandshouldbereplacedinyourprotocoldocumentwithappropriateprotocol-specific 2、text.Sectionheadingsandtemplatetextformattedinregulartypeshouldbe...
Refer questions regarding use of this protocol template to the appropriate DMID Protocol Champion or Clinical Affairs Specialist. TITLE DMID Protocol Number: DMID Funding Mechanism:., grant #, contract #) Pharmaceutical Support Provided by:(if applicable) Other Identifying Numbers: IND Sponsor:(if ...
FDA 临床方案模板.doc,PREFACE This document is the DMID protocol template, which is required for developing DMID-sponsored clinical research protocols. Note that instructions and explanatory text are indicated by italics and should be replaced in your pro
需要金币:*** 金币(10金币=人民币1元) 美国FDA 指导原则 申办者、临床研究者和irb的信息表指南常见问题研究者声明(FDA 1572表格)(修订版1):申办者、临床研究者和irb的信息表指南草案常见问题研究者声明(表格FDA 1572)(修订版1) 英文原版.pdf 关闭预览 ...
(ICH-GCP)andtheapplicableregulatoryrequirements.Usetheapplicableregulationsandrequirementsdependingonstudylocationandsponsorrequirements.Examplesofrequirementsthatarepotentiallyapplicableinclude: U.S.CodeofFederalRegulationsapplicabletoclinicalstudies(45CFR46and21CFRincludingparts50and56concerninginformedconsentandIRBregulations...
application a confirmed clinical trial protocol, the name of the principal investigator at the institution in charge of the clinical trial, a list of participating institutions and names of investigators wherefrom, an ethic committee approval letter, and a template of the informed consent form, etc...
39、BrochureICFInformed Consent FormICHInternational Conference on HarmonisationIDEInvestigational Device ExemptionIECIndependent or Institutional Ethics CommitteeINDInvestigational New DrugIRBInstitutional Review BoardISMIndependent Safety MonitorJAMAJournal of the American Medical AssociationMedDRA Me 40、dical Dictiona...
需要金币:*** 金币(10金币=人民币1元) 美国FDA 指导原则 人体细胞治疗化学、制造和控制(CMC)信息的内容和综述FDA审查和赞助商新药应用(INDS)指南 英文原版.pdf 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 Guidance for FDA Reviewers and Sponsors Content and Review of Chemistry, Manufactur...