美国FDA 指导原则 机构审查委员会(IRB)机构和机构审查机构的书面程序指南 英文原版.pdf

Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs U.S. Department of Health and Human Services Office for Human Research Protections (OHRP) U.S. Department of Health and Human Services Food and Drug Administration Office of Good Clinical Practice (OGCP) Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Office of Regulatory Affairs (ORA) May 2018 Contains Nonbinding Recommendations Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs Additional copies are available from: Division of Policy and Assurances Office for Human Research Protections 1101 Wootton Parkway, Suite 200 Rockville, MD 20852 (Tel) 240-453-6900 or 866-447-4777 (Fax) 301-402-2071 /ohrp/regulations-and-policy/guidance/alphabetical -list/index.html or Office of Good Clinical Practice Office of Special Medical Programs, Office of Medical Products and Tobacco Food and Drug Administration 10903 New Hampshire Avenue WO32-5103 Silver Spr