美国FDA 指导原则 修订后的共同规则某些条款对FDA规定的临床试验指南的影响 英文原版.pdfVIP

Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations Guidance for Sponsors, Investigators, and Institutional Review Boards Submit one set of either electronic or written comments on this guidance at any time. Submit electronic comments to . Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You should identify all comments with the docket number FDA-2018- D-3551. Additional copies are available from the Office of Good Clinical Practice, Office of Special Medical Programs, Office of Medical Products and Tobacco, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993 or by calling 301-796-8340, or from the Internet at /ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformati onSheetsandNotices/ucm219433.htm For questions regarding this document, contact Karena Cooper, Office of Good Clinical Practice, 301-796-1612. U.S. Department of Health and Human Services Food and Drug Administration Office of Good Clinical Practice (OGCP) October 2018 Contains Nonbinding Recommendations Table of Contents I. INTRODUCTION 1 II. BACKGROUND 2 III. INFORMED CONSENT 3 IV. EXPEDITED REVIEW PROCEDURES AND LIST 3 V. IRB CONTINUING REVIEW 4 VI. FURTHER CLARIFICATION 4 APPENDIX.…………………………………………………………………………….………...5 Contains Nonbinding Recommendations Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations Guidance for Sponsors, Investigators, and IRBs This guidance represents the curr