美国FDA 指导原则 受试者退出FDA规定的临床试验时的数据保留 英文原版.pdfVIP

Guidance for Sponsors, Clinical Investigators, and IRBs Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials Additional copies are available from: Good Clinical Practice Program, HF-34 Office of Science Health Coordination, Office of the Commissioner Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) (301)-827-3340 /oc/gcp/draft.html U.S. Department of Health and Human Services Food and Drug Administration Office of the Commissioner (OC) Good Clinical Practice Program (GCPP) October 2008 Contains Nonbinding Recommendations TABLE OF CONTENTS I. INTRODUCTION 1 II. BACKGROUND 1 III. DISCUSSION 3 IV. FDA POLICY 5 Contains Nonbinding Recommendations 1 Guidance for Sponsors, Clinical Investigators, and IRBs Data Retention When Subjects Withdraw from FDA- Regulated Clinical Trials This guidance represents the Food and Drug Administrations (FDAs) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an