各种类型的临床研究报告介绍.pdfVIP

AN INTRODUCTION TO VARIOUS TYPES OF CLINICAL STUDY REPORTS Page 2 CSR Purpose The CSRs describe the results of human studies. They are written whether or not the studies are success or failure. In a submission, CSRs form the base of the clinical portion (Module 5) of the Common Technical Document (CTD) and feed into the clinical summary documents. © 2021 DIA, Inc. All rights reserved.