美国FDA 指导原则 提交非肝硬化性非酒精性脂肪性肝炎(NASH)临床试验数据集的技术规范行业技术规范指南文件 英文原版.pdfVIP

Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH) Guidance for Industry Technical Specifications Document For questions regarding this technical specification document, contact CDER at cder-edata@. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) January 2022 Technical Specifications Document Revision History Date Version Summary of Revisions August 2021 1.0 Initial Version Section 5.0 – Added language about CDISC Controlled Terminology January 2022 1.1 Revisions made to Section 5.1.4 - Corrected test code values for Ascites and Encephalopathy Grade. Contains Nonbinding Recommendations Table of Contents 1.0 INTRODUCTION 1 2.0 RELEVANT ACRONYMS 2 3.0 FDA DATA STANDARDS CATALOG 3 4.0 OVERVIEW OF DATA SETS 3 4.1 SDTM Domains 4 4.2 ADaM Data Sets 5 5.0 OVERVIEW OF DATA SET SPECIFICATIONS 6 5.1 SDTM Domains 7 5.1.1 Biospecimen Events (BE) Domain 7 5.1.2 Biospecimen Findings (BS) Domain 7 5.1.3 Microscopic Findings (MI) Domain 8 5.1.4 Supplemental Microscopic Findings (SUPPMI) Domain 11 5.1.5 Disease Response and Clinical Classifications (RS) Domain 12 5.1.6