本AdaMIG (v1.2)来自CDISC官网以下链接:
ADaMIG v1.2 Release Package | CDISC
Analysis Data Model Implementation Guide
Version 1.2 (Final)
Prepared by the
CDISC Analysis Data Model Team
Notes to Readers
• This Implementation Guide is Version 1.2 and corresponds to Version 2.1 of the CDISC Analysis Data Model.
• 本实施指南的版本为1.2,对应于CDISC分析数据模型的版本2.1。
Revision History
Date |
Version |
2019-10-03 |
1.2 Final |
2016-02-12 |
1.1 Final |
20009-12-17 |
1.0 Final |
CONTENTS 目录
1 INTRODUCTION (介绍)................................................................................................................. 4
1.1 PURPOSE (目的)................................................................................................................................................................ 4
1.2 BACKGROUND(背景)....................................................................................................................................................... 4
1.3 WHAT IS COVERED IN THE ADAMIG(本IG涵盖的内容).................................................................................................................... 4
1.3.1 Other ADaM-related CDISC Documents(其他与ADaM相关的CDISC文档)............................................................................................... 5
1.4 ORGANIZATION OF THIS DOCUMENT *(本文档的结构)..................................................................................................................... 6
1.5 DEFINITIONS(定义).......................................................................................................................................................... 6
1.5.1 General ADaM Definitions (通用ADaM定义).................................................................................................................... 6
1.5.2 Basic Data Structure Definitions (基本数据结构定义)............................................................................................................ 7
1.6 ANALYSIS DATASETS AND ADAM DATASETS(分析数据集和ADaM数据集)....................................................................................................... 7
1.6.1 Analysis Datasets Within the eCTD Folder Structure(eCTD文件夹结构中的分析数据集)............................................................................ 8
2 FUNDAMENTALS OF THE ADAM STANDARD (ADaM标准的基础)......................................................... 10
2.1 FUNDAMENTAL PRINCIPLES (基本原则)................................................................................................................................ 10
2.2 TRACEABILITY(可追溯性).................................................................................................................................................... 10
2.3 THE ADAM DATA STRUCTURES ADaM(数据结构)......................................................................................................................... 11
2.3.1 The ADaM Subject-Level Analysis Dataset (ADSL) ADaM(受试者级别分析数据集(ADSL)).......................................................................... 11
2.3.2 The ADaM Basic Data Structure (BDS)(ADaM基本数据结构(BDS)).............................................................................................. 12
3 STANDARD ADAM VARIABLES(标准ADaM变量)................................................................................... 13
3.1 ADAM VARIABLE CONVENTIONS (ADaM变量约定)....................................................................................................................... 13
3.1.1 General Variable Conventions(通用变量约定)............................................................................................................. 13
3.1.2 Timing Variable Conventions(时间变量约定).............................................................................................................. 15
3.1.3 Date and Time Imputation Flag Variables(日期和时间插补标志变量)........................................................................................... 16
3.1.4 Flag Variable Conventions(标志变量约定)................................................................................................................... 17
3.1.5 Variable Naming Fragments(变量命名片段)................................................................................................................. 18
3.1.6 Additional Information about Section 3(关于第3节的其他信息)............................................................................................... 20
3.2 ADSL VARIABLES (ADSL变量)..................................................................................................... 21
3.3 ADAM BASIC DATA STRUCTURE (BDS) VARIABLES(ADaM基本数据结构变量).......................................................................................... 34
3.3.1 Identifier Variables for BDS (BDS 的标识符变量).................................................................................................. 34
3.3.2 Record-Level Treatment and Dose Variables for BDS Datasets *(BDS数据集的记录水平的治疗和剂量变量).......................................................... 35
3.3.3 Timing Variables for BDS Datasets(BDS数据集的时间变量)..................................................................................................... 37
3.3.4 Analysis Parameter Variables for BDS Datasets .(BDS数据集的分析参数变量)................................................................................. 44
3.3.4.1 Analysis Parameter Variables(分析参数变量)............................................................................................................... 44
3.3.4.2 PARAM, AVAL, and AVALC ............................................................................................................ 49
3.3.4.3 Analysis Parameter Criteria Variables for BDS Datasets(BDS数据集的分析参数标准变量)..................................................................... 50
3.3.5 Analysis Descriptor Variables for BDS(BDS 的分析描述符变量)................................................................................. 51
3.3.6 Time-to-Event Variables for BDS Datasets(BDS数据集的时间-事件变量)......................................................................................... 53
3.3.7 Toxicity and Range Variables for BDS Datasets (BDS数据集的毒性和范围变量)................................................................................. 53
3.3.8 Indicator Variables for BDS Datasets