CDISC的ADaMIG (V1.2) 中英文对照【1】_目录&第一章介绍

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分类专栏： ADaM 文章标签：数据分析

于 2020-07-15 15:19:02 首次发布

本文链接：https://blog.csdn.net/PTDCDISC/article/details/107361526

版权

本文档是CDISC ADaM实施指南V1.2，对应ADaM标准的2.1版。介绍了ADaM的目的、背景、覆盖内容和结构，详细定义了ADaM的基本概念和数据结构，如分析数据集、ADSL和BDS。还探讨了ADaM变量的命名约定、分析参数、可追溯性原则等核心概念，旨在促进临床试验数据分析的标准化和透明度。

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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