Transcription of Analysis Data Model Implementation Guide
1 Analysis data Model Implementation Guide Version Prepared by the CDISC Analysis data Model Team Notes to Readers This Implementation Guide is Version and corresponds to Version of the CDISC Analysis data Model . Revision History Date Version Summary of Changes 2016-02-12 Final Released version reflecting all changes and corrections identified during comment period. 2014-05-23 Draft Draft for Public Comment 2009-12-17 Final Note: Please see Appendix C for Representations and Warranties; Limitations of Liability, and Disclaimers. CDISC ADaM Implementation Guide Version 2016 Clinical data Interchange Standards Consortium, Inc.
2 All rights reserved Page 2 Final February 12, 2016 CONTENTS 1 INTRODUCTION .. 4 PURPOSE .. 4 BACKGROUND .. 4 WHAT IS COVERED IN THE ADAMIG .. 4 Other ADaM-Related CDISC Documents .. 5 ORGANIZATION OF THIS DOCUMENT .. 6 DEFINITIONS .. 6 General ADaM Definitions .. 6 Basic data Structure Definitions .. 7 Analysis DATASETS AND ADAM 7 2 FUNDAMENTALS OF THE ADAM STANDARD .. 10 FUNDAMENTAL PRINCIPLES .. 10 TRACEABILITY .. 10 THE ADAM data STRUCTURES .. 11 The ADaM Subject-Level Analysis Dataset (ADSL) .. 11 The ADaM Basic data Structure (BDS) .. 12 3 STANDARD ADAM VARIABLES.
3 13 ADAM VARIABLE CONVENTIONS .. 14 General Variable Conventions .. 14 Timing Variable Conventions .. 15 Date and Time Imputation Flag Variables .. 17 Flag Variable Conventions .. 18 Variable Naming 18 Additional Information about Section 3 .. 21 ADSL VARIABLES .. 21 ADAM BASIC data STRUCTURE (BDS) 31 Identifier Variables for BDS Datasets .. 31 Record-Level Treatment and Dose Variables for BDS Datasets .. 32 Timing Variables for BDS Datasets .. 34 Analysis Parameter Variables for BDS Datasets .. 40 Analysis Descriptor Variables for BDS Datasets .. 44 Time-to-Event Variables for BDS Datasets.
4 47 Toxicity and Range Variables for BDS Datasets .. 48 Indicator Variables for BDS Datasets .. 50 Datapoint Traceability Variables .. 52 Analysis -ENABLING VARIABLES .. 53 DIFFERENCES BETWEEN SDTM AND ADAM POPULATION AND BASELINE FLAGS .. 54 4 Implementation ISSUES, STANDARD SOLUTIONS, AND EXAMPLES .. 55 EXAMPLES OF TREATMENT VARIABLES FOR COMMON TRIAL DESIGNS .. 55 CREATION OF DERIVED COLUMNS VERSUS CREATION OF DERIVED ROWS .. 57 Rules for the Creation of Rows and Columns .. 58 INCLUSION OF ALL OBSERVED AND DERIVED RECORDS FOR A PARAMETER VERSUS THE SUBSET OF RECORDS USED FOR Analysis .
5 70 ADaM Methodology and Examples .. 71 INCLUSION OF INPUT data THAT ARE NOT ANALYZED BUT THAT SUPPORT A DERIVATION IN THE ADAM DATASET .. 73 ADaM Methodology and Examples .. 73 IDENTIFICATION OF ROWS USED FOR Analysis .. 78 Identification of Rows Used in a Timepoint Imputation Analysis .. 78 CDISC ADaM Implementation Guide Version 2016 Clinical data Interchange Standards Consortium, Inc. All rights reserved Page 3 Final February 12, 2016 ADaM Methodology and Examples .. 78 Identification of Baseline Rows .. 80 ADaM Methodology and Examples .. 80 Identification of Post-Baseline Conceptual Timepoint Rows.
6 81 ADaM Methodology and Examples .. 81 Identification of Rows Used for Analysis General Case .. 83 ADaM Methodology and Examples .. 83 IDENTIFICATION OF POPULATION-SPECIFIC ANALYZED ROWS .. 85 ADaM Methodology and Examples .. 85 IDENTIFICATION OF ROWS WHICH SATISFY A PREDEFINED CRITERION FOR Analysis PURPOSES .. 88 ADaM Methodology and Examples When the Criterion Has Binary Responses .. 88 ADaM Methodology and Examples When the Criterion Has Multiple Responses .. 91 EXAMPLES OF TIMING VARIABLES .. 94 Example of Phase, Period and Subperiod Variables .. 94 OTHER ISSUES TO CONSIDER.
7 94 Adding Records to Create a Full Complement of Analysis Timepoints for Every 94 Creating Multiple Datasets to Support Analysis of the Same Type of 95 Size of ADaM Datasets .. 95 Traceability When the Multiple Imputation Method is Used .. 95 Copying Values onto a New Record .. 95 APPENDICES .. 97 APPENDIX A: ABBREVIATIONS AND ACRONYMS .. 97 APPENDIX B: REVISION HISTORY .. 98 APPENDIX C: REPRESENTATIONS AND WARRANTIES; LIMITATIONS OF LIABILITY, AND DISCLAIMERS .. 104 CDISC ADaM Implementation Guide Version 2016 Clinical data Interchange Standards Consortium, Inc. All rights reserved Page 4 Final February 12, 2016 1 Introduction Purpose This document comprises the Clinical data Interchange Standards Consortium (CDISC) Version of the Analysis data Model Implementation Guide (ADaMIG), which has been prepared by the Analysis data Model (ADaM) Team of CDISC.
8 The ADaMIG specifies ADaM standard dataset structures and variables, including naming conventions. It also specifies standard solutions to Implementation issues. The ADaMIG must be used in close concert with the current version of the document titled Analysis data Model (ADaM) which is available for download at That document explains the purpose of the Analysis data Model . It describes fundamental principles that apply to all Analysis datasets, with the driving principle being that the design of ADaM datasets and associated metadata facilitate explicit communication of the content of, input to, and purpose of submitted ADaM datasets.
9 The Analysis data Model supports efficient generation, replication , and review of Analysis results. Note that in the remainder of the ADaMIG, the document titled Analysis data Model (ADaM) is referred to as the ADaM Model document. Background Readers of this Implementation Guide should be familiar with the CDISC Study data Tabulation Model (SDTM) and the Study data Tabulation Model Implementation Guide (SDTMIG), both of which are available at , since SDTM is the source for ADaM data . Both the SDTM and ADaM standards were designed to support submission to a regulatory agency such as the United States Food and Drug Administration (FDA).
10 Since inception, the CDISC ADaM Team has been encouraged and informed by FDA statistical and medical reviewers who participate in ADaM meetings as observers, and who have participated in CDISC-FDA pilots. The origin of the fundamental principles of ADaM is the need for transparency of communication with and scientifically valid review by regulatory agencies. The ADaM standard has been developed to meet the needs of the FDA and industry. ADaM is applicable to a wide range of drug development activities in addition to FDA regulatory submissions. It provides a standard for transferring datasets between sponsors and contract research organizations (CROs), development partners, and independent data monitoring committees.
