售价: 论坛币 ５ 个  [记录]  [购买] [分享]CDISC SDTM Implementation Guide (Version 3.1.2)最新版本Study Data Tabulation Model  Implementation Guide: Human Clinical Trials  Prepared by the CDISC Submission Data Standards Team  CONTENTS
1  INTRODUCTION  ................................................................................................... 7
1.1  PURPOSE  .............................................................................................................................................................  7
1.2  ORGANIZATION OF THIS DOCUMENT  ...................................................................................................................  7
1.3  RELATIONSHIP TO PRIOR CDISC DOCUMENTS  ...................................................................................................  8
1.4  HOW TO READ THIS IMPLEMENTATION GUIDE  ....................................................................................................  9
1.5  SUBMITTING COMMENTS  ....................................................................................................................................  9
2  FUNDAMENTALS OF THE SDTM  ...................................................................... 10
2.1  OBSERVATIONS AND VARIABLES  .......................................................................................................................  10
2.2  DATASETS AND DOMAINS  .................................................................................................................................  11
2.3  SPECIAL-PURPOSE DATASETS  ...........................................................................................................................  12
2.4  THE GENERAL OBSERVATION CLASSES  .............................................................................................................  12
2.5  THE SDTM STANDARD DOMAIN MODELS .......................................................................................................  13
2.6  CREATING A NEW DOMAIN  ...............................................................................................................................  14
3  SUBMITTING DATA IN STANDARD FORMAT  .................................................. 16
3.1  STANDARD METADATA FOR DATASET CONTENTS AND ATTRIBUTES  ..................................................................  16
3.2  USING THE CDISC DOMAIN MODELS IN REGULATORY SUBMISSIONS — DATASET METADATA .......................  17
3.2.1.1  Primary Keys  .......................................................................................................................................  19
3.2.1.2  CDISC Submission Value-Level Metadata  ..........................................................................................  20
3.2.2  Conformance........................................................................................................................................  20
4  ASSUMPTIONS FOR DOMAIN MODELS .......................................................... 21
4.1  GENERAL ASSUMPTIONS FOR ALL DOMAINS  ....................................................................................................  21
4.1.1  General Domain Assumptions .............................................................................................................  21
4.1.1.1  Review Study Data Tabulation and Implementation Guide  .................................................................  21
4.1.1.2  Relationship to Analysis Datasets  ........................................................................................................  21
4.1.1.3  Additional Timing Variables  ................................................................................................................  21
4.1.1.4  Order of the Variables  ..........................................................................................................................  21
4.1.1.5  CDISC Core Variables  .........................................................................................................................  21
4.1.1.6  Additional Guidance on Dataset Naming ............................................................................................  22
4.1.1.7  Splitting Domains  ................................................................................................................................  22
4.1.1.8  Origin Metadata  ...................................................................................................................................  25
4.1.1.9  Assigning Natural Keys in the Metadata .............................................................................................  26
4.1.2  General Variable Assumptions  .............................................................................................................  28
4.1.2.1  Variable-Naming Conventions  .............................................................................................................  28
4.1.2.2  Two-Character Domain Identifier  ........................................................................................................  28
4.1.2.3  Use of ―Subject‖ and USUBJID  ..........................................................................................................  29
4.1.2.4  Case Use of Text in Submitted Data  ....................................................................................................  29
4.1.2.5  Convention for Missing Values  ............................................................................................................  29
4.1.2.6  Grouping Variables and Categorization  ...............................................................................................  29
4.1.2.7  Submitting Free Text from the CRF.....................................................................................................  31
4.1.2.8  Multiple Values for a Variable .............................................................................................................  33
4.1.3  Coding and Controlled Terminology Assumptions  ..............................................................................  35
4.1.3.1  Types of Controlled Terminology  ........................................................................................................  35
4.1.3.2  Controlled Terminology Text Case  ......................................................................................................  35
4.1.3.3  Controlled Terminology Values ...........................................................................................................  35
4.1.3.4  Use of Controlled Terminology and Arbitrary Number Codes  ............................................................  36
4.1.3.5  Storing Controlled Terminology for Synonym Qualifier Variables .....................................................  36
4.1.3.6  Storing Topic Variables for General Domain Models  ..........................................................................  36
4.1.3.7  Use of ―Yes‖ and ―No‖ Values  .............................................................................................................  36 4.1.4  Actual and Relative Time Assumptions  ...............................................................................................  37
4.1.4.1  Formats for Date/Time Variables  .........................................................................................................  37
4.1.4.2  Date/Time Precision  .............................................................................................................................  38
4.1.4.3  Intervals of Time and Use of Duration for --DUR Variables  ...............................................................  39
4.1.4.4  Use of the ―Study Day‖ Variables  ........................................................................................................  40
4.1.4.5  Clinical Encounters and Visits  .............................................................................................................  41
4.1.4.6  Representing Additional Study Days  ...................................................................................................  41
4.1.4.7  Use of Relative Timing Variables ........................................................................................................  42
4.1.4.8  Date and Time Reported in a Domain Based on Findings  ...................................................................  44
4.1.4.9  Use of Dates as Result Variables..........................................................................................................  44
4.1.4.10  Representing Time Points  ....................................................................................................................  44