［分享］最新版本 FDA CDISC SDTM Implementation Guide (Version 3.1.2)-经管之家官网！

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［分享］最新版本 FDA CDISC SDTM Implementation Guide (Version 3.1.2)

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

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