SDTM 3.1.1 Implementation Guide
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- 1 Submission Data Standards Version 3.1.1
- Implementation Guide for the Study Data Tabulation Model
- 1 INTRODUCTION
- 2 FUNDAMENTALS OF THE SDTM
- 3 SUBMITTING DATA IN STANDARD FORMAT
- 4 ASSUMPTIONS FOR DOMAIN MODELS
- 4.1 GENERAL ASSUMPTIONS FOR ALL DOMAINS
- 4.1.1 General Dataset Assumptions
- 4.1.1.1 Review the Study Data Tabulation Model as well as this Imple
- 4.1.1.2 Additional analysis variables should be added to analysis da
- 4.1.1.3 Additional Timing variables from the general observation cla
- 4.1.1.4 The order of variables in the Define data definition documen
- 4.1.1.5 CDISC Core variables: In V3.0, CDISC identified all Core va
- 4.1.1.6 Additional guidance on dataset naming will be provided in fu
- 4.1.2 General Variable Assumptions
- 4.1.2.1 Data variable names should be limited to 8 characters, and c
- 4.1.2.2 In order to minimize the risk of difficulty when merging/joi
- 4.1.2.3 'Subject' should be used where applicable to generically ref
- 4.1.2.4 It is recommended that textual data be submitted in upper ca
- 4.1.2.5 If a special convention is used for missing values (or value
- 4.1.2.6 Sponsors may assign categories (--CAT variable) and subcateg
- 4.1.3 Coding and Controlled Terminology Assumptions
- 4.1.3.1 The Submission Data Standards Team has defined two types of
- 4.1.3.2 It is recommended that controlled terminology be submitted i
- 4.1.3.3 The controlled terminology should be displayed for each appl
- 4.1.3.4 Controlled terminology or text should be used instead of, or
- 4.1.3.5 Controlled terminology for domain topic variables should be
- 4.1.3.6 The topic variable for many of the general domain models is
- 4.1.3.7 Variables where the response is 'Yes' or 'No' ('Y'/'N') shou
- 4.1.4 Actual and Relative Time Assumptions
- 4.1.4.1 Date/Time formats for --DTC Variables: The CDISC SDS V2 mod
- 4.1.4.2 Date/Time Precision. In V3.0, a separate date/time precisio
- 4.1.4.3 Duration is frequently used during a review; however, the du
- 4.1.4.4 The Study Day variable (--DY) describes the relative day of
- 4.1.4.5 Clinical encounters are described by the CDISC Visit variabl
- 4.1.4.6 The calculation of study days within subdivisions of time in
- 4.1.4.7 The CDISC V2/V3 domain models included the timing variables
- 4.1.4.8 When the date and time of collection is reported in a domain
- 4.1.5 Other Assumptions
- 4.1.1 General Dataset Assumptions
- 4.1 GENERAL ASSUMPTIONS FOR ALL DOMAINS
- 5 MODELS FOR SPECIAL PURPOSE DOMAINS
- 6 DOMAIN MODELS BASED ON THE GENERAL CLASSES
- 7 TRIAL DESIGN DATASETS
- 8 REPRESENTING DATA RELATIONSHIPS
- 9 IMPLEMENTATION EXAMPLES
- 10 APPENDICES