SDTMIG V3.1.2 SDTM Implementation Guide

• Cover page
• Table of Contents
• 1 Introduction
  • 1.1 Purpose
  • 1.2 Organization of this Document
  • 1.3 Relationship to Prior CDISC Documents
  • 1.4 How to Read this Implementation Guide
  • 1.5 Submitting Comments
• 2 Fundamentals of the SDTM
  • 2.1 Observations and Variables
  • 2.2 Datasets and Domains
  • 2.3 Special-Purpose Datasets
  • 2.4 The General Observation Classes
  • 2.5 The SDTM Standard Domain Models
  • 2.6 Creating a New Domain
• 3 Submitting Data in Standard Format
  • 3.1 Standard Metadata for Dataset Contents and Attributes
  • 3.2 Using the CDISC Domain Models in Regulatory Submissions — Dataset Metadata
    • 3.2.1 SDTM Submission Dataset-Definition Metadata Example
      • 3.2.1.1 Primary Keys
      • 3.2.1.2 CDISC Submission Value-Level Metadata
    • 3.2.2 Conformance
• 4 Assumptions for Domain Models
  • 4.1 General Assumptions for All Domains
    • 4.1.1 General Domain Assumptions
      • 4.1.1.1 Review Study Data Tabulation and Implementation Guide
      • 4.1.1.2 Relationship to Analysis Datasets
      • 4.1.1.3 Additional Timing Variables
      • 4.1.1.4 Order of the Variables
      • 4.1.1.5 CDISC Core Variables
      • 4.1.1.6 Additional Guidance on Dataset Naming
      • 4.1.1.7 Splitting Domains
        • 4.1.1.7.1 Example of Splitting Questionnaires
      • 4.1.1.8 Origin Metadata
        • 4.1.1.8.1 Origin Metadata for Variables
        • 4.1.1.8.2 Origin Metadata for Records
      • 4.1.1.9 Assigning Natural Keys in the Metadata
    • 4.1.2 General Variable Assumptions
      • 4.1.2.1 Variable-Naming Conventions
      • 4.1.2.2 Two-Character Domain Identifier
      • 4.1.2.3 Use of “Subject” and USUBJID
      • 4.1.2.4 Case Use of Text in Submitted Data
      • 4.1.2.5 Convention for Missing Values
      • 4.1.2.6 Grouping Variables and Categorization
      • 4.1.2.7 Submitting Free Text from the CRF
        • 4.1.2.7.1 “Specify” values for Non-Result qualifier variables
        • 4.1.2.7.2 “Specify” values for result Qualifier variables
        • 4.1.2.7.3 “Specify” values for topic variables
      • 4.1.2.8 Multiple Values for a Variable
        • 4.1.2.8.1 Multiple Values for an Intervention or event Topic Variable
        • 4.1.2.8.2 Multiple Values for a Findings Result Variable
        • 4.1.2.8.3 Multiple Values for a Non-Result Qualifier Variable
    • 4.1.3 Coding and Controlled Terminology Assumptions
      • 4.1.3.1 Types of Controlled Terminology
      • 4.1.3.2 Controlled Terminology Text Case
      • 4.1.3.3 Controlled Terminology Values
      • 4.1.3.4 Use of Controlled Terminology and Arbitrary Number Codes
      • 4.1.3.5 Storing Controlled Terminology for Synonym Qualifier Variables
      • 4.1.3.6 Storing Topic Variables for General Domain Models
      • 4.1.3.7 Use of “Yes” and “No” Values
    • 4.1.4 Actual and Relative Time Assumptions
      • 4.1.4.1 Formats for Date/Time Variables
      • 4.1.4.2 Date/Time Precision
      • 4.1.4.3 Intervals of Time and Use of Duration for --DUR Variables
        • 4.1.4.3.1 Intervals of time and Use of Duration for --DUR variables
        • 4.1.4.3.2 Interval with uncertainty
      • 4.1.4.4 Use of the “Study Day” Variables
      • 4.1.4.5 Clinical Encounters and Visits
      • 4.1.4.6 Representing Additional Study Days
      • 4.1.4.7 Use of Relative Timing Variables
      • 4.1.4.8 Date and Time Reported in a Domain Based on Findings
      • 4.1.4.9 Use of Dates as Result Variables
      • 4.1.4.10 Representing Time Points
    • 4.1.5 Other Assumptions
      • 4.1.5.1 Original and Standardized Results of Findings and Tests Not Done
        • 4.1.5.1.1 Original and Standardized Results
        • 4.1.5.1.2 Tests Not Done
        • 4.1.5.1.3 Examples of Original and Standard Units and test Not Done
      • 4.1.5.2 Linking of Multiple Observations
      • 4.1.5.3 Text Strings That Exceed the Maximum Length for General-Observation-Class Domain Variables
        • 4.1.5.3.1 Test Name (--TEST) Greater than 40 Characters
        • 4.1.5.3.2 Text Strings> 200 Characters in Other Variables
      • 4.1.5.4 Evaluators in the Interventions and Events Observation Classes
      • 4.1.5.5 Clinical Significance for Findings Observation Class Data
      • 4.1.5.6 Supplemental Reason Variables
      • 4.1.5.7 Presence or Absence of Pre-Specified Interventions and Events
• 5 Models for Special-Purpose Domains
  • 5.1 Demographics
    • 5.1.1 Demographics — DM
      • 5.1.1.1 Assumptions for Demographics Domain Model
      • 5.1.1.2 Examples for Demographics Domain Model
  • 5.2 Comments
    • 5.2.1 Comments — CO
      • 5.2.1.1 Assumptions for Comments Domain Model
      • 5.2.1.2 Examples for Comments Domain Model
  • 5.3 Subject Elements and Visits
    • 5.3.1 Subject Elements — SE
      • 5.3.1.1 Assumptions for Subject Elements Domain Model
      • 5.3.1.2 Examples for Subject Elements Domain Model
    • 5.3.2 Subject Visits — SV
      • 5.3.2.1 Assumptions for Subject Visits Domain Model
      • 5.3.2.2 Examples for Subject Visits Domain Model
• 6 Domain Models Based on the General Observation Classes
  • 6.1 Interventions
    • 6.1.1 Concomitant Medications — CM
      • 6.1.1.1 Assumptions for Concomitant Medications Domain Model
      • 6.1.1.2 Examples for Concomitant Medications Domain Model
    • 6.1.2 Exposure — EX
      • 6.1.2.1 Assumptions for Exposure Domain Model
      • 6.1.2.2 Examples for Exposure Domain Model
    • 6.1.3 Substance Use — SU
      • 6.1.3.1 Assumptions for Substance Use Domain Model
      • 6.1.3.2 Example for Substance Use Domain Model
  • 6.2 Events
    • 6.2.1 Adverse Events — AE
      • 6.2.1.1 Assumptions for Adverse Event Domain Model
      • 6.2.1.2 Examples for Adverse Events Domain Model
    • 6.2.2 Disposition — DS
      • 6.2.2.1 Assumptions for Disposition Domain Model
      • 6.2.2.2 Examples for Disposition Domain Model
    • 6.2.3 Medical History — MH
      • 6.2.3.1 Assumptions for Medical History Domain Model
      • 6.2.3.2 Examples for Medical History Domain Model
    • 6.2.4 Protocol Deviations — DV
      • 6.2.4.1 Assumptions for Protocol Deviations Domain Model
      • 6.2.4.2 Examples for Protocol Deviations Domain Model
    • 6.2.5 Clinical Events — CE
      • 6.2.5.1 Assumptions for Clinical Events Domain Model
      • 6.2.5.2 Examples for Clinical Events Domain Model
  • 6.3 Findings
    • 6.3.1 ECG Test Results — EG
      • 6.3.1.1 Assumptions for ECG Test Results Domain Model
      • 6.3.1.2 Examples for ECG Test Results Domain Model
    • 6.3.2 Inclusion/Exclusion Criteria Not Met — IE
      • 6.3.2.1 Assumptions for Inclusion/Exclusion Criteria Not Met Domain Model
      • 6.3.2.2 Examples for Inclusion/Exclusion Not Met Domain Model
    • 6.3.3 Laboratory Test Results — LB
      • 6.3.3.1 Assumptions for Laboratory Test Results Domain Model
      • 6.3.3.2 Examples for Laboratory Test Results Domain Model
    • 6.3.4 Physical Examination — PE
      • 6.3.4.1 Assumptions for Physical Examination Domain Model
      • 6.3.4.2 Examples for Physical Examination Domain Model
    • 6.3.5 Questionnaire — QS
      • 6.3.5.1 Assumptions for Questionnaire Domain Model
      • 6.3.5.2 Examples for Questionnaire Domain Model
    • 6.3.6 Subject Characteristics — SC
      • 6.3.6.1 Assumptions for Subject Characteristics Domain Model
      • 6.3.6.2 Example for Subject Charactistics Domain Model
    • 6.3.7 Vital Signs — VS
      • 6.3.7.1 Assumptions for Vital Signs Domain Model
      • 6.3.7.2 Example for Vital Signs Domain Model
    • 6.3.8 Drug Accountability — DA
      • 6.3.8.1 Assumptions for Drug Accountability Domain Model
      • 6.3.8.2 Examples for Drug Accountability Domain Model
    • 6.3.9 Microbiology Domains — MB and 1104HMS
      • 6.3.9.1 Microbiology Specimen (MB) Domain Model
      • 6.3.9.2 Assumptions for Microbiology Specimen (MB) Domain Model
      • 6.3.9.3 Microbiology Susceptibility (MS) Domain Model
      • 6.3.9.4 Assumptions for Microbiology Susceptibility (MS) Domain Model
      • 6.3.9.5 Examples for MB and MS Domain Models
    • 6.3.10 Pharmacokinetics Domains — PC and PP
      • 6.3.10.1 Assumptions for Pharmacokinetic Concentrations (PC) Domain Model
      • 6.3.10.2 Examples for Pharmacokinetic Concentrations (PC) Domain Model
      • 6.3.10.3 Assumptions for Pharmacokinetic Parameters (PP) Domain Model
      • 6.3.10.4 Example for Pharmacokinetic Parameters (PP) Domain Model
      • 6.3.10.5 Relating PP Records to PC Records
        • 6.3.10.5.1 Relating Datasets
        • 6.3.10.5.2 Relating Records
      • 6.3.10.6 Conclusions
      • 6.3.10.7 Suggestions for Implementing RELREC in the Submission of PK Data
  • 6.4 Findings about Events or Interventions
    • 6.4.1 When to Use Findings About
    • 6.4.2 Naming Findings About Domains
    • 6.4.3 Variables Unique to Findings About
    • 6.4.4 Findings About (FA) Domain Model
    • 6.4.5 Assumptions for Findings About Domain Model
    • 6.4.6 Findings About Examples
• 7 Trial Design Datasets
  • 7.1 Introduction
    • 7.1.1 Purpose of Trial Design Model
    • 7.1.2 Definitions of Trial Design Concepts
    • 7.1.3 Current and Future Contents of the Trial Design Model
  • 7.2 Trial Arms
    • 7.2.1 Trial Arms Dataset — TA
    • 7.2.2 Assumptions for TA Dataset
    • 7.2.3 Trial Arms Examples
      • 7.2.3.1 Example Trial 1, a Parallel Trial
      • 7.2.3.2 Example Trial 2, a Crossover Trial
      • 7.2.3.3 Example Trial 3, a Trial with Multiple Branch Points
      • 7.2.3.4 Example Trial 4, Cycles of Chemotherapy
      • 7.2.3.5 Example Trial 5, Cycles with Different Treatment Durations
      • 7.2.3.6 Example Trial 6, Chemotherapy Trial with Cycles of Different Lengths
      • 7.2.3.7 Example Trial 7, Trial with Disparate Arms
    • 7.2.4 Issues in Trial Arms Datasets
      • 7.2.4.1 Distinguishing between Branches and Transitions
      • 7.2.4.2 Subjects not Assigned to an Arm
      • 7.2.4.3 Defining Epochs
      • 7.2.4.4 Rule Variables
  • 7.3 Trial Elements
    • 7.3.1 Trial Elements Dataset — TE
    • 7.3.2 Assumptions for TE Dataset
    • 7.3.3 Trial Elements Examples
    • 7.3.4 Trial Elements Issues
      • 7.3.4.1 Granularity of Trial Elements
      • 7.3.4.2 Distinguishing Elements, Study Cells, and Epochs
      • 7.3.4.3 Transitions between Elements
  • 7.4 Trial Visits
    • 7.4.1 Trial Visits Dataset — TV
    • 7.4.2 Assumptions for TV Dataset
    • 7.4.3 Trial Visits Examples
    • 7.4.4 Trial Visits Issues
      • 7.4.4.1 Identifying Trial Visits
      • 7.4.4.2 Trial Visit Rules
      • 7.4.4.3 Visit Schedules Expressed with Ranges
      • 7.4.4.4 Contingent Visits
  • 7.5 Trial Inclusion/Exclusion Criteria
    • 7.5.1 Trial Inclusion/Exclusion Criteria Dataset — TI
    • 7.5.2 Assumptions for TI Dataset
    • 7.5.3 Examples for Trial Inclusion/Exclusion Dataset Model
  • 7.6 Trial Summary Information
    • 7.6.1 Trial Summary Dataset — TS
    • 7.6.2 Assumptions for Trial Summary Dataset Model
    • 7.6.3 Examples for Trial Summary Dataset Model
  • 7.7 How to Model the Design of a Clinical Trial
• 8 Representing Relationships and Data
  • 8.1 Relating Groups of Records within a Domain Using the --GRPID Variable
    • 8.1.1 --GRPID Example
  • 8.2 Relating Peer Records
    • 8.2.1 RELREC Dataset
    • 8.2.2 RELREC Dataset Examples
  • 8.3 Relating Datasets
    • 8.3.1 RELREC Dataset Relationship Example
  • 8.4 Relating Non-Standard Variables Values to a Parent Domain
    • 8.4.1 Supplemental Qualifiers: SUPPQUAL or SUPP-- Datasets
    • 8.4.2 Submitting Supplemental Qualifiers in Separate Datasets
    • 8.4.3 SUPP-- Examples
    • 8.4.4 When Not to Use Supplemental Qualifiers
  • 8.5 Relating Comments to a Parent Domain
  • 8.6 How to Determine Where Data Belong in the SDTM
    • 8.6.1 Guidelines for Determining the General Observation Class
    • 8.6.2 Guidelines for Forming New Domains
    • 8.6.3 Guidelines for Differentiating between Events, Findings, and Findings about Events
• Appendices
  • Appendix A: CDISC SDS Team *
  • Appendix B: Glossary and Abbreviations
  • Appendix C: Controlled Terminology
    • Appendix C1: Controlled Terms or Format for SDTM Variables (see also 1437HAppendix C3: Trial Summary Codes)
    • Appendix C2: Reserved Domain Codes
    • Appendix C2a: Reserved Domain Codes under Discussion
    • Appendix C3: Trial Summary Codes
    • Appendix C4: Drug Accountability Test Codes
    • Appendix C5: Supplemental Qualifiers Name Codes
  • Appendix D: CDISC Variable-Naming Fragments
  • Appendix E: Revision History
  • Appendix F: Representations and Warranties, Limitations of Liability, and Disclaimers