Study Data Tabulation Model Implementation Guide: Human ...

1 Study Data Tabulation Model Implementation guide : Human Clinical Trials Ve r s i o n (Final) Prepared by the CDISC Submission Data Standards Team Revision History Date Version 2018-11-20 Final 2013-11-26 Final 2012-07-16 Final 2008-11-12 Final 2005-08-26 Final 2004-07-14 See Appendix F f or Representations and Warranties, Limitations of Liability, and Disclaimers. Notes to Readers This is the Implementation guide for Human clinical trials corresponding to Version of the CDISC Study Data Tabulation Model . CDISC Study Data Tabulation Model Implementation guide : Human Clinical Trials (Version Final) 2018 Clinical Data Interchange Standards Consortium, Inc.

2 All rights reserved Page 2 2018-11-20 CONTENTS 1 INTRODUCTION .. 7 PURPOSE .. 7 ORGANIZATION OF THIS DOCUMENT .. 7 RELATIONSHIP TO PRIOR CDISC DOCUMENTS .. 7 HOW TO READ THIS Implementation guide .. 8 How to Read a Domain Specification .. 9 2 FUNDAMENTALS OF THE SDTM .. 11 OBSERVATIONS AND VARIABLES .. 11 DATASETS AND DOMAINS .. 11 THE GENERAL OBSERVATION CLASS .. 12 DATASETS OTHER THAN GENERAL OBSERVATION .. 12 THE SDTM STANDARD DOMAIN MODELS .. 13 CREATING A NEW DOMAIN .. 14 SDTM VARIABLES NOT ALLOWED IN 15 3 SUBMITTING DATA IN STANDARD FORMAT .. 17 STANDARD METADATA FOR DATASET CONTENTS AND ATTRIBUTES.

3 17 USING THE CDISC DOMAIN MODELS IN REGULATORY SUBMISSIONS DATASET METADATA 17 Dataset-Level Metadata .. 17 Primary Keys .. 21 CDISC Submission Value-Level Metadata .. 21 Conformance .. 21 4 ASSUMPTIONS FOR DOMAIN MODELS .. 23 GENERAL DOMAIN ASSUMPTIONS .. 23 Review Study Data Tabulation and Implementation guide .. 23 Relationship to Analysis Datasets .. 23 Additional Timing Variables .. 23 EPOCH Variable Guidance .. 23 Order of the Variables .. 23 SDTM Core Designations .. 23 Additional Guidance on Dataset Naming .. 24 Splitting Domains .. 24 Trial Inclusion/Exclusion Criteria.

4 26 Origin Metadata .. 27 Origin Metadata for Variables .. 27 Origin Metadata for Records .. 27 Assigning Natural Keys in the Metadata .. 27 GENERAL VARIABLE ASSUMPTIONS .. 29 Variable-Naming Conventions .. 29 Two-Character Domain Identifier .. 29 Use of Subject and USUBJID .. 30 Text Case in Submitted Data .. 30 CDISC Study Data Tabulation Model Implementation guide : Human Clinical Trials (Version Final) 2018 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 3 2018-11-20 Convention for Missing Values .. 31 Grouping Variables and Categorization .. 31 Submitting Free Text from the CRF.

5 32 "Specify" Values for Non-Result Qualifier 32 "Specify" Values for Result Qualifier Variables .. 34 "Specify" Values for Topic Variables .. 34 Multiple Values for a Variable .. 35 Multiple Values for an Intervention or Event Topic Variable .. 35 Multiple Values for a Findings Result Variable .. 35 Multiple Values for a Non-Result Qualifier Variable .. 36 Variable Lengths .. 37 CODING AND CONTROLLED TERMINOLOGY ASSUMPTIONS .. 37 Types of Controlled Terminology .. 37 Controlled Terminology Text Case .. 37 Controlled Terminology Values .. 37 Use of Controlled Terminology and Arbitrary Number Codes.

6 38 Storing Controlled Terminology for Synonym Qualifier Variables .. 38 Storing Topic Variables for General Domain Models .. 38 Use of "Yes" and "No" Values .. 38 ACTUAL AND RELATIVE TIME ASSUMPTIONS .. 39 Formats for Date/Time Variables .. 39 Date/Time Precision .. 40 Intervals of Time and Use of Duration for --DUR Variables .. 41 Intervals of Time and Use of Duration .. 41 Interval with Uncertainty .. 42 Use of the " Study Day" Variables .. 42 Clinical Encounters and Visits .. 43 Representing Additional Study Days .. 43 Use of Relative Timing Variables .. 44 Date and Time Reported in a Domain Based on Findings.

7 46 Use of Dates as Result Variables .. 47 Representing Time Points .. 47 Disease Milestones and Disease Milestone Timing Variables .. 50 OTHER ASSUMPTIONS .. 52 Original and Standardized Results of Findings and Tests Not Done .. 52 Original and Standardized Results .. 52 Tests Not Done .. 53 Examples of Original and Standard Units and Test Not Done .. 54 Linking of Multiple Observations .. 56 Text Strings That Exceed the Maximum Length for General-Observation-Class Domain Variables .. 56 Test Name (--TEST) Greater than 40 Characters .. 56 Text Strings Greater than 200 Characters in Other Variables.

8 56 Evaluators in the Interventions and Events Observation Classes .. 58 Clinical Significance for Findings Observation Class Data .. 59 Supplemental Reason Variables .. 59 CDISC Study Data Tabulation Model Implementation guide : Human Clinical Trials (Version Final) 2018 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 4 2018-11-20 Presence or Absence of Pre-Specified Interventions and Events .. 60 Accounting for Long-Term Follow-up .. 60 Baseline Values .. 61 5 MODELS FOR SPECIAL PURPOSE DOMAINS .. 62 COMMENTS .. 62 DEMOGRAPHICS .. 64 SUBJECT ELEMENTS.

9 74 SUBJECT DISEASE 80 SUBJECT VISITS .. 82 6 DOMAIN MODELS BASED ON THE GENERAL OBSERVATION CLASSES .. 86 MODELS FOR INTERVENTIONS DOMAINS .. 86 Procedure Agents .. 86 Concomitant and Prior Medications .. 92 Exposure Domains .. 98 Exposure .. 98 Exposure as Collected .. 101 Exposure/Exposure as Collected Examples .. 106 Meal Data .. 119 Procedures .. 123 Substance Use .. 127 MODELS FOR EVENTS DOMAINS .. 132 Adverse Events .. 132 Clinical Events .. 140 Disposition .. 144 Protocol Deviations .. 158 Healthcare Encounters .. 160 Medical History .. 165 MODELS FOR FINDINGS DOMAINS.

10 172 Drug Accountability .. 173 Death Details .. 177 ECG Test Results .. 180 Inclusion/Exclusion Criteria Not Met .. 188 Immunogenicity Specimen Assessments .. 191 Laboratory Test Results .. 194 Microbiology Domains .. 200 Microbiology Specimen .. 200 Microbiology Susceptibility .. 204 Microbiology Specimen/Microbiology Susceptibility Examples .. 210 Microscopic Findings .. 218 Morphology .. 223 Morphology/Physiology Domains .. 230 Generic Morphology/Physiology Specification .. 230 Cardiovascular System Findings .. 231 Musculoskeletal System Findings .. 235 Nervous System Findings.