SUBMITTING DATA IN STANDARD FORMAT:

• Standard Metadata for Dataset Contents and Attributes
• Using the CDISC Domain Models in Regulatory Submissions - Dataset METADATA
• Primary Keys
• CDISC Submission Value-Level Metadata
• conformance

MODELS FOR SPECIAL-PURPOSE DOMAINS:

• Demographics
• Comments
• Subject Elements
• Subject Visits

DOMAIN MODELS BASED ON THE GENERAL OBSERVATION CLASSES:

• Demographics
• Comments
• Subject Elements
• Subject Visits

DOMAIN MODELS BASED ON THE GENERAL OBSERVATION CLASSES:

• Interventions
• Events
• Findings
• Findings about

TRIAL DESIGN DATA SETS:

• Introduction
• Trial Arms
• Trial Elements
• Trial Visits
• Trial Inclusion/Exclusion Criteria
• Trial Summary Information
• How to Model the Design of a Clinical Trial

REPRESENTING RELATIONSHIPS AND DATA:

• Relating Group of Records Within a Domain Using the Grpid Variable
• Relating Peer Records
• Relating Datasets
• Relating Non-Standard Variables Values to a Parent Domain
• Relating Comments to A Parent Domain
• How to Determine where Data Belong in the SDTM
• Trial Design Datasets
• Representing Relationships And Data
• Models for Special Purpose Domains
• Domain Models Based on General Observation Classes

FUNDAMENTALS OF THE SDTM:

• Observations and Variables
• Datasets and Domains
• Special-Purpose Datasets
• The General Observation Classes
• The SDTM Standard Domain Models
• Creating a New Domain

ASSUMPTIONS FOR DOMAIN MODELS:

GENERAL ASSUMPTIONS FOR ALL DOMAINS:

• General Domain Assumptions
• Review Study Data Tabulation and Implementation Guide
• Relationship to Analysis Datasets
• Additional Timing Variables
• Order of the Variables
• CDISC Core Variables
• Additional Guidance on Dataset Naming
• Splitting Domains
• Origin Metadata
• Assigning Natural Keys in the Metadata

GENERAL VARIABLE ASSUMPTIONS:

• Variable-Naming Conventions
• Two-Character Domain Identifier
• Use of "Subject" and USUBJID
• Case Use of Text in Submitted Data
• Grouping Variables and Categorization
• Submitting Free Text from the CRF
• Multiple Values for a Variable

CODING AND CONTROLLED TERMINOLOGY ASSUMPTIONS:

• Types of Controlled Terminology
• Controlled Terminology Text Case
• Controlled Terminology Values
• Use of Controlled Terminology and Arbitrary Number Codes
• Storing Controlled Terminology for Synonym Qualifier Variables
• Storing Topic Variables for General Domain Models
• Use of "Yes" and "No" Values

ACTUAL AND RELATIVE TIME ASSUMPTIONS:

• Formats for Date/Time Variables
• Intervals of Time and Use of Duration for -DUR Variables
• Use of the "Study Day" Variables
• Clinical Encounters and Visits
• Representing Additional Study Days
• Use of Relative Timing Variables
• Date and Time Reported in a Domain Based on Findings
• Use of Dates as Result Variables
• Representing Time Points