SDTM Bundle

You are now enrolled in the SDTM Bundle. The modules included in the SDTM Bundle are linked below. They are also available in the navigation bar on the left:

• SDTM001: An Introduction to the Study Data Tabulation Model

• SDTM002: SDTM Basics

• SDTM003: Basics of the SDTM Implementation Guide

• SDTM004: Special Purpose Domains: Demographics

• SDTM005: General Observation Classes

• SDTM006: Timing and Grouping Variables

• SDTM007: Controlled Terminology

• SDTM008: Interventions Domains

• SDTM009: Events Domains

• SDTM010: Findings Domains

• SDTM011: Findings About

• SDTM012: RELREC - Relating Records and Datasets in SDTM

• SDTM013: Supplemental Qualifiers

• SDTM014: Creating Custom Domains

• SDTM015: Trial Design

• SDTM016: Special Purpose Domains

• SDTM017: Define-XML

• SDTM018: New Interventions Domains in SDTMIG v3.2

• SDTM019: New Events Domains in SDTMIG v3.2

Once you have completed all training modules, please email onlinetrainingsupport@cdisc.org to receive a Certificate of Achievement for the SDTM Bundle.

SDTM001

Learning Outcomes:

Explain the purpose of the CDISC Standards and SDTM

Locate and access the documentation for the current versions of SDTM-related documents

SDTM Module 1 is a FREE On-Demand module. Log into your learning account to access this training.

Language: English | Video Duration: 18:12 | CEUs: 0.1

SDTM002

Learning Outcomes:

• List the roles and correct order of SDTM variables

• Describe the basic data structures in SDTM

Language: English | Video Duration: 15:07| CEUs: 0.1

SDTM003

Learning Outcomes:

• Navigate the Implementation Guide Sections of the SDTMIG

• Demonstrate working knowledge of the Domain Table and Domain Assumptions and Examples in the SDTMIG

Language: English | Video Duration: 13:17 | CEUs: 0.1

SDTM004

Learning Outcomes:

• Describe the purpose and contents of the Demographics Domain in SDTM datasets

• Identify variables in the Demographics Domain

• Correctly assemble multiple entries for standard Demographics variables in an SDTM dataset

Language: English | Video Duration: 11:56| CEUs: 0.1

SDTM005

Learning Outcomes:

• General Observation Classes and the variable types of Identifier and Timing

• General Observation Classes – Topic variables

• General Observation Classes – Qualifier variables

• Introduction to Relationship and Trial Design Domains

Language: English | Video Duration: 22:42| CEUs: 0.1

SDTM006

Learning Outcomes:

• Correctly use times variables to store dates and other time-related data in SDTM datasets

• Format SDTM timing variables correctly and use relative timing variables where appropriate

Language: English | Video Duration: 49:39| CEUs: 0.1

SDTM007

Learning Outcomes:

• Deescribe how controlled terminology is used in SDTM datasets

• Locate references to controlled terms in the SDTM and SDTM IG documents

• Locate and implement SDTM controlled terminology file

Language: English | Video Duration: 24:00| CEUs: 0.1

SDTM008

Learning Outcomes:

• Successfully identify variables included in the Interventions General Observation Class

• Accurately explain how, when and why the three SDTM Interventions Domains variables are used in SDTM datasets

Language: English | Video Duration: 24:10 | CEUs: 0.1

SDTM009

Learning Outcomes:

• Successfully identify variables included in the Events General Observation Class Domains

• Accurately explain how, when and why the three Events Domains

Language: English | Video Duration: 27:03| CEUs: 0.1

SDTM010

Learning Outcomes:

• Successfully identify variables included in the Findings Domains

• Accurately explain how, when and why the ten Findings Domains

Language: English | Video Duration: 57:14 | CEUs: 0.1

SDTM011

Learning Outcomes:

• Successfully identify variables included in the Findings About Domains

• Accurately explain how, when and why the Findings About Domains

Language: English | Video Duration: 17:39 | CEUs: 0.1

SDTM012

Learning Outcomes:

• Successfully identify variables included in the RELREC dataset

• Correctly use RELREC to show collected relationships between individual records for a subject, and relationships between whole domains in SDTM datasets

Language: English | Video Duration: 13:04| CEUs: 0.1

SDTM013

Learning Outcomes:

• Correctly use Supplemental Qualifiers allow to add non-standard, sponsor-defined variables to our data in an SDTM dataset

• Correctly use Supplemental Qualifiers dataset structure to link to related data, and examples in an SDTM dataset

Language: English | Video Duration: 19:33| CEUs: 0.1

SDTM014

Learning Outcomes:

• Create a custom domain that uses the correct general observation class and correct variables from the SDTM model

Language: English | Video Duration: 13:31| CEUs: 0.1

SDTM015

Learning Outcomes:

• Represent a study design using the trial design datasets

Language: English | Video Duration: 28:25| CEUs: 0.1

SDTM016

Learning Outcomes:

• Design SE and SV domains that reflect the subjects’ participation in the trial

Language: English | Video Duration: 20:15| CEUs: 0.1

SDTM017

Learning Outcomes:

• Identify correct and incorrect characteristics of a simple SDTM define-xml describing datasets, variables and controlled terminology for a study

Language: English | Video Duration: 31:08| CEUs: 0.1

SDTM019

Learning Outcomes:

• Correctly use new SDTMIG v3.2 Events domains to model data

• Select the correct SDTMIG v3.2 events domain for use with select study data domains

• Correctly associate HO data with related AE or other data

Language: English | Video Duration: 24:00| CEUs: 0.1

SDTM020

Learning Outcomes:

• correctly use new SDTMIG v3.2 Events domains to model data
• select the correct SDTMIG v3.2 events domain for use with select study data domains
• correctly associate HO data with related AE or other data

Language: English | Video Duration: 8:05| CEUs: 0.1