Module 1: SDTM On-Demand Training
Overview & SDTM-related Resources
© 2025 CDISC
SDTM On-Demand Training Modules
© 2025 CDISC
<ANIM1> The CDISC SDTM OnDemand training modules provide an introduction to and
understanding of SDTM and the SDTM Implementation Guide for Human Clinical Trials.
<ANIM2> It also covers the fundamental concepts underlying the standards,
demonstrates how to apply those concepts in the creation of SDTMIG datasets,
<ANIM3> discusses the relationship to and primary expectations of regulators who
review SDTMIG data,
<ANIM4> and the place of SDTMIG data in the continuum of CDISC standards from
protocol to analysis.
This training is designed to be thorough and accessible, providing you with the
knowledge and skills necessary to confidently navigate the world of SDTM. We
encourage you to engage with each module, take your time, and embrace the learning
process.
SDTM On-Demand Training Modules
Introduction to SDTM and SDTM
Implementation Guide (IG)
Applying those concepts to the
SDTMIG
Expectations of SDTMIG data
regulators
SDTMIG data in CDISC standards
from protocol to analysis
© 2025 CDISC
<ANIM1> The CDISC SDTM OnDemand training modules provide an introduction to and
understanding of SDTM and the SDTM Implementation Guide for Human Clinical Trials.
<ANIM2> It also covers the fundamental concepts underlying the standards,
demonstrates how to apply those concepts in the creation of SDTMIG datasets,
<ANIM3> discusses the relationship to and primary expectations of regulators who
review SDTMIG data,
<ANIM4> and the place of SDTMIG data in the continuum of CDISC standards from
protocol to analysis.
This training is designed to be thorough and accessible, providing you with the
knowledge and skills necessary to confidently navigate the world of SDTM. We
encourage you to engage with each module, take your time, and embrace the learning
process.
SDTM On-Demand Training Modules
Introduction to SDTM and SDTM
Implementation Guide (IG)
Applying those concepts to the
SDTMIG
Expectations of SDTMIG data
regulators
SDTMIG data in CDISC standards
from protocol to analysis
© 2025 CDISC
<ANIM1> The CDISC SDTM OnDemand training modules provide an introduction to and
understanding of SDTM and the SDTM Implementation Guide for Human Clinical Trials.
<ANIM2> It also covers the fundamental concepts underlying the standards,
demonstrates how to apply those concepts in the creation of SDTMIG datasets,
<ANIM3> discusses the relationship to and primary expectations of regulators who
review SDTMIG data,
<ANIM4> and the place of SDTMIG data in the continuum of CDISC standards from
protocol to analysis.
This training is designed to be thorough and accessible, providing you with the
knowledge and skills necessary to confidently navigate the world of SDTM. We
encourage you to engage with each module, take your time, and embrace the learning
process.
SDTM On-Demand Training Modules
Introduction to SDTM and SDTM
Implementation Guide (IG)
Applying those concepts to the
SDTMIG
Expectations of SDTMIG data
regulators
SDTMIG data in CDISC standards
from protocol to analysis
© 2025 CDISC
<ANIM1> The CDISC SDTM OnDemand training modules provide an introduction to and
understanding of SDTM and the SDTM Implementation Guide for Human Clinical Trials.
<ANIM2> It also covers the fundamental concepts underlying the standards,
demonstrates how to apply those concepts in the creation of SDTMIG datasets,
<ANIM3> discusses the relationship to and primary expectations of regulators who
review SDTMIG data,
<ANIM4> and the place of SDTMIG data in the continuum of CDISC standards from
protocol to analysis.
This training is designed to be thorough and accessible, providing you with the
knowledge and skills necessary to confidently navigate the world of SDTM. We
encourage you to engage with each module, take your time, and embrace the learning
process.
SDTM On-Demand Training Modules
Introduction to SDTM and SDTM
Implementation Guide (IG)
Applying those concepts to the
SDTMIG
Expectations of SDTMIG data
regulators
SDTMIG data in CDISC standards
from protocol to analysis
© 2025 CDISC
<ANIM1> The CDISC SDTM OnDemand training modules provide an introduction to and
understanding of SDTM and the SDTM Implementation Guide for Human Clinical Trials.
<ANIM2> It also covers the fundamental concepts underlying the standards,
demonstrates how to apply those concepts in the creation of SDTMIG datasets,
<ANIM3> discusses the relationship to and primary expectations of regulators who
review SDTMIG data,
<ANIM4> and the place of SDTMIG data in the continuum of CDISC standards from
protocol to analysis.
This training is designed to be thorough and accessible, providing you with the
knowledge and skills necessary to confidently navigate the world of SDTM. We
encourage you to engage with each module, take your time, and embrace the learning
process.
Accessing SDTM Documentation
© 2025 CDISC
Now that we've outlined the structure of this training, let's discuss how to access the
essential S-D-T-M documentation and resources. As you are accessing this training
through the C-DISC website, you already have direct access to all the standards and
resources housed on [Link].
[Link]
© 2025 CDISC
To view the SDTM standards, navigate to the Foundational Standards area of the
website. Here, you'll find links to both the SDTM Model and the SDTM Implementation
Guide.
SDTM Model and SDTMIG
© 2025 CDISC
<ANIM1> The SDTM model provides a standard template for organizing and formatting
data for human and animal studies.
<ANIM2> The SDTMIG is intended to guide the organization, structure, and format of
standard clinical trial tabulation datasets.
SDTM Model and SDTMIG
SDTM Model
Provides template for organizing
and formatting study data
© 2025 CDISC
<ANIM1> The SDTM model provides a standard template for organizing and formatting
data for human and animal studies.
<ANIM2> The SDTMIG is intended to guide the organization, structure, and format of
standard clinical trial tabulation datasets.
SDTM Model and SDTMIG
SDTM Model SDTMIG
Provides template for organizing Guides the organization, structure,
and formatting study data and format of tabulation datasets
© 2025 CDISC
<ANIM1> The SDTM model provides a standard template for organizing and formatting
data for human and animal studies.
<ANIM2> The SDTMIG is intended to guide the organization, structure, and format of
standard clinical trial tabulation datasets.
Accessing CDISC Controlled Terminology (CT)
© 2025 CDISC
In addition to the SDTM documentation, you'll also need to access CDISC Controlled
Terminology, or C-T, which is the set of codelists and valid values used with data items
within CDISC-defined datasets, including SDTM. To find it, navigate to the 'Terminology'
area of the CDISC website, where you'll find a page with links to download the controlled
terminology.
CDISC Controlled Terminology Page
© 2025 CDISC
CDISC, in collaboration with the National Cancer Institute's Enterprise Vocabulary
Services (NCI-EVS), supports the Controlled Terminology needs of CDISC Foundational
and Therapeutic Area Standards.
<ANIM1>You can access the Controlled Terminology documents on the NCI-EVS site.
CDISC Therapeutic Area (TA) User Guides
© 2025 CDISC
Finally, SDTM-related content is also available in CDISC Therapeutic Area, or TA, User
Guides. These guides focus on specific therapeutic areas and provide invaluable insights
into how SDTM is applied in those contexts.
<ANIM1> Several User Guides are available on the CDISC website.
CDISC Library
© 2025 CDISC
In addition to these direct links, you can also access all CDISC standards, including SDTM,
through the CDISC Library, also available on the CDISC website. The library provides a
centralized location for searching and accessing all CDISC standards.
Your SDTM Learning Toolkit
CDISC SDTM On-Demand Trainings
SDTM
SDTMIG
Controlled Terminology
Therapeutic Area User Guides
CDISC Library
© 2025 CDISC
We invite you to access, download and familiarize yourself with these resources before
you start the training, so you'll be well-equipped to navigate the concepts outlined in the
CDISC SDTM On-Demand Training Modules.
From all of us at CDISC, we wish you good luck on your SDTM learning journey.