The Study Data Tabulation Model (SDTM) is a specification for structuring pre-clinical and clinical data to support interoperable and reusable data sharing, including submissions to the U.S. Food and Drug Administration (FDA) and Japan’s Pharmaceutical and Medical Devices Agency (PMDA) in support of marketing applications.
This course consists of:
• A detailed review of SDTM concepts, SDTM-based domain models for human clinical data, relationship tables, and trial design
• A discussion of common implementation issues
• Exercises including the annotation of CRFs and the creation of datasets that reinforce attendees' understanding of the SDTM and the SDTM Implementation Guide for clinical data
This course roughly covers information in standards documentation as of SDTMv1.7 & SDTMIG v3.3. If there is a disparity of information, please ask the instructor during the training.
Learning Outcomes
At the end of this course, learners will be able to:
Describe the SDTM model and implementation guide and the relationships between them.
Model timing variables correctly for relative, actual, planned and time point data
Identify Findings About candidate data and model them correctly
Construct accurate relationship datasets for non-standard variables and linkages across datasets
Course Agenda
Module 1: Introduction to CDISC
Module 2: SDTM Basics: Model
Module 3: SDTM Basics: Implementation Guide
Module 4: Demographics Model
Module 5: General Observation Classes
Module 6: Timing Variables
Module 7: Creating Custom Domains
Module 8: Interventions and Events Domains
Module 9: Findings and Related Timing
Module 10: Findings About
Module 11: Relationships and Grouping
Module 12: Trial Design
Module 13: Special Purpose Domains
Module 14: Dataset and Variable Metadata
Module 15: Conformance
Module 16: Summary
Continuing Education Units (CEUs)
The learner must receive a score of 80% or higher on the Final Assessment to earn 1.6 CEUs.
Pre-Training Preparation
Please download the documents and watch the following videos prior to the first day of training.
1) Download the latest documents.
2) Watch the Primer Videos.
Introduction Videos:
"What Are SDTM and SDTM Concepts?" (4:16)
"Introduction to SDTM Implementation Guide" (4:29)
Controlled Terminology Video:
"Introduction to Controlled Terminology" (4:03)
Regulatory Requirements Video:
"Introduction to Regulatory Guidance on Standardized Data" (5:32)
3) Watch the Metadata Video.
"Tips for Viewing Metadata" by Gary Walker, CDISC-Authorized Instructor
