SDTM Changes and Updates

CDISC provides training on this standard via Blended Learning, Virtual Training and Online Training
Course Description

This course will cover the differences between SDTM standard versions v1.4 to v1.7 and SDTM Implementation Guide version v3.2 to v3.3. Oriented toward clinical implementations, model-related topics include new variables and their expected uses, new datasets and their functions, and the changes to explanatory text.  Implementation guide topics include the implementation of the new model items and discussion of guidance changes.  After taking this course, learners should have the standard-related information needed to assess the impact on their organization.  This course is intended for individuals familiar with SDTM v1.4 and SDTMIG v3.2.

 


Course Length

3 Hours

Course Type

Private
Public

Audience

Biostatistician
Clinician
Concept Modeler
CRF Designer
Data Manager
Medical Writer
Metadata Modeler
Nonclinical Study Personnel
Programmer
Standards Expert
Study Designer
Study Management
System Architect
Technical Manager

Industry

Academic Institution
BioTech
Clinical Laboratory
Consulting
CRO
Government
Healthcare Provider
Medical Device
NPO
Pharmaceutical
Technology Service Provider
Other