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.
SDTM 1.4-1.7, SDTMIG 3.2-3.3
Familiarity with SDTM v1.4 and SDTMIG v3.2
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
Academic Institution, BioTech, Clinical Laboratory, Consulting, CRO, Government, Healthcare Provider, Medical Device, NPO, Pharmaceutical, Technology Service Provider, Other