Course Description
The Study Data Tabulation Model (SDTM) and associated Implementation Guides are intended to guide the organization, structure, and format of standard human, animal and medical device trial tabulation datasets. Tabulation datasets are electronic listings of individual observations from a study that comprise the essential data reported from a study. Where required, they form part of regulatory submissions for new products, for example, drug submissions in the US and Japan. They are also a critical part of supporting the interoperability of data from pre-clinical, clinical, device and other related studies, thereby enabling the reuse of data in multiple venues.
This two-day 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 annotating CRFs and creating datasets that reinforce attendees' understanding of the SDTM and the SDTM Implementation Guide for human clinical data
When delivered in the classroom, this is a 2 day course. Delivered virtually, it consists of five 3.5-hour sessions over five days.
Learning Outcomes
At the end of this course, you will be able to:
- Describe the SDTM model and implementation guide, the relationships between them and their relationships to other CDISC standards
- Use the SDTM model, implementation guide and controlled terminology to create SDTM-conformant datasets for a study
- Model custom variables and domains using the model, implementation guide and controlled terminology
Continuing Education Units (CEUs)
Learners will receive 1.6 CEUs for successfully completing this course.
Successful Course Completion
- In order for a learner to successfully complete a course:
- An education representative or learner will complete training registration.
- A learner must attend course for 80% of total course time. Specific attendance requirements are posted in course information pages.
- A learner will complete final course assessment with a score of at least 80% correct.
- A learner will complete summative assessment surveys
- Remediation: The following requirements will be in effect if learner does not successfully complete all parts of training:
- If learner registers for course but fails to complete formative assessment in required time, learner will be notified that they must transfer registration to later date.
- If learner completes formative assessment but does not meet attendance requirement, learner will be notified that they must re-attend course in full.
- If learner meets attendance requirement in full but fails content assessment, learner is given a maximum of two additional re-attempts before being required to re-attend the course in full. Learner will be notified and will receive a certificate of attendance after the third failed assessment attempt.
- If learner successfully completes content assessment but fails to complete summative assessment, learner will be notified and CEUs will be on hold until summative assessment is completed.
Course Type
Blended
Private
Public
Virtual Classroom
Course Length
2 Days
Audience
Biostatistician
CRF Designer
Data Manager
Programmer
Industry
Academic Institution
BioTech
Clinical Laboratory
Consulting
CRO
Government
Healthcare Provider
Medical Device
NPO
Pharmaceutical
Technology Service Provider