Controlled Terminology
Course Description (1/2-day course)
The Study Data Tabulation Model (SDTM) is a specification for the submission of pre-clinical, clinical and device data to the U.S. Food and Drug Administration in support of marketing applications. The SDTM Implementation Guide for Medical Devices (SDTMIG-MD) is used in conjunction with the SDTM and SDTMIG for Human Clinical Trials to support medical device submissions.
This course combines instruction on using the SDTM IG for Human Clinical Trials (the foundational SDTMIG) and device-specific domains and practices. It uses device-based examples to illustrate the key principles of the SDTM model and implementation guide, and covers the device domains in detail. Device-specific implementations of some core domain, such as AEs, are also included.
Topics covered in the two-day SDTM for Medical Devices course focus on subject-related data and device data, and include:
- SDTM Model
- Demographics Model
- General Observation Classes - Model
- Timing and Grouping
- Creating Custom Domains
- General Observation Classes - Implemented
- Findings About
- Relationships
- Device-specific Domains
You may also be interested in
Declare Interest
You will be added to the interest list for .
Declare Interest
Please enter a valid value for quantity.
By selecting the installment terms, you agree to pay your first installment during checkout and then to pay installments of US $ per month beginning .
Change Payment Plan
Please remove this course from the cart to select a different payment plan.
