SDTM for Medical Devices (ON-DEMAND)

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. 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 course is intended for individuals who are already familiar with SDTM and wish to learn how to represent device-specific data in SDTM structures. It is based on the SDTM Implementation Guide for Medical Devices, and covers the relationship of the Med Dev IG to the other IGs, the overall assumptions in the IG, and the 7 device domains. Its examples and use cases are drawn from devices used in humans, particularly implantable devices such as pacemakers. The information is applicable to most kinds of devices, with the exception of in vitro diagnostics and other device studies that generally do not included subject data. 

This is the “Abbreviated” SDTM for Medical Devices in Humans training, meaning that it focuses on the SDTM IG for Medical Devices, and does not cover general principles or structures also used in non-device studies. It is intended for people who are familiar with SDTM. 

The On-Demand format is a self-paced training.

Total video duration: 70 minutes

Estimated activity time: 45 minutes