Course Title:

SDTM Theory & Application

Prerequisites:

A basic understanding of relational database design is helpful but not required.

Brief Description:

The SDTM (Study Data Tabulation Model) is a specification in the FDA eCTD Guidance as the model for submitting clinical and preclinical data to the FDA in support of marketing applications. This class consists of 1) a detailed review of SDTM concepts, SDTM domain models, and relationship tables, 2) a discussion of common implementation issues, and 3) a workshop with CRF-annotation exercises that reinforce attendees' understanding of the SDTM and the SDTM Implementation Guide.

Attendees Will Learn:

1) The theory behind SDTM and the format of data that will be required for submission to the FDA.

2) Key SDTM concepts.

3) How to represent various types of collected data in the SDTM format.

 Audience:

Standards Managers, Data Managers, Statisticians, Programmers, and others involved in the creation or submission of data. This course is also intended for those within regulatory agencies who will use or process data in this format.