Course Description

Currently, the FDA requires that clinical trial data be electronically submitted in the Clinical Data Interchange Standards Consortium (CDISC) format for consideration for a new drug/biological approval. A significant element in this submission is the Study Data Tabulation Model (SDTM). This web seminar will examine the information defining the concepts of the SDTM as presented in the documentation Version 1.4. The purpose of data standards, benefits of applying these standards, and the relationship between datasets and records will be examined. The relationship between the standard for data collection instruments — also known as Clinical Data Acquisition Standards Harmonization (CDASH) standards — and the standard data format in which the data will be presented will also be discussed.

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Learning Objectives

• Review SDTM concepts and terms
• Discuss Model fundamentals
• Demonstrate the Trial Design Model
• Identify relationships among datasets and records
• Examine Model fundamentals application to Associated Persons
• Describe the connection between CDASH and CDISC for data capture

Who Should Attend

• Clinical Data Managers
• Clinical/Statistical Programmers
• Statisticians

Instructor

The course will be led by one of the following instructors:

Denise G. Redkar-Brown, MT

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.