A Barnett Interactive Web Seminar offers you a seamless, secure, multimedia learning experience. These live, instructor-led sessions are designed to be highly interactive, and can be attended by individual attendees or groups at one low cost. No travel, no travel expenses, and no time away from the office!

SDTM and CDASH: What’s the Connection?

Upcoming Courses

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.

Learning Objectives

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

Who Should Attend

Clinical Data Managers
Clinical/Statistical Programmers
Statisticians

Instructor

Denise G. Redkar-Brown, MT

Click here for complete trainer biographies

Registration Fees

$735

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-17-093-L01-P. Released: 11/17.

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