Events

From CDASH to SDTM Data Sets - Putting CDISC Standards to Work for You!

Purchase Webinar

This webinar is presented in collaboration with CDISC.
CDISC

This 2 part webinar series will focus on the Clinical Data Acquisition Standards Harmonization (CDASH) data collection standard and how it maps to the Study Data Tabulation Model (SDTM), which is the recommended format for submissions to the FDA. The first webinar will cover the CDASH basics; assumptions, designations, controlled terminology and how use of the CDASH standard will optimize data collection from both the Site and Sponsor perspectives. The second webinar will focus on getting from collection to the SDTM data sets efficiently. This webinar series is designed to show how these standards relate and work together and each part will conclude with a Q & A session.

Webinar #1

CDASH – Standardized CRFs

This webinar will focus on how CDASH can optimize and streamline data collection while at the same time ensuring that the collected data maps into the SDTM. This webinar will provide a brief history of CDASH project, the key assumptions and survey a few domains with a focus on innovative approaches. The CDASH CRF "questions" will be accompanied by the Terminology "answers"; attendees will be informed how these 2 projects relate and where CDISC Controlled terminology can be assessed.

Speakers:
Rhonda Facile
Shannon Labout
Melissa Binz

Webinar #2

Mapping from CDASH to Submission (SDTM) Data Sets

This new webinar will focus on how to map the collected data to the SDTM. Speakers will include a brief history of the development of the SDTM standard, a discussion of the regulatory drivers towards implementation, a review of a few key CDASH domains and how they can be mapped into the SDTM.

Speakers:
Rhonda Facile
Gary Walker

Learning Objectives - Webinar 1

At the conclusion of webinar 1, participants should be able to:

  1. Describe the benefits of CRF standardization for investigative sites and other stakeholders in clinical research.
  2. Explain how CDASH collection fields can be used to create basic CRFs and XML style sheets and how this will facilitate good CRF design and minimize collection of unnecessary data elements and ensure consistency across a clinical program.
  3. Describe how CDASH data collection fields are related to other CDISC standards, specifically the SDTM and CDISC Controlled Terminology.

Learning Objectives - Webinar 2

At the conclusion of webinar 2, participants should be able to:

  1. Describe the history, purpose and approach of the SDTM.
  2. Describe the regulatory drivers for implementing the SDTM.
  3. Map a basic CDASH domain into the SDTM.
  4. Describe the steps necessary to get the SDTM submission data steps.