Presentation Slides CDISC SDTM Dataset Creation

Presentation Slides:
A New Approach to CDISC SDTM
Dataset Creation

The FDA mandate for standardized submissions in both CDISC SDTM and SEND was put in place in December 2016. Now, more than ever, there is a real requirement to optimize the dataset creation process.

In this presentation, CDISC expert Ed Chappell reviews the traditional, laborious method to creating clinical datasets and explores an alternative optimized approach. He also demonstrates how to implement a hybrid approach, combining new, streamlined methods with your existing QA and SAS programming processes, to ultimately get you to submission faster and easier.

Learn about:

  • Regulatory requirements for standardized submissions
  • Traditional dataset creation process, challenges and inefficiencies
  • An optimized approach to standardized dataset creation ready for submission

Discover the time, cost and process efficiencies to be made.

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