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Setting Up and EDC Study Using CDISC Standards

When setting up an EDC study with CDISC standards, many questions typically arise. The five commonly asked questions below might look familiar:

  1. Why can’t the data simply be collected in SDTM format eliminating the need for CDASH?
  2. What are EDC study best practices when it comes creating a CDISC compliant CRF?
  3. What standard in CDISC has the ANSWERS to the QUESTIONS?
  4. How do I set up a custom CDASH CRF?
  5. What are vertical vs. horizontal datasets?

CDISC standards have completely changed the way data is collected in an EDC study, yet the adoption process can be painstakingly long. By setting up an EDC study using CDISC standards, you will reduce the amount of queries generated, improve data quality and reduce the time to lock your database. Providing a consistent set of CRF questions and responses will also lead to more compliant sites when it comes to entering data, and understanding what is expected of them when collecting their EDC study data.

What questions do you have about setting up EDC studies with CDISC standards?

I’ll be hosting a webinar this afternoon from 2:00 – 3:00pm ET, where I’ll provide insights and answers to the five questions above, and much more. I’ll do my best to address any questions about setting up EDC studies with CDISC standards posted here as well. You can still register for today’s webinar now! Hope you can join me.


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