The “Creating Define.xml 2.0 with OpenCDISC” webinars that ran on August 12th and 14th seemed to have served a big need. We had a total of 311 attendees across the two webinars, and received many thoughtful questions.
Bottom line: a lot of you have been struggling with Define.xml, and are excited to have a tool that can create FDA-compliant Define.xml 2.0 files so quickly and assuredly. But, as with any new technological solution, there is a learning process involved.
Rest assured, we’re here to help. We’ll give you the guidance you need to leverage these new tools, and give yourself the best chance at FDA approval.
You can start right here. Below, please find a short list of educational resources from the “Creating Define.xml 2.0 with OpenCDISC” webinar. Review them at your leisure. If you have any specific questions about creating Define.xml 2.0, please feel free to send us an email.