On November 19, 2014, the FDA’s Center for Drug Evaluation and Research (CDER) released its new “Validation Rules for Study Data Tabulation Model (SDTM) Formatted Studies.’’ According to CDER, the organization is doing this “to improve the standardization and quality of [submitted] clinical data … as well as to improve the predictability of data quality and usefulness.”

But what does this mean for you? Fortunately, Pinnacle 21 recently hosted a webinar to answer this very question.

The webinar — titled, “FDA Validation Rules: New regulatory requirements and how OpenCDISC can help” — detailed these changes, and provided a tutorial on how you can leverage the latest version of our open source software to execute against these rules.

The FDA continues its push for high-quality data, and a data validation process that can identify issues early in the review — so that they may be corrected before it adversely affects the process, and, by extension, the submission itself.

In the long term, this push will benefit the entire industry. But, in the short term, it is the responsibility of the sponsor to rise to the challenge of providing higher-quality data and conforming to these new standards.

As always, we’re here to help. Below, you’ll find links to the webinar video and PPT deck, as well as the Q&A that followed. Download and review them as you need. If you have any specific questions pertaining to the new FDA rules, don’t hesitate to send us an email.

Webinar Takeaways:

• Watch the webinar video
• Download the webinar slides
• Read the webinar Q&A