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On December 17th, the FDA made its long-awaited announcement: future submissions will be required in standardized format.

“ The Agency may Refuse To File (RTF) for NDAs and BLAs, or Refuse To Receive (RTR) for ANDAs an electronic submission that does not have study data in conformance to the required standards… ”  – FDA Guidance for Industry

This represents a seismic shift for the industry. However, adapting to this new paradigm can be relatively painless — if you have the right guidance.

Through this webinar, we’ll cover the details of the new mandate, what it all means, and the steps you’ll need to take. Our speakers are Dhananjay (DJ) Chhatre (former FDA operations research analyst) and Sergiy Sirichenko (co-founder of OpenCDISC): two industry experts who currently support the FDA’s eDATA team.

For your convenience, we’ll be providing this webinar at two different times.

In this webinar, we will cover:

• Descriptions of the final guidance documents and their contents
• How these new regulations will impact you
• FDA’s timeline for implementation
• How to communicate with the FDA during the process
• Technical implementation of CDISC standards
• Questions & Answers

Best regards.
OpenCDISC Team

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.

We are proud to announce the release of our next generation open source toolkit. Community 2.0 was created just for the CDISC professional and provides a wealth of game-changing new tools, including an upgraded version of Validator, a Define.xml Generator, and more. Download OpenCDISC Community 2.0 here

OpenCDISC Community 2.0 includes the following new features:

• Validator – upgraded with FDA validation rules and ability to validate against study specific value level metadata
• Define.xml Generator – creates fully compliant Define.xml 2.0 for SDTM, SEND, and ADaM datasets
• Data Converter – quickly converts data between SAS XPORT, Dataset-XML, Excel, and CSV formats
• ClinicalTrials.gov​ Miner – aggregates clinical outcome measures/endpoints across trials and therapeutic areas

This morning, November 18th, the Food and Drug Administration (FDA) published its first official list of validation rules for CDISC SDTM. These long awaited rules cover both conformance and quality requirements, as described in the FDA Study Data Technical Conformance Guide. Conformance validation rules help ensure that the data conform to the standards, while quality checks help ensure the data support meaningful analysis.

The FDA is asking sponsors to validate their study data before submission using these published validation rules and either correct any validation issues or explain, why they could not be corrected, in the Study Data Reviewer's Guide. This recommended pre-submission validation step is intended to minimize the presence of validation issues at the time of submission.

Rest assured: we have implemented the new FDA validation rules in the upcoming OpenCDISC Community 2.0 — keeping you ahead of the curve. Please join Sergiy Sirichenko — co-founder of OpenCDISC and an FDA Data Fitness Analyst — to learn about the new FDA validation rules and how you can get compliant in time for your next submission.

On October 9, 2014, the Pinnacle 21 tour bus rolled over the Golden Gate Bridge and into Foster City, where we held our third OpenCDISC Live event. And what an event it was.

We kicked off with a brief history of OpenCDISC, where Max Kanevsky, Pinnacle 21 president and CEO, talked about the origins of the project and how it has evolved over years. Attendees then received tutorials on two FDA programs — JumpStart and DataFit — and learned why both are so critical to the modern FDA review process.

The second stop on the OpenCDISC Live 2014 Tour, in East Hanover, NJ, was a lively and engaging event, and we thank everyone who attended.

In addition to providing tutorials on two FDA programs — JumpStart and DataFit — our subject matter experts covered how to create FDA-compliant Define.xml 2.0 files. Attendees also got a sneak peek of OpenCDISC Community v2.0, the next-generation of our gold-standard open-source software.

OpenCDISC Live is making its way to the San Francisco Bay Area for the West Coast swing of our 2014 tour!
Enjoy this opportunity to meet the creators of OpenCDISC face-to-face, ask questions, collaborate and learn.

In our first West Coast Forum, we'll be discussing how to prepare for the new FDA JumpStart and DataFit processes.
We'll also give you an in-depth look at OpenCDISC Enterprise and show you how its new advancements can assist
the process.

OpenCDISC Live is making its way to North Jersey for the second stop on
our 2014 tour!

Our first OpenCDISC Live event — in Boston, earlier this summer — drew more than 100 attendees, and a wealth of thoughtful discussions around JumpStart, DataFit, and the modern FDA approval process.

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.

There has been a lot of buzz about DataFit of late. The FDA announced it as a new project that will enable the organization to “effectively leverage standard data to advance the review process.” But this new project is more than ten years in the making.