November was an important month for people who deal with clinical research data and metadata. First, the FDA published new, official validation rules for SDTM. Second, Pinnacle 21 released the next generation of its renowned open source toolkit: OpenCDISC Community 2.0.

In the webinars that took place on December 11 and 16, we covered how the latter can provide enormous help in dealing with the former. Community 2.0 comes with a wealth of game-changing new tools — including an upgraded version of Validator, a Define.xml Generator, a Data Converter, and a Clinicaltrials.gov Miner — to help you address these new FDA rules, as well as issues around CDISC compliance and submission readiness.

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