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.