Whitepaper

The FDA Safety and Innovation Act of 2012. Statute on authorized electronic submissions states that-Beginning not earlier than 24 months after final guidance issued after public notice submissions shall be submitted in such electronic format as specified by the secretary in such guidance. The final guidance was published in December 2014. Thus, all studies that start in the year 2017 or later will be required to submit their data to the FDA in an electronic format i.e.CDISC.

The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC standards are
vendor-neutral, platform-independent and freely available via the CDISC website. CDISC standards are to support the acquisition, exchange, submission and archive of clinical research data and metadata.