OpenCDISC. org — an open source initiative delivering tools for validation of CDISC data

For several years, the FDA has requested that sponsors submit clinical trial data in CDISC SDTM format. Recently, the FDA has begun requiring submissions of other forms of data to be in standardized CDISC formats, for example, CDISC ADaM for analysis data, and CDISC SEND for animal toxicology studies. While commercial tools have been available to validate CDISC SDTM data since the beginning of this standardsadoption process, they have not been freely available to everybody. OpenCDISC. org was initiated in 2008 as an open source community dedicated to the creation of extensible tools for the implementation of CDISC standards, with an initial focus on data validation. The OpenCDISC Validator is built using Java and is configurable so that it can check not only various versions of CDISC data, but can also be tailored to meet the specific needs of a particular submission or a particular setting within a pharmaceutical company. The tool is configured using XML files, which can be modified or created us...