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CDISC Intellectual Property

CDISC retains IP ownership of all of its standards to ensure that CDISC Standards remain open and free, Even when the standards are translated into other languages, the IP belongs to CDISC.


CDISC standards are created through a consensus-based process that includes many different people who contribute their time and expertise. Thus, the value should serve everyone and the IP be protected. Some standards in other industries were developed in a manner that included proprietary portions such that users were charged royalties. The desire to prevent royalty charges or ownership by any one organization or individual formed the basis for the CDISC IP Policy that is now posted on our website.


Proposed DataSci Patent Application: CDISC Standards include metadata standards. It is a sad state of affairs when one company decides that they should patent processes related to metadata. If this patent is approved, it will undermine all of the good will and productive collaboration that the global clinical research industry has contributed over the past 15 years to leverage standards to streamline the way we do research. This will, in turn, have a negative impact on the development of new therapies for patients, all to line the pockets of the leaders of a single company.


The CDISC vision is to improve patient care and safety through higher quality medical research. Open and free standards for clinical research data and metadata are essential to achieve this vision.


Dr. Rebecca Kush

CDISC President and CEO