About OpenCDISC

OpenCDISC is an open source community focused on building extensible frameworks and tools for the implementation and advancement of CDISC Standards

How it came about

Industry adoption of CDISC has been on the rise with the availability of mature standards, implementation guides, training, and user groups. However, there has been very little help for the developers who are tasked with implementing the standards at their companies. There are currently very few tools, with most being too expensive and limited in functionality, which results in many companies developing custom solutions. CDISC success is largely due to the open, collaborative, and vendor-neutral process by which it was developed. We want to extend this process to the developers.

Community goals

Our primary goal is to provide a collaborative environment where developers, data managers, statisticians, and regulators can jointly discuss, identify, and develop tools for the advancement and implementation of CDISC standards. Our initial project is to develop the CDISC Validator, a tool aimed at ensuring compliance with various CDISC models including SDTM, ADaM, ODM and LAB. Future projects will focus on mapping and integration tools, but ultimately it's up to the community members to determine the direction.


Clinical Data Interchange Standards Consortium, Inc. is not associated with and does not sponsor or endorse Pinnacle 21 LLC or its products or services.