In collaboration with c4c, CDISC is developing a Paediatrics User Guide, which builds on existing CDISC data standards, and will consist of data collection and data tabulation examples for cross-cutting paediatric data items used in clinical trials. The draft version 1.0 of the Paediatrics User Guide is now entering public review. Below you can find links to review the Paediatrics User Guide and instructions on how you can provide comments:


A webinar will take place on 12th July between 17:00-18:30 CEST to provide more information about the public review. You can register to attend the webinar here.


The public review phase will close on 25th July 2022. Anyone with an interest in paediatric research including academics, industry, patients, parents can provide comments during the public review. In order to provide comments, you will need to log in or register for the CDISC Wiki here.


The public review is a key quality step in the CDISC data standards development process. CDISC relies on reviewers input to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community interested in improving research processes and quality for the benefit of all. The development of the Paediatric User Guide is an important milestone for c4c and will support the harmonization of paediatric data on a global scale.