CDISC (Clinical Data Interchange Standards Consortium), in collaboration with the conect4children (c4c) Project, is developing a Paediatrics User Guide (PUG), which builds on existing CDISC standards, and will consist of data collection and data tabulation examples for use in paediatric clinical trials. The use of standards allows data to be more accessible, interoperable and reusable, increasing its value for future research. The c4c project aims to establish a coordinated approach to facilitate the delivery of high-quality regulatory-grade clinical trials in sites across Europe for all paediatric age groups and diseases. c4c is doing this by streamlining clinical trials, facilitating recruitment, educating investigators, and supporting trial design and execution.
A team consisting of CDISC standards experts, paediatric clinical research experts from CDISC member organizations and paediatric subject matter experts from the c4c consortium was formed. Development of the user guide followed a consensus-based, clinical data standards process, consisting of 6 stages:
- Scoping – Identification of development topics.
- Concept Modelling – Deep dive understanding of topics.
- Standards Development – Development of standards content.
- Internal Review – Targeted review.
- Public Review – User community review.
- Publication – Freely available on the CDISC website.
Topics in the User Guide cover the following areas:
- Information about the participant (e.g., demographics, vital signs, medical conditions, treatment, healthcare utilization, reproductive development, diet and nutrition, substance use, laboratory assessments, and body system assessments)
- Information about the participants family (e.g., background, medical conditions, procedures, medications, and substance use)
- Pregnancy and birth (e.g., pregnancy and birth events, multiple births)
- Study conduct (e.g., study identifier elements and arms, protocol milestones and subject disposition, visits, eligibility criteria and product accountability)
- Links to questionnaires, ratings and scales supplements of interest to Paediatric research
The Paediatrics User Guide team are currently in the process of resolving the public review comments. Once all comments have been addressed the User Guide will be freely available on the CDISC website for use globally.