Free CDISC Paediatrics User Guide On-Demand Training

Free CDISC Pediatrics User Guide v1.0 On-Demand Training 

The JWMDRC connect4children (c4c) team are proud to have partnered with CDISC (Clinical Data Interchange Standards Consortium) to produce free, on-demand training to equip participants with essential skills for implementing CDISC standards in pediatric research. The course offers both a foundational overview and practical guidance to support efficient, standards-based study design. 

CDISC standards are required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), recommended by the China National Medical Products Administration (NMPA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. 

Course Description: 

The paediatric training builds on the CDISC Pediatrics User Guide v1.0, also developed in collaboration with c4c, to provide a basic overview of CDISC Foundational Standards, including the data collection standard CDASH (Clinical Data Acquisition Standards Harmonization) and the data tabulation standard SDTM (Study Data Tabulation Model). The training also provides a primer on the Pediatrics User Guide and pediatric-specific implementation examples.  

Chapter 1: Introduction to CDISC 

Chapter 2: Introduction to CDASH 

Chapter 3: Introduction to SDTM 

Chapter 4: CDISC Pediatrics Use Guide v1.0 primer 

Chapter 5: Example: Data relating to age 

Chapter 6: Example: Nutrition 

Chapter 7: Example: Auricular assessments 

Chapter 8: Example: consent and assent 

Chapter 9: Questionnaires, Ratings and Scales 

Chapter 10: Example: Associated persons 

A key objective of the training is to broaden the adoption of CDISC Standards, fostering data quality and facilitating data sharing among the global pediatric research community. 

Course-Level Learning Outcomes: 

 At the end of the module, learners will be able to: 

• Recognize CDISC standards concepts and how they relate to pediatrics studies 

• Navigate and use the CDASH and SDTM models and their corresponding implementation guides (e.g., design CDISC-compliant CRFs for a study, using extensible and non-extensible codelists, working across all CDISC domains) 

• Interpret the examples in the CDISC Pediatrics User Guide v1.0 

How to Enroll: 

Step #1: Create a cdiscID account and sign in at CDISC.org  (Click ‘Sign in’ link at top right of the homepage) 

Step #2: Access the CDISC Learning System 

Step #3: Click the direct training link: Pediatrics User Guide v1.0 Training 

 For more information, please contact avril.palmeri@newcastle.ac.uk  

 Join the CDISC Pediatric User Network to learn more about CDISC pediatric standards and to share implementation experiences.