Data Standards User Guide for Pediatrics (Paediatrics User Guide)

John Owen, Beate Aurich, H. Bae, Giacomo Cavallaro, Ronald Cornet, Eva Degraeuwe, Corinna Engel, U. Felderhoff, A. Franz, P. Gandini, Victoria Hedley, A Hung, Dipak Kalra, B. Karadag, Rebecca Leary, T. Luethy, Salma Malik, Richard Marshall, Y. Medisetti, Sinéad NallyAvril Palmeri, M. Peddineni, Laura Persijn, S. Rasegaonkar, D. Schaufelberger, K. Scott, Anando Sen, C. Soklilik, A. Sridharan, A. Stauch, Jacques Thuet, Mark A. Turner, S. Urru, S. Vanderschaeghe , Melissa Walsh, Simon Woodworth, J. Yoon

Research output: Other contribution

Abstract

Clinical Data Interchange Standards Consortium (CDISC) and conect4children (c4c) have announced the release of a Paediatrics User Guide, freely available on the CDISC website (free CDISC registration required), to facilitate the development of medicines for children. The User Guide focuses on cross-cutting clinical concepts related to paediatric research and describes how to use CDISC standards to collect and structure data used in clinical trials to facilitate the aggregation of information, take advantage of big data and support data sharing. Adopting CDISC standards is an invaluable investment that leads to more meaningful, more efficient research by streamlining the flow of data throughout the research process.
Original languageEnglish
PublisherClinical Data Interchange Standards Consortium (CDISC)
Place of PublicationAustin, Texas
Publication statusPublished - 22 Feb 2023
Externally publishedYes

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