In early 2009, the National Institute of Child Health and Human Development (NICHD) initiated an ongoing effort to establish a core library of harmonized pediatric terms, beginning with a focus on neonatal and infant examination concepts as part of a broader terminology framework. Continued efforts to harmonize pediatric terminology will support the acquisition, exchange, submission and archival of clinical research data, ultimately supporting the health and wellbeing of children.
The first four sets of terminology were the Pediatric Immunization Terminology, the Newborn Screening Terminology, Neurological Development Terminology and Pregnancy and Childbirth Terminology Subsets. In 2011 work began to establish a set of terminology for the Neonatal Research Network Terminology (NRNT) Subset. The NRNT subset contains concepts associated with neonatal research contributed by four neonatal research networks: Vermont-Oxford Network (VON), Children’s Hospital Neonatal Database (CHND), the Neonatal Research Network (NRN) and NICHD. In 2013, two of six additional project areas were begun. In 2014, Pediatric Adverse Events Terminology and Perinatal Terminology were completed; the Pregnancy and Childbirth Terminology subset was subsumed by the Perinatal Terminology subset. Pediatric Rheumatology Terminology was added in May of 2015; currently under development are Pediatric Nephrology Terminology, Pediatric Endocrinology Terminology, Pediatric Infectious Disease Terminology and Pediatric Hematology-Oncology Terminology. In addition, in 2015, the Pediatric Terminology adopted three subsets of terminology from the Clinical Data Interchange Standards Consortium (CDISC); this was done to leverage work already done by the CDISC group and mandated for use in clinical trial submissions by the Food and Drug Administration (FDA). Those subsets are the Anatomical Location Terminology, Directionality Terminology and Laterality Terminology subsets. An explanation for the CDISC (Standard Data Tabulation Model (SDTM) is located in the …
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