Launched on May 19, 2015, the International Neonatal Consortium (INC), a Critical Path Institute (C-Path) consortium formed to forge a predictable regulatory path for evaluating the safety and effectiveness of therapies for neonates. Operating in the pre-competitive space, INC addresses the need for measurement and assessment of clinical outcomes in neonates through teams that share data and expertise to advance regulatory science. This work will enhance regulatory science for neonates by providing standardized terminology for adverse event reporting maintained and published as part of the NCI Thesaurus (NCIt). The National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS) and INC have collaborated in this effort and EVS will house and maintain terminology to support the efforts of INC.
The Clinical Pharmacology workgroup of INC developed a neonatal adverse event severity scale to help researchers use a common approach when reporting adverse events (AEs). A collaboration with the Medical Dictionary for Regulatory Activities (MedDRA) has enhanced the INC AE Terminology by providing a mapping of the INC AEs to MedDRA LLTs. Graded AEs are mapped "narrower than" to the higher level concept.
INC files are available for download from the NCI EVS ftp site (https://evs.nci.nih.gov/ftp1/Pediatric_Terminologies/INC/) in two formats, an excel spreadsheet and a text file. A representation of the hierarchy of the INC AE terms is provided as well; the terms in this hierarchy, which are restricted to INC AE terms only, do not necessarily have a direct parent-child relationship within the NCI Thesaurus (NCIt). This file is provided to aid in the visualization of the terms specific to the INC AE Terminology project. A Changes.txt file is published monthly and contains all changes that have been made to INC Terminology files in the current production version of the NCIt when compared to the most recently posted previous file. A letter precedes the data that has changed from the previous version; "A" precedes a New Term for that subset, "C" precedes any modification to a concept, "D" precedes a term that has been deleted.
Files available for download:
- NCIt-INC Demographic and Maternal Terminology:
- NCIt-INC Demographic and Maternal Terminology NCIt-INC Demographic and Maternal Terminology in spreadsheet format.
- NCIt-INC Demographic and Maternal Terminology NCIt-INC Demographic and Maternal Terminology in tab-delimited text.
- NCIt-INC Demographic and Maternal Terminology Changes Changes between the current and most recent version of the NCIt-INC Demographic and Maternal Terminology in a tab-delimited text file.
- NCIt-INC Demographic and Maternal Terminology Version The current version of the NCI Thesaurus which contains the posted terminology.
- NCIt-INC Adverse Events Terminology:
- Japanese Translation of INC NAESS The adverse events terminology mapped to MedDRA in spreadsheet format and translated into Japanese. INC is responsible for the translation.
- NCIt-INC-MedDRA Adverse Events Terminology The adverse events terminology mapped to MedDRA in spreadsheet format.
- NCIt-INC-MedDRA Adverse Events Terminology The adverse events terminology mapped to MedDRA in tab-delimited text.
- NCIt-INC-MedDRA Adverse Events Terminology Changes Changes between the current and most recent version of the INC AE terminology in a tab-delimited text file.
- NCIt-INC-MedDRA Adverse Events Terminology Version The current version of the NCI Thesaurus which contains the posted terminology.
- NCIt-INC Adverse Events Terminology Hierarchy A hierarchical representation of the adverse events terminology to facilitate viewing the terminology.
Spreadsheet column headers:
* These columns are only contained in the mapping files.
Spreadsheet Column Content Description Column A:
NCIt Code of Subset
The unique identifier assigned to the INC subset concept. Column B:
Subset Preferred Term
The Preferred Term chosen as the name of the Subset Association. Concepts belonging to a particular list of terms are linked by a subset association. Column C:
A unique, machine readable string that begins with a "C" and is followed by a series of digits; each concept in the NCIt has one concept code. Column D:
NCIt Preferred Term
The Preferred Term, the most commonly used term for a particular concept. Each concept has one NCIt PT. Column E:
The meaning of a concept as defined by NCIt. Column F:
INC Preferred Term
The Preferred Term chosen by the INC working group members. Column G:
The Synonym chosen by the INC working group members. A Synonym is considered to possess the same meaning as the Preferred Term within a particular concept. Column H:
The meaning of the concept as defined by the INC working group members. Column I*:
The MedDRA term to which the concept is mapped. Column J*:
The code assigned to the MedDRA Term by MedDRA. Column K*:
Relationship to MedDRA Term
The relationship between the NCI Thesaurus concept and the MedDRA Term; this reads as the NCIt term is related to the MedDRA term as being either: Has Synonym, Broader Than, Narrower Than or Related To the MedDRA term. Column L*:
MedDRA Term Type
The MedDRA Term Type. Column M*:
MedDRA Terminology Version
The MedDRA version used in this mapping.
The database is reconciled the last Monday of every month; this is the database from which a production version is generated to correspond to the files posted on the ftp site. The files will be posted during the following two weeks. Additional terms may be suggested at the Term Suggestion page; please indicate INC as the project.
Previous versions of the NCIt-INC Terminology files can be found on the following website (https://evs.nci.nih.gov/ftp1/Pediatric_Terminologies/INC/Archive)
Help requests on these files should go to NCIThesaurus@mail.nih.gov