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Adverse Events Terminology Standards, Data Elements and Case Report Forms

By Sherri de Coronado1, Ann Christine Catlin, Sumudinie fernando, Denise Warzel2

1. NCI Center for Biomedical Informatics and Information Technology 2. National Cancer Institute

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Abstract

Standards for coding, naming and grading adverse events (AEs) in cancer clinical trials include both cancer-focused and broader systems that all result from collaboration among academic, governmental, and pharmaceutical industry clinical investigators. They are all based on the need for reproducible, consistent and readily usable adverse event data and analysis.

This resource page for Adverse Events Data Standards is the work of the NCI Semantic Infrastructure Team.


Four Adverse Events Terminologies

There are four specialized adverse events terminologies that are used in coding cancer clinical trial adverse events, two cancer-focused and two broader:

MedDRA Medical Dictionary for Regulatory Activities or MedDRA is the widely accepted international standard, and other standards are generally harmonized with it. Its web home is here, and the terminology can be found and searched using the NCI Term Browser.
CTCAE Common Terminology Criteria for Adverse Events or CTCAE is the widely accepted standard for cancer treatment trials, harmonized with MedDRA at the AE level and adding severity grading that is not part of MedDRA. The CTCAE terminology web home is here, and it can be found and searched using the NCI Term Browser.
PRO-CTCAE Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events or PRO-CTCAE is being developed as a MedDRA-compliant system for cancer patient self-reporting of symptom adverse events. PRO-CTCAE's web home is here.
CDISC Clinical Data Interchange Standards Consortium or CDISC international standards for clinical research reflect MedDRA and CTCAE in their available codelists. A web overview of CDISC terminology standards, several of which include specifications for adverse event coding, is here.


Discover and Discuss

Adverse Events Data Elements, Case Report Forms and Vocabulary at the Standards Portal can be explored using DataViews and discussed at the Group Site:

Common Data Elements DataView Case Report Forms DataView Vocabulary DataView Discussion Group Site

Cite this work

Researchers should cite this work as follows:

  • Sherri de Coronado; Ann Christine Catlin; Sumudinie fernando; Denise Warzel (2014), "Adverse Events Terminology Standards, Data Elements and Case Report Forms," https://nciphub.org/resources/112.

    BibTex | EndNote

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