Consistency in Adverse Event Terminology: Merck's Modified Clinterm

Abstract

A coordinated dictionary system has been developed by Merck Research Laboratories to improve the consistency of terminology used to code both pre- and postmarketing adverse event reports. This dictionary, referred to as CLINTERM, was compiled by harmonizing separate vocabularies previously used for clinical trials and regulatory reporting. The redesigned dictionary, which is used for clinical research and regulatory applications worldwide, features preferred term classifications, an extensive vocabulary of “actual” terms, and customized query categories. It will also incorporate WHO ART and COSTÅT translations. Coding and data entry are simplified by entry of the verbatim reported term with automatic mapping to the encoded preferred term. To maintain the integrity of the dictionary, and assure timely and appropriate maintenance, proposed additions and changes are evaluated cooperatively by medical representatives of each user group.