Say the Right Thing: Developing a Program Lexicon for Cross-Functional Teams

Abstract

Achieving consistency in terminology and speaking with one voice in clinical documents is challenging for several reasons. Cross-functional team members, including medical writers, may use different terminology to describe the disease, condition, and study features, as well as to compare and interpret clinical data. Inconsistent use of terminology in clinical documents can negatively impact the overall quality, efficiency of development, and clarity of messaging and may lead to longer regulatory reviews, extensive questions from regulators, delays in approval, and the possible rejection of a regulatory submission.

The development and use of a program lexicon can alleviate some of these challenges. The lexicon is created by the lead medical writer with input from all involved functional areas. The purpose of the lexicon is to provide detailed program-specific guidance for appropriate terminology to create accurate and consistent content within and across documents for use by all contributing authors and reviewers from document initiation to finalization. For regulatory medical writers, a lexicon is an integral part of the focused authoring approach in using consistent comparison language. The lexicon identifies the terminology that should be used, should not be used, if any exceptions are allowed, and examples.

Medical writers often drive the development, implementation, and periodic updates of the lexicon to maintain it as a living document. Once developed and used, the lexicon can facilitate faster authoring, review, and quality control of regulatory documents, and meeting tight timelines for regulatory responses or submissions. By standardizing terms and definitions, the lexicon also facilitates automation, structured authoring, and content reuse. Finally, the lexicon can be included as a source file for artificial intelligence tools to produce first drafts of documents that meet regulatory requirements.