A Comprehensive Workspace for All Clinical Trials: The Clinical Trial Information System (CTIS) in Europe – Opportunities for Medical Writers

This article introduces the Clinical Trial Information System (CTIS), which is the mandatory workspace for sponsors, authorities, and ethics committees to authorize and supervise all clinical trials in Europe. It describes the key features of the system, its mechanics, and the associated processes including the transparency requirements. Working with CTIS offers opportunities for regulatory medical writers in ensuring compliance, efficiency, and effective communication across the clinical trial life cycle. From crafting high-quality cover letters to writing and managing responses and producing lay language documents, medical writers are well-positioned to contribute their expertise in this collaborative and time-sensitive environment.