The Clinical Trials Information System (CTIS) has been designated as a primary registry by the World Health Organisation (WHO) within the International Clinical Trials Registry Platform (ICTRP). Becoming a primary registry means CTIS adheres to specific criteria for content, data quality and validity, accessibility, unique identification, technical capacity, and administration. This ensures comprehensive research information is accessible to healthcare decision-makers globally.
CTIS has already been a registered data provider for WHO since May 2023. Designation as a primary registry represents a significant milestone in facilitating data sharing and promoting transparency and trust in clinical research.
WHO's primary registries meet the standards set by the International Committee of Medical Journal Editors (ICMJE), which is a prerequisite for clinical trials to be published in general medical journal articles. Relevant clinical trial data from trials published in CTIS since its launch on 31 January 2022 is being included in the ICTRP search portal.
The predecessor to CTIS, the EU Clinical Trials Register, has been a WHO primary registry since September 2011.
CTIS supports the running of clinical trials for human medicines in the European Union (EU) and the European Economic Area (EEA). The system includes a public searchable database for healthcare professionals, patients and citizens to deliver the high level of transparency foreseen by the Clinical Trials Regulation. CTIS also includes a trial map that makes it easier for patients and healthcare professionals to find recruiting clinical trials near them. The authorisation and oversight of clinical trials is the responsibility of EU/EEA Member States while EMA is responsible for maintaining CTIS. The European Commission oversees the implementation of the Regulation.