CTIS Gains WHO Recognition as Primary Registry for Clinical Trials

As a primary registry, CTIS now meets WHO’s stringent criteria related to content quality, data validity, accessibility, unique identification, technical infrastructure, and operational administration.

The Clinical Trials Information System (CTIS) has officially been designated as a primary registry by the World Health Organization (WHO) under its International Clinical Trials Registry Platform (ICTRP).

This recognition marks a significant step in enhancing transparency, data sharing, and accessibility of clinical research worldwide.

Meeting Global Standards for Clinical Trial Registries

As a primary registry, CTIS now meets WHO’s stringent criteria related to content quality, data validity, accessibility, unique identification, technical infrastructure, and operational administration.

This ensures that health professionals, researchers, and policymakers can access comprehensive, accurate clinical trial data from across the European Union (EU) and the European Economic Area (EEA).

CTIS has been contributing as a registered data provider to WHO since May 2023.

Achieving primary registry status now enables clinical trial data submitted to CTIS since its launch on 31 January 2022 to be included in the ICTRP’s global search portal.

This inclusion facilitates better visibility and access to clinical research for the global health community.

Primary registries like CTIS comply with the standards set by the International Committee of Medical Journal Editors (ICMJE), which are required for trial data to be eligible for publication in leading medical journals.

The development supports greater public trust and integrity in clinical research by making information more openly accessible.

About CTIS & Its Role in EU Clinical Trials

CTIS is the central platform supporting clinical trials of human medicines in the EU and EEA.

Managed by the European Medicines Agency (EMA), the system includes a public, searchable database and a trial location map to help patients and healthcare professionals find relevant recruiting studies.

Member States oversee trial authorization and monitoring, while the European Commission ensures regulatory compliance.

CTIS succeeded the EU Clinical Trials Register, which had held WHO primary registry status since 2011.

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