Managing Clinical Trials in Europe: The Clinical Trial Information System (CTIS)

This presentation provides a detailed overview of the Clinical Trial Regulation (CTR, EU No. 536/2014) and the Clinical Trial Information System (CTIS), which became fully applicable in 2022. It explains how CTIS streamlines and harmonizes the clinical trial application and supervision process across EU/EEA countries, replacing the fragmented system under the earlier Clinical Trials Directive (2001/20/EC).

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Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2025-09-29
DOI
https://doi.org/10.5281/zenodo.17223579
Primary Topic
Economic, Social, and Health Studies
Type
article
Field-Weighted Citation Impact
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article

Managing Clinical Trials in Europe: The Clinical Trial Information System (CTIS)

Zenodo (CERN European Organization for Nuclear Research)
Economic, Social, and Health Studies
article

Managing Clinical Trials in Europe: The Clinical Trial Information System (CTIS)

article en

Abstract

This presentation provides a detailed overview of the Clinical Trial Regulation (CTR, EU No. 536/2014) and the Clinical Trial Information System (CTIS), which became fully applicable in 2022. It explains how CTIS streamlines and harmonizes the clinical trial application and supervision process across EU/EEA countries, replacing the fragmented system under the earlier Clinical Trials Directive (2001/20/EC).

Zenodo (CERN European Organization for Nuclear Research)
Medical Products Agency (SE), Direktoratet for medisinske produkter (NO)
Partnerships for the goals
Openalex Percentile: Top 34%
Economic, Social, and Health Studies
DOIOpen Access PDFOpenAlex
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Managing Clinical Trials in Europe: The Clinical Trial Information System (CTIS) · Zenodo (CERN European Organization for Nuclear Research) (2025) | TGRS Research Map | TGRS