Work

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

Year: 2025

Type: article

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).

Source: Zenodo (CERN European Organization for Nuclear Research)

DOI: 10.5281/zenodo.17223579

Author: Beate, Rindal

Institution: Direktoratet for medisinske produkter

Language: English

Topic: Biomedical Ethics and Regulation

Subfield: Physiology

Field: Medicine

Domain: Health Sciences

Open Access status: green

Funder: European and Developing Countries Clinical Trials Partnership

OpenAlex ID: W7083698627

FWCI:

Cites:

Cited by:

Related to: