Clinical Trials Information System
From Codex of clinical research
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Clinical Trials Information System (CTIS) - is the tool for the Clinical Trials Regulation (EU) No 536/2014. It functions as single entry point for clinical trial authorization and supervision in the European Union (EU) and the European Economic Area (EEA).
Purpose
CTIS is online portal which enables interactions between clinical trial sponsors, and the regulatory authorities involved in approving the clinical trial application.
External links
- Clinical Trials website, https://euclinicaltrials.eu/
- EMA, Clinical Trials Information System, https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-information-system