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Submission of an initial Clinical Trial Application in CTIS – structure, data and documents of an initial application dossier. SME and academia Clinical Trials Information System (CTIS) two-part training webinar. Presented by Laura Pioppo on 04 March 2021. European Medicines Agency, 2021.
Early clinical trials are the first contact of regulators with innovation. CTCG will monitor these trends and evolutions in clinical trials and will develop and publish guidance documents. CTCG Mandate | pdf.
The Common Technical Document (CTD) was designed to provide a common format between Europe, USA, and Japan for the technical documen-tation included in an application for the registration of a human pharmaceutical product. The CTD dossier is divided into five main modules: Module.
The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU/EEA, via CTIS. CTIS contains the centralised EU portal and database for clinical trials foreseen by the Regulation.
Structure research dossier in CTIS. The application dossier consist of a Part I and a Part II. The list of required documentation and information is set out in Annex I of the CTR. The documents in the clinical trial application should be in a searchable format.
The investigational medicinal product dossier ( IMPD) should be provided in a clearly structured format following the CTD format of Module 3 and include the most up-to-date available information relevant to the clinical trial at time of submission of the clinical trial application.
This document aims at providing specific guidance on the content of a dossier for clinical investigations under MDR from a national point of view. Version 2.0, 07.06.2021
