WebEMA plans regular maintenance windows for CTIS, during which users are advised to avoid using CTIS or the website: Monday to Friday, from 18:00 – 21:00 Amsterdam time. Each first Saturday of the month, from 10:00 - 14:00 Amsterdam time. The time zone used in CTIS is Central European Time (CET). All due dates and deadlines are displayed in CET ... WebMar 1, 2024 · The Clinical Trials Information System (“CTIS”) is the centralised EU online portal and database for regulatory submissions, authorisations and supervision of clinical trials across the EU/EEA.
CTIS publication rules: how CTIS supports access to clinical …
WebMay 20, 2024 · The European Medicines Agency (EMA) has announced that its long-delayed clinical trial EU Portal and Database, one of the main features of the Clinical Trial Regulation 536/2014 and the key component of the Clinical Trial Information System (CTIS), is now finally fully functional and fit for purpose with 31 January 2024 pencilled in as the … WebArticle 21-22 –SM to aspects covered by Part I+II •Procedure follows timelines for part I assessment previously discussed. •When a SM covering both part I and part II aspects is … gym prices milan
High level overview, JCA and publication rules of CTIS
WebSep 12, 2024 · This workshop provides an opportunity for invited stakeholders to present their views on the draft guidance on protection of personal data and CCI for documents uploaded and published in the Clinical Trial Information System (CTIS), which is under open consultation until 8 September 2024. WebEudraCT to CTIS during the transition period defined in Article 98 of the CTR. This is to indicate in CTIS that this concerns a clinical trial authorised in the context of Directive 2001/20/EC and to indicate that the trial is transitioning. 4. The CTIS Data Protection area focuses on key activities and timelines in relation to the technical WebArticle 81(4) outlines the requirements for transparency in CTIS: 4. The EU database shall be publicly accessible unless, for all or part of the data and information contained therein, confidentiality is justified on any of the following grounds: (a) protecting personal data in accordance with Regulation (EC) No 45/2001; bp ballito