WebThe sponsor workspace is a single online portal for clinical trial sponsors and other organisations involved in running clinical trials to apply to carry out a trial in the EU … WebCTIS workload functionalities for the sponsor workspace This section outlines the steps that sponsor users should follow to use the Notices & alerts tab. CTIS supports sponsor users …
Website outages and system releases - EMA
WebTransition period. The Clinical Trials Regulation foresees a 3-year transition period to CTIS. From 31 January 2024 until 30 January 2024 at 16:15, clinical trial sponsors can choose to submit their clinical trial applications under the Clinical Trials Directive (EC) No. 2001/20/EC through national submission processes, or under the Clinical ... WebEUSurvey is an online survey-management system built for the creation and publishing of globally accessible forms, such as user satisfaction surveys and public consultations. toxoplasmose foetale
Clinical Trials Information System (CTIS) List of known issues for ...
WebThe European Medicines Agency (EMA) has published a new handbook helping sponsors prepare themselves for using CTIS, which is aimed at pharmaceutical companies, contract research organisations (CROs), small and medium-sized enterprises (SMEs), academic sponsors and any other organisations involved with clinical trials. WebThe CTIS is the business tool for the Regulation and will become the single-entry point for clinical trial submission, authorization, and supervision in the EU. The CTIS will allow Sponsors to submit a single application to conduct trials in all European countries rather than apply separately in each country. WebPrinciples for Sponsor organisation modelling for CTIS Introduction Introduction This document is aimed at individuals that will be involved in implementing CTIS in clinical trial … toxoplasmose folder