Now it could take days to have a substance added in section D. The process is described in the Frequently Asked Questions. The statistics for October are now available. We would like to make Sponsors aware there is an issue with the assignment of primary users of trials, as well as with the activation of results user roles in EudraCT. Our IT is working to fix it as soon as possible.
We thank you very much for your patience and we apologise for the inconvenience. The release notes for EudraCT version number The statistics for September are now available. Sponsors of trials that are "prematurely ended" can now post results in EudraCT as a pdf document. Please refer to the Tutorials on posting results in order to know how to become a primary user for your trial and post the pdf document.
After the document has been uploaded, kindly click on "post results" on the top right corner. The document will be published in EU CTR after 2 weeks from posting date except for phase 1 trials in adults, that are not publicly available, see FAQs.
A new version of the document " Results: modalities and timing of posting " is now available. This document provides more clarity regarding the modality of results posting for trials ended before 21 July and between 21 July and 21 July Computer application maintenance weekend September Essential maintenance work will be carried out to all EMA Telematics applications. As a result, the EudraCT website will be unavailable to users between hrs on Friday, 18th September and hrs on Monday, 21th September As a result, EudraCT systems will be intermittently unavailable between hrs and hrs of Saturday, 11 July The frequently asked questions have been updated.
Previous news can be found here. For the UK, as from 1. Contact us. For further details, see the highlights published after the meetings of the Management Board. EMA and the Member States are fully committed to ensuring the success of this project and its delivery. Progress updates are available below on the development of CTIS and its functionalities, rollout of training and user support. To subscribe to the newsletter, write to ct.
The Clinical Trials Regulation requires all information stored in the database to be publicly available , unless exempted under the Regulation to protect:. EMA has added two sets of requirements to the functional specifications for applying the exceptions :. In preparation for the implementation of the Regulation, the European Commission published on 1 June the following guidance documents for public consultation until 31 August For more information, see European Commission: Clinical trials - Major developments.
The Agency consults on its proposals with EU Member States, the European Commission and stakeholders representing non-commercial and commercial clinical-trial sponsors, healthcare professionals and patient groups.
EMA consulted on the draft functional specifications in October A total of 47 individuals and organisations submitted more than comments:. EMA held a three-month consultation in on implementing the transparency rules. Over 80 different individuals and organisations submitted more than 1, comments:.
Please do not include any personal data , such as your name or contact details. Skip to main content. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. Human regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products. Clinical Trials Regulation.
Aims and key benefits of the Regulation. The Regulation will require: consistent rules for conducting clinical trials throughout the EU; information on the authorisation, conduct and results of each clinical trial carried out in the EU to be publicly available. The key benefits of the Regulation include: harmonised electronic submission and assessment process for clinical trials conducted in multiple Member States; improved collaboration, information-sharing and decision-making between and within Member States; increased transparency of information on clinical trials ; highest standards of safety for all participants in EU clinical trials.
How the Clinical Trials Information System will work. EMA published the functional specifications for the EU portal and database available through CTIS to be audited in December , following a public consultation: Functional specifications for the EU portal and EU database to be audited The system will support the day-to-day business processes of Member States and sponsors throughout the life-cycle of a clinical trial in a user-friendly way.
Sponsor workspace A secure workspace will assist clinical trial sponsors in preparing and compiling data to submit to the system for assessment by Member States.
It will allow sponsors to: manage users and user roles within their organisations; compile clinical trial application dossiers for new and updated trials; cross-reference to product documents in other clinical trials ; upload documents for clinical trial application submission; receive alerts and notifications for ongoing trials; respond to requests for information and view deadlines; search and access clinical trials ; record clinical trial results.
Authority workspace A secure workspace will support the activities of Member States and the European Commission in overseeing clinical trials. It will allow Member States to: manage users and user roles within their organisations; view clinical trial application dossiers; manage tasks related to the assessment of clinical trials ; collaborate within and between Member States; receive alerts and notifications for ongoing trials; download documents submitted by clinical trial sponsors; record inspections of sites and clinical trials.
Public website Through the website, members of the public can access detailed information on all clinical trials conducted in the EU, in all official EU languages. The website will provide the following features: overview of clinical trial statistics; advanced search; download data and reports; site updates and announcements. Clinical Trials Information System development.
CTIS is due to go live on 31 January EMA is working towards go-live, with the plan below. List item. For more information on the original delivery timeframe, see: Original delivery time frame for the EU portal and EU database.
Progress updates. Editions start from June Transparency rules. The Clinical Trials Regulation requires all information stored in the database to be publicly available , unless exempted under the Regulation to protect: personal data; commercially confidential information , in particular the marketing-authorisation status of the medicine, unless there is an overriding public interest; confidential communication between Member States in the preparation of their assessment; supervision of clinical trials by Member States.
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