Clinical Trials Information System Reaches Major Milestone Towards Go-Live
As per the latest update posted on 21 April 2021, EMA’s Management confirmed that the clinical trial EU Portal and Database, one of the main deliverables of the Clinical Trial Regulation and the key component of the Clinical Trial Information System (CTIS), is now fully functional and on track to go live by 31 January 2022.
The Board confirmed that it has verified that the system meets the agreed requirements during an extraordinary meeting held on 21 April following an independent audit of the new IT system.
The below update was posted on EudraCT What’s New section, on April 16, 2021:
A new version of the Frequently Asked Questions is now available for users and more detailed instructions are now provided in the tutorials on posting results.
- Q. 30: Provides more information regarding a third country trial
- Q. 55: Provides an additional reference for contents of results information to be included in a summary attachment
- Q. 67: Question updated to add ‘user or delegated preparer’
- Q. 70: Provides information for a sponsor to directly upload a PDF document; previously, the NCA was to be contacted who would then upload the document
- Q. 78: Statement added ‘A link to the old version will remain published in the EU CTR to keep track of the changes and for transparency reason.’
- Q. 81: Addition of statement about errors and warning
- Minor grammatical and typographical corrections
TranspariMed published an article How will national regulators in Europe impose fines for missing clinical trial results?
In this article, TranspariMED’s legal analyst Muhammad Dwistaraifa Rasendriya explains the legal context and how the process will work. As a summary, even though national medicines regulators will get clear legal powers to impose fines and other sanctions on European companies and institutions that fail to make the results of their drug trials public, there will be variation in the amount/type/applicability of the penalty depending on what act/law is passed in each EU country.
Click here for the original article.
The EMA Management Board meeting took place on March 11, 2021, and the highlights for the same were published on March 12, 2020.
As noted in the report, the Board agreed to revise the go-live date to 31 January 2022. This go-live date is the aspiration of the Board, being without prejudice to verification of the final audit outcome and full functionality of CTIS by the Management Board, and the subsequent decision process of the European Commission. The final go-live will take place exactly six months after the publication of the Commission decision in the Official Journal of the European Union.
Day 2 of the SME and academia Clinical Trials Information System (CTIS) two-part training webinar arranged by EMA took place on March 04, 2021. EMA has made available the presentations from Day 2 of this CTIS training webinar on March 03, 2021.
Clinical Trials Information System (CTIS) Training: Day 1 Webinar Presentations
SME and academia Clinical Trials Information System (CTIS) two-part training webinar was announced on 19/01/2020. Day 1 of the webinar was held on 22 February 2021. Presentations were provided by EMA system experts, European Commission, and presenters from SME and academic institutions during the webinar. The presentations from the Day 1 of the CTIS training webinar were made available by EMA on 26 February 2021.
EMA published a document Clinical Trials Information System (CTIS) Training – Information update on progress, on February 01, 2021.
The document provides a summary of training webinars planned by EMA for using CTIS, throughout the year. The details of the master training for sponsors and training for SMEs (micro, small and medium-sized enterprises) and academia and other non-commercial clinical trial sponsors are already published.
There will be two additional events:
- A third training for the end-users from all sponsor groups to provide training in their role-specific functionalities (e.g. administrator, preparer, submitter). This stream will be initiated closer to CTIS Go-live in Q4 of 2021.
- A survey to collect information from commercial industry sponsors, SMEs and non-commercial sponsors interested in the CTIS training programme. The survey is open for completion until 8 February 2021 at 12 CET to obtain input on clinical trials sponsors (end-user organisations) interest for CTIS sponsor training events. EMA has provided the link to the survey: Link.
SME and academia Clinical Trials Information System (CTIS) two-part training webinar were announced on 19/01/2020. This two days training webinar would provide essential information on CTIS for micro, small and medium-sized enterprises (SMEs) and non-commercial (academic) sponsors.
Day 1 of the webinar would be held on 22 February 2021. It will cover:
- Overview of CTIS
- User access management, including how to register users
- Sponsor user management
- Sponsor roles and permissions in CTIS
Day 2 of the webinar would be held on 4 March 2021. It will cover:
- Submitting an initial trial application in CTIS
- Updating an initial trial application, including making substantial modifications and adding a Member State concerned
- Making non-substantial modifications
- Submitting trial results
Registration must be done by completing the expression of interest questions by 29 January 2021. Registrations will close on 7 February 2021. Registration for each day of the webinar must be done separately. The webinar is limited to 950 participants only. EMA will publish the video recording of the webinar.