On March 10, 2023, the latest CTIS Newsflash was made available in the What’s New section by the European Medicines Agency. All updates related to CTIS newsflash can be accessed from the Development of the Clinical Trials Information System page.
The information comprises essential data and patterns concerning CTA submissions, CTAs that received a decision, and CTAs with a decision per RMS for the week of February 28 to March 06, 2023, as compared to the previous week.
Below are the key updates from the newsflash:
- Multi-factor (MFA) authentication strategy: From June 01, 2023, users for both Sponsor and Member State workspaces will need to log in to CTIS using an MFA along with their respective username and password. Users may choose their preferred second-factor method and amend their MFA options (a token in the Microsoft app, text to a mobile phone, or call on an office phone) at any time. Users can sign into the EMA ServiceNow portal to configure their MFA for EMA systems, which, once deployed and enabled, will also work for CTIS.
- Submission of partial initial clinical trial application:
- As per the requirements of Article 11 of the Clinical Trial Regulation (CTR), sponsors can submit partial initial clinical trial applications by submitting an application with Part I to all Member States Concerned (MSC) and part II to none or some MSC.
- From the time Part I is submitted until a decision is issued by the Member State, the initial application will remain under evaluation for 2 years, after which the application will lapse.
- The submission of further applications, such as substantial modifications and/or addition of an MSC, can only occur after all MSC have received both Part I and Part II of the dossier.
- Any future changes to the partial initial application functionality in CTIS will be communicated to users in advance.
On March 03, 2023, the latest CTIS Newsflash was made available in the What’s New section by the European Medicines Agency. All updates related to CTIS newsflash can be accessed from the Development of the Clinical Trials Information System page.
The information comprises essential data and patterns concerning CTA submissions, CTAs that received a decision, and CTAs with a decision per RMS for the week of February 21 to 27, 2023, as compared to the previous week.
On March 01, 2023, a CTIS update was released, which introduced the following improvements:
- Alerts will no longer be generated when an initial clinical trial application (CTA) is withdrawn across all Member States.
- The search function has been enhanced to retrieve medicinal products with more than 35 substances and to add a product using the ATC code.
- The issues related to duplication of IMP and auxiliary medicinal products (AxMP)-related documents have been resolved.
For more information, the current version of the release notes and lists of known issues and proposed workarounds can be accessed.
On March 02, 2023, the Danish Medicines Agency published the following update in the News section of its website.
Based on the Professional Forum conducted by the Danish Medicines Agency (DMA) and the Danish Centre for Ethics on January 31st, 2023, the DMA has updated its guidelines on the application and conduct of clinical drug trials under the EU Regulation and has included a trial protocol structure template.
With this update, the Danish Medicines Agency aims to provide a condensed overview of the different guidelines and training programs issued by the European Medicines Agency (EMA) and the legislation related to the EU regulation, as well as a question/answer section to supplement the existing guidelines.
The trial protocol template outlines the necessary information to meet the EU regulation and ICH-GCP requirements for a protocol.
More information can be found here.
On February 20, 2023, EMA published the thirteenth issue of the Clinical Trials Highlights. All Clinical Trials Highlights updates are posted on the Development of the Clinical Trials Information System page.
Starting from January 31, 2023, sponsors are required to submit their initial clinical trial applications through CTIS. EMA has resolved a considerable number of issues, improving the user experience and providing system enhancements by strengthening the notices and alerts functionality, enhancing the creation and preparation of application documents and data, and enhancing the authorization and supervision of clinical trials.
The CTIS User Support Service has been strengthened to address user inquiries effectively, and the steps to raise a ticket are provided. Additionally, EMA issues a weekly CTIS Newsflash that includes significant updates on new releases and system developments, reminders about upcoming training and events, and links to helpful reference material.
The upcoming CTIS events include the sponsor end-user training programs scheduled on May 02 to 05, 2023, and June 27 to 30, 2023.
On February 24, 2023, the European Medicines Agency released the most recent CTIS Newsflash via CTIS.communications. All CTIS newsflash updates are posted on the Development of the Clinical Trials Information System page.
This includes key data and trends about CTA submissions, CTAs with a decision, and CTAs with a decision per RMS for the week of February 14 to 20, 2023, as compared to the previous week.
On February 20, 2023, a CTIS “Hotfix” was implemented to enable a group of sponsors to modify an application in response to a Request for Information (RFI), by resolving database locks that had occurred in a limited number of trials. Due to the need for additional testing, the next CTIS release will take place the following week implementing all the improvements listed in the previous CTIS newsflash post. For more information, the current version of the release notes and lists of known issues and proposed workarounds can be accessed.
In addition, EMA has initiated the process of registering CTIS as a WHO data provider. Once registered, CTIS data will be accessible on the International Clinical Trials Registry Platform (ICTRP) Search Portal of the WHO.
On February 24, 2022, the European Union (EU) posted a document titled Questions and Answers Document – Regulation (EU) 536/2014 – Version 6.4.
The comprehensive responses within the document address all inquiries related to the Clinical Trials Regulation (EU CTR) No. 536/2014. This includes a wide range of topics such as the scope of the regulation within the EU, the application procedure, substantial modifications, withdrawals, the roles of individuals involved, clinical trial submission, start and end procedures, temporary halts and early terminations, the transitional period, informed consent, and any other significant modifications.
This document version includes clinical trial transparency updates to Sections 6.5, 11.6, 11.7, 11.9, and Annex II.
- Section 6.5 now includes an explanation for why deferrals and redactions cannot be used simultaneously to protect confidential commercial information (CCI).
- Sections 11.6 and 11.7 have been updated to provide guidance on submitting additional documents for transitioning clinical trial applications. If no additional documents are available, sponsors must upload a document stating that this aspect was assessed by the National Competent Authority (NCA) and/or Research Ethics Committee (REC), and is covered by the conclusion of the assessment under the Common Technical Document (CTD).
- Section 11.9 now includes information on the authorization of substantial modification documents.
- Annex II has been updated to include new language requirements for protocol synopsis, patient-facing documents as part of the protocol, labeling, and fields of the application form specifically for clinical trials in France.
On February 23, 2023, EMA posted the following update in the What’s New section of the EudraCT homepage:
The EudraCT website has been experiencing unforeseen SPOR outages, which is preventing users from performing common functions such as uploading XML files. EudraCT IT is actively working on developing a solution to this issue. Additionally, users are currently unable to access the EudraCT results training environment. However, EudraCT will inform users of its accessibility via the EudraCT webpage.
On February 21, 2023, European Medicines Agency updated the event page Clinical Trials Information System (CTIS) Webinar – 9 months on and going forward over the What’s New Section.
The CTIS event, held on November 16, 2022, is now available for viewing on the event page through a video recording. This event focused on offering practical guidance regarding the transition of clinical trials from the Clinical Trials Directive (2001/20/EC) to the Clinical Trial Regulation (536/2014). In addition, attendees were able to learn about best practices for user management and the usage of CTIS, as well as system metrics.
Additionally, CTIS Training materials – Latest updates (v1.2) is also available on Clinical Trials Information System (CTIS): online modular training program highlighting the training modules that were updated from May 15, 2022, to September 01, 2022.
On February 17, 2023, the European Medicines Agency released the most recent CTIS Newsflash via CTIS.communications. All CTIS newsflash updates are posted on the Development of the Clinical Trials Information System page.
This encompasses the key data and trends from the week of February 07 to 13, 2023, regarding CTA submissions, CTAs with a decision, and CTAs with a decision per RMS, when compared to the previous week.
In the upcoming CTIS “Hotfix,” Member States will be able to unlock database locks that have occurred in a limited number of trials and a small group of sponsors, enabling them to respond to Request for Information (RFI). This update will also permit sponsors to modify an application via an RFI.
Moreover, the upcoming release of CTIS is scheduled for the week of February 20, 2023, and is anticipated to bring several enhancements that will enhance the user experience. These enhancements consist of displaying Notices and Alerts for Union controller roles and EMA Admin, improving search functionality, rectifying the error message that appears when trying to submit an RFI response, boosting the efficiency of the Substantial Modification detail review process, and ensuring that the data download encompasses the latest entries.
For more information, please refer to our previous post on CTIS Newsflash.
On February 17, 2023 the latest version of the Q&As on the Clinical Trials Regulation has been released in EudraLex Volume 10 by the EU Commission. The updated version, which is now referred to as Version 6.4, is now available.
One of the notable updates to the Q&As on the Clinical Trials Regulation pertains to Additional Q&A (2.15). This change mainly addresses situations where the sponsor of a clinical trial is not the product owner of the investigational medicinal product (IMPD) and, therefore, is not authorized to access the quality IMPD.
For your reference, the link can be found here: regulation5362014_qa_en.pdf (europa.eu)