European Medicines Agency published a few documents related to the Clinical Trial Information System, on July 29, 2021.
The Clinical Trial Information System (CTIS) – Sponsor Handbook provides detailed information regarding the use of the new system including user management, documents submissions throughout the life-cycle of a clinical trial and directions for users during the 3-year transition period. Section 9 explains data transparency. The data and documents submitted to the CTIS for the trial will be made available to the public. Personal and commercial confidential information are exempted from publication. Thus, the system will accommodate for two versions of the trial documents, one ”for publication” (redacted) and one ”not for publication” (not redacted). Provisions for deferrals will be applicable for redacted documents.
Additionally, the below templates were also made available on the same day. All these templates provide an overview of the system covering screenshots of the different sections associated with each type of application:
CTIS Structured data form Instructions – initial application, additional MSC, substantial and non-substantial modifications: Provides guidance on the data fields sponsors will fill in CTIS when creating an initial application (IN), an additional member state concerned application (AMSC), a substantial modification (SM) and a non-substantial modification (non-SM). It also covers the document types involved in each form and the availability of publication and deferrals for these.
CTIS Structured data form Instructions – multi-trial substantial modification: Provides guidance on the data fields sponsors will fill in CTIS when creating a multi-trial substantial modification. This application differs from the above-mentioned ones in the way that i) it has all fields that are editable in the Form section ii) there is no MSCs section and iii) Part I and II are not editable; are pre-populated. It also covers document type, publication and deferral related details.
CTIS Structured data form – Notifications: Provides guidance on the data fields sponsors will fill in the ‘Notifications’ sections in CTIS. The different notifications include start, end and restart of both trial and recruitment, temporary halt, global end of trial, unexpected event, serious breach, urgent safety measure, inspection and updating results date.
European Medicines Agency updated the Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS event page on July 14, 2021, by adding a EU survey portal for participants interested in the webinar to submit questions in relation to sponsor preparedness in advance of the event, by July 20, 2021. Participants can submit up to 5 questions regarding a pre-specified agenda topic. It was also mentioned that the most popular questions submitted in advance will be answered by the speakers during the webinar.
European Medicines Agency (EMA) published a document on the minutes of the management board meeting on the Clinical Trial Information System (CTIS) audit on July 14, 2021.
The meeting was held virtually on April 21, 2021. The main aim of this meeting was to confirm if the EU clinical trials Portal and Database (EUPD) are fully functional and meet the functional specification. EUPD is one of the deliverables and a key component of the Clinical Trials Information System (CTIS).
Publication of the European Commission (EC) notice confirming full functionality of the EUPD will start as soon as the Management Board letter of endorsement is received. The Commission will draft an act that is intended to be published on 31 July 2021, so that the Clinical Trials Regulation can start to apply 6 months later. Also, a Joint Action for clinical trials will be launched by the EC in 2021. Additionally, the EC declared that they would be providing the legal support required for the national implementation of Regulation (EU) No 536/2014.
The timelines of the CTIS application were reemphasized in the meeting. The system is set to go live by 31 January 2022 and in the first year after CTIS is live, the sponsor will have a choice to select the old or new system. From 31 January 2023, all the new applications will be submitted to the new system, and the old system will be available only for ongoing studies. From 31 January 2025, all the ongoing studies will need to move on to the new system and the EU Directive will no longer apply.
The document also provides a summary of EUPD independent audit methodology and findings, project release plan for go-live and post-go-live, CTIS training and communication programs and confirmation on EUPD functionality as per the Clinical Trial Regulation.
Detailed information on the above-mentioned points can be found here.
European Medicines Agency updated the Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS event page on July 12, 2021, by adding a live broadcast section for participants interested in the webinar. This broadcast section will be functional on the day of the webinar i.e., July 29, 2021.
To assist with further queries a point of contact has also been provided.
European Medicines Agency updated the page Clinical Trials Information System: training programme, on July 06, 2021, by adding new versions of the below documents in CTIS Training Module 15 (Search, view and download a clinical trial and clinical trial application):
- Instructor’s Guide: How to search, view and download a CT and a CTA (Authority): It is a guidance document for authority users and contains an overview of the training materials available, and a suggested methodology for disseminating the materials. It also explains different case by case scenarios with possible solutions, justifications and screenshots for better understanding.
- FAQs: How to search, view and download a CT and a CTA (Authority): It includes questions related to searching, viewing, and downloading CT and/or CTA.
- Quick guide:How to search, view and download a CT and a CTA (Authority): It includes steps for searching, viewing, and downloading CT and/or CTA along with detailed screenshots and explanation for each section of CTA.
- Step-by-step guide: How to search, view and download a CT and a CTA (Authority): It includes steps in brief with screenshots for searching, viewing, and downloading CT and/or CTA along.
European Medicines Agency updated the page Clinical Trials Information System: training programme, on June 30, 2021, by adding new versions of the below documents in CTIS Training Module 07 (Management of registered users and role matrix):
European Medicines Agency updated the page Medical devices, on June 29, 2021, by adding a questionnaire with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746).
The PDF document has been uploaded to provide explicit guidance to Applicants, Marketing Authorisations Holders (MAH) and notified bodies (NB). The question and answers in this document are mainly related to regulatory framework and submissions of medical devices under the new Regulation (EU) 2017/745, and Regulation (EU) 2017/746. It covers questions in relation to medical devices that form an integral product with a medicinal product, medicinal products that include a medical device in the secondary packaging of the marketed medicinal product (co-packaged), and consultation procedure for ancillary medicinal substances that are integral part of medical devices.
This document will be updated regularly and will be marked by “New” or “Rev.” with the relevant date upon publication. As of now, the document does not contain any questions regarding transparency.
The third issue of CTIS Highlights was published on June 23, 2021.
It discusses two user management approaches (organization-centric and trial-centric) and the process of assigning roles in CTIS.
The other topics covered are CTIS system functionalities, Initial clinical trial application process in CTIS, Training Programme update and Audit updates. Additionally, it announces the availability of a CTIS Sponsor Handbook. EMA, in a collaborative approach including sponsor representatives, will prepare a sponsor handbook to provide sponsors with an overview of materials available to help them prepare for and use CTIS. A first version is expected to be published in Q3 2021.
A new document, Guide to CTIS training material catalogue, is made available on June 23, 2021, on the EMA’s Clinical Trials Information System (CTIS): training programme page. It includes an overview of available and planned training modules. It also outlines the life-cycle stages of a clinical trial, with reference to the relevant training modules in each stage.