July 2021: CTIS Updates

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 Thus, the system will accommodate for two versions of the trial documents, one ”for publication” (redacted) and one ”not for publication” (not redacted).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.

CTIS: Training Update

European Medicines Agency updated the page Clinical Trials Information System: training program, on July 26, 2021, by adding the below documents in CTIS Training Module 18 (How to submit an annual safety report and respond to related RFIs):

  1. Step-by-step guide: How to submit an annual safety report and respond to related RFIs (PDF): It provides step-by-step guidance on how to create and submit annual safety report (ARF). It also provides guidance on how to respond to RFIs during the assessment of an ASR with insights and screenshots.
  2. Instructor’s Guide: How to submit an annual safety report and respond to related RFIs (PDF): It contains an overview on how to create and submit the  ARF form in CTIS and guidance for trainers for disseminating the training materials.
  3. FAQs: How to submit an annual safety report and respond to related RFIs (PDF): It contains questions regarding the sections, creation, submission, assessment, the roles and permissions of ARF form and questions for RFIs related to ARF with diagrams for better understanding.
  4. Process Puzzle: How to submit an annual safety report and respond to related RFIs (PPT): It includes exercises useful for understanding steps for submission of ARF with different case scenarios and its solutions in pictographic form.

July 2021: CTIS Webinar Update

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.

 

July 2021: EMA Management Board Meeting on CTIS Audit

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.

July 2021: CTIS Webinar Update

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.

 

July 2021: CTIS Training Update

European Medicines Agency updated the page Clinical Trials Information System: training programme, on July 09, 2021, by adding new versions of the below documents in CTIS Training Module 17 (Supervise a clinical trial – Ad hoc assessment):

  1. Instructor’s Guide: Supervise a CT – Ad Hoc Assessment: It contains an overview of how to complete the ad hoc assessment form in CTIS including guidance steps, activities, exercises with solutions for trainers and screenshots for better understanding.
  2. Step-by-step guide: Supervise a CT – Ad Hoc Assessment: It provides step-by-step guidance on how to create, search and view an ad hoc assessment, with screenshots.
  3. FAQs: Supervise a CT – Ad Hoc Assessment: It contains questions regarding the creation, requests for information and consultation, the update and completion, the roles and permissions, the search, view, and download of an ad hoc assessment.

July 2021: CTIS Webinar Update

European Medicines Agency uploaded a PDF  Speakers – Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS over the What’s New Section on July 08, 2021.

The document consists of bios of all the speakers that will be articulating in the upcoming CTIS webinar-Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS that will be held on July 29, 2021.

Additionally, the agenda for the event was uploaded on July 06, 2021, on the event page.

July 2021: CTIS Training Update

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):

  1. 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.
  2. 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.
  3. 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.
  4. 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.

July 2021: CTIS Update

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) and Module 16 (Supervise a Clinical Trial and a Clinical Trial: Inspection records):

  1. Instructor’s Guide: How to search, view and download a CT and a CTA (Authority)-Module 15
  2. FAQs: How to search, view and download a CT and a CTA (Authority)– Module 15
  3. Quick guide:How to search, view and download a CT and a CTA (Authority)– Module 15
  4. Step-by-step guide: How to search, view and download a CT and a CTA (Authority)– Module 15
  5. Process puzzle exercise : Supervise a Clinical Trial and a Clinical Trial: Inspection records– Module 16
  6. Step-by-step guide: Supervise a Clinical Trial and a Clinical Trial: Inspection records– Module 16
  7. FAQs: Supervise a Clinical Trial and a Clinical Trial: Inspection records– Module 16
  8. Instructor’s guide: Supervise a Clinical Trial and a Clinical Trial: Inspection records– Module 16

These are guidance documents for authority users and contains an overview of the training materials available with explicit explanation provided for each section, 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.

June 2021: CTIS Training Update

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):