September 2021: EU CTIS Webinar

European Medicines Agency updated about the upcoming Clinical Trials Information System- Webinar for small and medium-sized enterprises (SMEs) and academia over the What’s New Section on September 10, 2021:

The webinar will be conducted on November 29, 2021, for the small and medium-sized enterprises (SMEs) and academic sponsors of clinical trials. The agenda of the event is uploaded on the event page along with the topics that will be covered during the webinar.

For more information, click here.

September 2021: CTIS Training Update

European Medicines Agency updated the page Clinical trials information system (CTIS): online modular training programme by adding a PDF in Module 19: Quick guide – Introduction: CTIS for SMEs and Academia on September 07, 2021.

The document consists of a brief introduction to CTIS and its timeline. It also explains in detail about clinical trial life-cycle in CTIS, types of roles in CTIS, and interaction of CTIS with different database systems with diagrammatic represent and references links.

For more information, please click here.

September 2021: CTIS Training Updates

European Medicines Agency updated the page name of Clinical Trials Information System: training programme to Clinical trials information system (CTIS): online modular training programme, on September 03, 2021. The below documents were also updated in CTIS Training Module 03 (User access management) and new versions of documents were added in Module 19 (CTIS for SMEs and academia):

  1. FAQs (v1.2): User access management – Module 03: It includes questions related to the processes of self-registration, login to CTIS, basic roles and permissions in CTIS, and user profile management with answers and diagrams.
  2. Quick guide (v1.2): User access management – Module 03: It guides on the process of self-registration, steps to log in to CTIS, understand the roles and permission and in brief about user profile management.
  3. Step-by-step guide 1 (v1.0): User access management and user administration- Module 19: It provides step by step guide for registration on CTIS, viewing roles and managing user profiles. It also explains briefly about CT-centric and Organisation-centric approaches, respectively.
  4. Step-by-step guide 2 (v1.0): CTIS workload functionalities for the sponsor workspace – Module 19: It provides step-by-step guidance on how to use the workload functionalities- notices and alert tab, request for information (RFI) list tab and timetable tab along with screenshots for every step.
  5. Step-by-step guide 3 (v1.0): Search, view and download a CT and a CTA in the sponsor workspace – Module 19: It provides steps for searching, viewing, and downloading CT and/or CTA along with detailed screenshots.
  6. Step-by-step guide 4 (v1.0): Create, submit and withdraw a clinical trial application and nonsubstantial modifications – CTIS Training Programme – Module 19: It provides steps to create and submit different types of CTs (mono-national and multi-national) with screenshots for better understanding.
  7. Step-by-step guide 5 (v1.0): Create and submit an RFI response, including changes to an existing application – CTIS Training Programme – Module 19 It provides steps to view and access RFIs raised by the Member States Concerned (MSCs) during the validation and assessment phases of the evaluation of a CTA, as well as on how to create and submit the responses, and how to modify an existing CTA as part of the response.
  8. Step-by-step guide 6 (v1.0): How to manage a clinical trial – CTIS Training Programme – Module 19 It provides steps for creating different types of notification, responds to RFIs in context with ad hoc assessment, request for corrective measures and steps to submit trial results and lay summary of results.
  9. Step-by-step guide 7 (v1.0): Submit an Annual Safety Report (ASR) and how to respond to related RFIs – Module 19 It provides steps to create and submit ASR submission form, access and respond to RFIs in the context of ASR assessment.

August 2021: CTIS Webinar Update

European Medicines Agency updated the Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS event page with details pertaining to the webinar that took place on July 29, 2021.

It includes the following details provided for easy understanding of the working and functionalities of EU CTIS;

  1. Event Summary
  2. Documents inclusive of the agenda, list of speakers, and presentations over different aspects of EU CTIS
  3. Video recording of the webinar

August 2021- CTIS Highlights

The fourth issue of CTIS Highlights was published on August 06, 2021. It briefly discusses the new timeline for CTIS, confirming the go-live date of CTIS and the initial submission date followed by a three-year transition period for submission of ongoing trials through CTIS.

Additionally, the newsletter spans over the training programme updates, CTIS Sponsor handbook details, CTIS July Webinar in a word, and the importance of CTIS in harmonising the clinical trial regulatory submission process in the EU and EEA. It also fore say about another webinar that will be conducted on October 26, 2021, that will concern the preparation of CTIS from the end-user perspective. Further information on this will be provided on the EMA event page and future CTIS newsletters.

For more information, click here.

 

 

August 2021: CTIS Training Update

Dissemination guidelines for training materials: CTIS training programme

European Medicines Agency published a new guideline document related to the Clinical Trial Information System (CTIS) training programme, on August 05, 2021.

This guide is intended to support instructors in using the training materials prepared for the CTIS Training Programme. It is suggested that trainers follow a blended learning approach combining asynchronous with synchronous activities for an optimal learning experience of end-users while making efficient use of their time.

Combining the two training methods, by sharing some materials with participants ahead of a real-time training session, will ensure that participants can assimilate some contents individually and reflect on questions they may have. The training session can then be used to check participants’ knowledge absorption, address their questions, and collect input on the training materials and methodology.

For more information, refer to the guideline here.

July 2021: Clinical Trial Data Reporting in EU Countries

In Europe, the enthusiasm for trials is not matched with a zeal for reporting the results to the public. Nearly 28% of completed European trials in the EU Clinical Trials Register (EUCTR) on 1 July—had not posted their results according to the latest data from the EU Trials Tracker, set up by U.K. researchers in 2018. Public research hospitals and universities are responsible for the vast majority of the lapses, which appear to violate European rules that require sponsors to post their results within 1 year of a trial’s conclusion.

Some researchers from public trial centers aren’t keen to disclose negative results and others believe publishing results in a journal fulfills the reporting requirement, even though journal articles can come years later and are often not made public. The Public Assistance Hospitals of Paris (AP-HP), the largest clinical trial center in Europe has reported results for just one of 35 trials completed more than 12 months ago, according to the EU tracker. More than 200 of the center’s trials are listed on EUCTR as ongoing, even though more than half of them began more than 10 years ago.

The current rules stem from 2001 European guidelines are considered as “soft legislation” and some nations seem to be taking advantage. According to current French regulations, there is no obligation to post results in the EU database, their priority has been to publish both positive and negative results in peer-reviewed journals. In the Netherlands, it is sufficient if sponsors post results in the Dutch trial registry, run by the Central Committee on Research Involving Human Subjects (CCMO). The CCMO website states that sponsors must also post results of medicines trials in the EU database, but Amsterdam University Medical Center (AUMC) does not follow that rule seeing any advantage in double registrations or in doubling researchers’ administrative burden.

Europe is getting more serious about enforcing the reporting requirements. Since the launch of the EU tracker in 2018, timely reporting of results has risen from 50% to 72% of completed trials. The European Medicines Agency (EMA) has stepped up reminders to trial leaders and has sent out about 30,000 reminders to overdue trial sponsors since 2018, another possible driver of improvement. Special notices go out for COVID-19 trials.

EMA’s new trial registry Clinical Trials Information System (CTIS) launch scheduled for Jan 2022 will eventually replace the EUCTR portal after a 3-year transition period and will end the tedious process of registering trials in each participating country. Sponsors will upload all trial data, from start to finish and the relevant national regulators will review the data before the information becomes public in one, linear, straight-through process. Once CTIS goes live, a 2014 European regulation will take effect, empowering national regulators in the European Economic Area to enforce the reporting of results. It will be for governments to decide how the national regulators should enforce reporting and what penalties they should impose for lapses.

Denmark, known for its vigilant regulation of drugs and trials already has a law that allows authorities to fine or imprison clinical trial leaders who do not meet deadlines for reporting results.

Additional details are found here.

July 2021: European Commission Decision On CTIS

The European Commission has published the decision (L275) in the Official Journal of the European Union, today (July 31, 2021) announcing that the EU portal and the EU database have achieved full functionality and meet the functional specifications, as referred to in Article 82(2) of Regulation (EU) No 536/2014. This Decision shall enter into force on the day of its publication in the Official Journal of the European Union (31 July 2021).

On 21 April 2021, the Management Board of the Agency, on the basis of the independent audit report delivered on 8 April 2021, informed the Commission in accordance with Article 82(2) of Regulation (EU) No 536/2014 that the EU portal and the EU database have achieved full functionality and the systems meet the functional specifications published by the Agency.

On the basis of the information provided by the Management Board of the Agency, the Commission verified that the EU portal and the EU database fulfilled the conditions of the full functionality and of compliance with those functional specifications. For more details, please refer to the Commission Decision (EU) 2021/1240 of 13 July 2021 on the compliance of the EU portal and the EU database for clinical trials of medicinal products for human use with the requirements referred to in Article 82(2) of Regulation (EU) No 536/2014 of the European Parliament and of the Council.

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.