Below update was posted on ClinicalTrials.gov What’s New section on September 16, 2021:
Webinar on ClinicalTrials.gov Modernization: Join us on October 7, 2021, from 1:30 to 2:00 p.m. ET for an update on the ClinicalTrials.gov modernization effort. Please register via the ClinicalTrials.gov webinar registration page to learn more about the modernization efforts and information on the anticipated launch of beta ClinicalTrials.gov. A recording of the webinar and slides will be made available for those who cannot attend live.
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.
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):
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
New Application (VO) Form and New Format for Authorisation Applications and Changes/Notifications/Reports Regarding Clinical Trials with Medicinal Products as of 13 September 2021
According to an update posted by Swissmedic (Swiss Agency for Therapeutic Products), authorisation applications and changes/notifications/reports regarding clinical trials with medicinal products must be submitted to structure (“eDoc” structure), a new application form (“VO form”), and to a new address for submissions from 13 September 2021. Any submissions according to the old submission procedure will be deemed to be formally deficient. However, purely paperless submissions will not yet be possible as of 13 September 2021 and will be implemented at a later date. Therefore, the submissions would still be made on paper and on CD even after 13 September 2021, confirming that the files on the CD are identical with the paper documents.
For more information on the documents and instructions needed for the new procedure, please refer Clinical Trials on Medicinal Products.
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;
- Event Summary
- Documents inclusive of the agenda, list of speakers, and presentations over different aspects of EU CTIS
- Video recording of the webinar
The Good Pharma Scorecard is an initiative by the Bioethics International organization that ranks companies and new medicines on their clinical trial transparency and data-sharing performance, taking into account ethics and legal standards. This scorecard is published by Bioethics International every two years.
The Good Pharma Scorecard for 2021 is now available on their website. The companies with a 100% transparency score, for their clinical trial transparency, with the first ranking on the scorecard are AbbVie, Amgen, Bayer, Merck KGaA / EMD Serono, Novartis, Roche / Genentech, and Takeda. Under the data sharing section companies with a 100% data sharing score are AbbVie, Amgen, AstraZeneca, Bayer, Johnson & Johnson / Janssen, Merck KGaA / EMD Serono, Novartis, Novo Nordisk, Roche / Genentech, Shire, and Takeda.
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.
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.
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.
An update was posted on the DRKS website on July 29, 2021, regarding the Universal Trial Number (UTN) application. UTN of the World Health Organization (WHO) can now be reached under a new link.
The WHO issues a UTN to each clinical trial upon request.
A UTN is a unique number that is generated by the WHO for every clinical trial that is registered in one of the WHO primary registries. It is intended to facilitate the identification of studies and is displayed on the WHO International Clinical Trials Registry Platform (ICTRP) search portal. As soon as the first version of the study protocol has been created, a UTN can be applied for free and easily via the WHO platform. UTN is included as a secondary ID in DRKS.
The post also includes reference links for UTN and FAQs on UTN.