December 2021: Netherlands Update

New online tool provides insight into the scope of CTR

The CCMO on December 23, 2021, has released an update to provide information about the Clinical Trial Decision Tool which was jointly developed by the Paul Janssen Futurelab and the CCMO.

The new Clinical Trial Decision Tool helps determine whether the drug research falls within the scope of the Clinical Trial Regulation (CTR). The CTR will become applicable in the European Union on January 31, 2022.

After answering a maximum of 13 questions, the Clinical Trial Decision Tool shows whether or not the research falls within the scope of the CTR. The tool also shows whether that is a low-intervention clinical trial. Adapted rules apply to such research.

For more information, follow this link.

December 2021: In Vitro Diagnostic Medical Devices Regulation Update

European Commission provided an update regarding the Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation on December 20, 2021:

The update mentions that the ‘In Vitro Diagnostic (IVD) Medical Devices Regulation’ can now be progressively rolled out, after its adoption by the European Parliament and the Council to ensure there is no shortage of essential medical devices and will come into force from May 26, 2022, as planned.

Keeping into consideration the high paucity of the notified bodies, it also notifies about the amendment to the IVD Regulation of 2017, that has changed the dates of application of some requirements for certain essential medical devices.

  • Higher risk devices (class D): New requirements will apply from May 2025
  • Lower risk devices (class C): The date of application is extended until May 2026
  • Lower risk class devices (class B and A sterile): Application starts in May 2027
  • In-house devices: Delayed by two years until May 2024

It also mentions that the transitional periods will come to an end in May 2028, if the unavailability of an equivalent device on the market is proved by the health institutions. However, no change is proposed for ‘new-devices’ or CE-marked devices that do not require notified body involvement, for these devices the IVD Regulation will apply from May 26, 2022.

For more information, please click here.

December 2021: Netherlands Update

Dutch Institutions Finally Make Progress on Clinical Trial Reporting

As per the news article posted on TranspariMED on 14-Dec-2021, over 700 clinical trials run by the ten largest Dutch institutions are still missing results, but major institutions are now working to fix the problem, new data suggest.

Full results are publicly available on the European trial registry for only 52 clinical trials run by the Dutch cohort, less than 7% of all due trials. This is still far below the European average reporting rate of 28% for major non-commercial trial sponsors.

The country’s largest sponsor, Radboudumc, has the strongest transparency record with 21 reported trial results, while estimated 102 Radboudumc trials are still missing results or are not marked as completed and 124 trials are not yet due to report results.

On the positive side, nearly all major Dutch institutions have uploaded additional results over the course of 2021. Between February and November 2021, Radboudumc uploaded 10 due trial results as part of an ongoing systematic effort to clear its backlog of unreported trials. Erasmus University uploaded 6 additional due results. Only HOVON Foundation has made no visible progress.

Netherlands may finally be starting to catch up with the rest of Europe in terms of clinical trial transparency.

For additional details, please follow this link.

December 2021: CTIS Training Update

European Medicines Agency (EMA) updated the pages Clinical Trials Information System: training and support and Clinical Trials Information System (CTIS): online modular training programme on December 16, 2021, by adding the below documents:

  1. Clinical Trial Information System (CTIS) structured data form – Annual Safety Report (ASR): This document provides guidance on the data fields Sponsors will have to fill in CTIS when creating an ASR and also contains screenshots of different sections of the system (CTIS software version 0.18.35.3).
  2. Clinical Trial Information System (CTIS) structured data form – Request for information (RFI): This document provides guidance on the data fields Sponsors will have to fill in CTIS when responding to an RFI and also contains screenshots of different sections of the system (CTIS software version 0.18.35.3).
  3. Clinical Trial Information System (CTIS) list values: This document contains the terms of all the lists present in the CTIS structured data forms for an initial application (IN), additional MSC application, substantial modification, and non-substantial modification applications, notifications, ASR, and RFIs.
  4. Step-by-step guide: How to manage a CT – Module 05: It provides a stepwise guidance to create notifications, respond to RFIs, respond to request for opinion regarding corrective measures and to submit trail results and results summary for lay person.
  5. Quick guide: How to manage a CT – Module 05: It provides information on the four system functionalities i.e. notifications, RFIs raised, results summary and summary for lay person along with CTIS insights.

Also an updated version of FAQs: How to create, submit and withdraw a Clinical Trial Application – Module 10 was uploaded with an addition of Section 7-Roles and Permission.

December 2021: CTIS Training Program

European Medicines Agency updated about the upcoming event Clinical Trials Information System sponsor user training program over the What’s New Section on December 16, 2021:

The event page notifies about EMA’s plan to conduct six different virtual training courses as part of the training program for sponsor users and the dates on which these courses will be conducted throughout the year 2022 to support sponsor user preparedness, guide on submitting a clinical trial application, and managing the life cycle of a clinical trial in the European Union (EU) and European Economic Area (EEA).

The first sponsor user training course will be conducted from January 24, 2022, to January 27, 2022, for the clinical trial sponsors. The event page also provides a list of components that must be completed before participating in the program along with the topics that will be covered during the virtual live program.

A registration link has been provided for interested sponsor users to participate in the first sponsor user training course.

For more information, please click here.

December 2021: CTIS Training Update

European Medicines Agency updated the page Clinical trials information system (CTIS): online modular training programme, on December 14, 2021, by adding the new versions of the below documents:

  1. Step-by-step guide: Create, submit and withdraw a clinical trial application and nonsubstantial modifications – Module 10: It explains the different types of clinical trial applications (CTA), non-substantial modifications and steps required for creating, submitting and withdrawing it.
  2. Step-by-step guide: How to respond to requests for information received during the evaluation of a Clinical Trial Application – Module 11: It provides stepwise guidance for sponsor users to view and access right for information (RFI) raised by member states concerned (MSC) and to create, modify an existing CTA and submit a response.
  3. FAQs: Union Controls in CTIS – Module 21: It provides answers to general questions regarding Union Controls, its reports, plans/programmes, roles and permission.
  4. Step-by-step guide: Union Controls in CTIS – Module 21: It provides stepwise guidance to create and share plans/programmes for Union Controls and also to create, submit, view, download, update and withdraw Union Control reports.
  5. Quick guide: Introduction to CTIS for public users – Module 22: It provides an overview of the CTIS public website and stepwise guidance for public users to search, view, and download information of a clinical trial (CT). It also provides steps to view the Union Control reports.
  6. FAQs: Introduction to CTIS for public users – Module 22: It provides answers to questions regarding CTIS public website, its different search functionalities, view and download CTs and CTAs information, and Union Controls.

Also, an updated version of the Guide to CTIS training material catalogue was uploaded with the addition of ‘Module 24: Business Intelligence Reporting’ in the list of modules and general CTIS information.

December 2021: CTIS Training Update

European Medicines Agency updated the page Clinical trials information system (CTIS): training and support, on December 13, 2021, by adding the below document:

Getting started with CTIS: Sponsor Quick guide- It provides step-wise guidance for the sponsors to select one of the user management approaches i.e. organization-centric approach or trial-centric approach and complete registrations required in both the approaches for the submission of clinical trial application.

For more information, please click here.

December 2021: CTIS Highlights

The sixth issue of CTIS Highlights was published on December 13, 2021. It provides certain preparatory steps to be taken by the sponsor before using CTIS, discusses the upcoming events and training material to be updated in early 2022.

It reminds all future CTIS users without an EMA account to register for an EMA account as soon as possible. It also reminds the sponsor organizations opting for the organization-centric approach to register in EMA’s organization management system (OMS) along with their first high-level administrator, the sponsor administrator, via EMA account management before using CTIS, if not registered yet. The clinical trial sites that routinely participate in clinical trials are advised to register in OMS to facilitate submission of clinical trial application (CTA).

It briefly discusses EMA’s plan to host ‘CTIS Talks’, an upcoming event explaining CTIS key functionality areas. In this event, participants will get an opportunity to ask questions to CTIS experts. More details about the event will be provided shortly.

The newsletter also notifies that along with the 20 CTIS training modules that are currently available, revisions of the existing modules and new modules including introduction to CTIS for public users, management of union controls by European Commission, and transition of clinical trials from directive to regulation will be published in the upcoming year of 2022.

It mentions that the respondents of the survey provided in the previously issued newsletter regarding self-assessment and interest in accessing the training environment will be contacted directly in December 2021. It also discusses, in brief, the sponsor end-user training that will start next year and the recently updated version of the CTIS Sponsor Handbook.

December 2021: CTIS Training Update

European Medicines Agency updated the page Clinical trials information system (CTIS): online modular training programme, on December 10, 2021, by adding the below document in CTIS Training Module 03 (User access management):

Quick guide: User access management – It explains in brief the significance of the OMS portal and steps to access the guidance documents available on the portal. It also includes step-by-step guidance for searching an organization, creating a new organization and updating an existing organization with screenshots and CTIS insights.

For more information, please click here.

December 2021: Netherlands Update

Transition from NTR to CCMO

Some additional information is available in continuation to the service announcement displayed on the Netherlands Trial Registry (NTR) website:

  • It is currently not possible to register a new study with the NTR since it is permanently closed for new study registrations
  • The NTR will get a restart with the Central Committee on Research Involving Human Subjects (CCMO) registry. The new Dutch Trial Register is not yet available and there is no clarity as to when it will go live
  • New studies cannot be registered in the NTR during the transition phase, however, studies already registered in the NTR will be included in the New Trial Register and the registration number (NL XXXX) can continue to be used when publishing the study in a scientific journal
  • In addition, as a researcher it remains possible to make changes to already registered studies in NTR
  • It is further advised to register studies with another WHO recognized registry, such as ISRCTN Registry or Clinicaltrials.gov

For more details, please follow this link.