October 2021: Netherlands Update

Online symposium on EU Clinical Trial Regulation on 11 November 2021

An online symposium on the EU’s Clinical Trial Regulation (CTR) will take place on November 11, 2021, which will come into effect on January 31, 2022.

The symposium will provide more information about the procedures that will apply to various parties under the CTR, such as doctors, science offices, CROs, pharmaceutical companies, the CCMO and the accredited MRECs.

The symposium is organized by Association of Clinical Research Organisations in the Netherlands (ACRON) in collaboration with the Dutch Clinical Research Foundation (DCRF) and its partners.

Follow this link to the Registration Form.

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.

May 2021: Netherlands Regulatory Update

Information Regarding EU Medical Devices Regulation Available on the CCMO Website

The Central Committee on Research Involving Human Subjects (CCMO) announced the availability of a special theme page for clinical research on medical devices on May 20, 2021. Also, the ToetsingOnline submission portal is expected to be adapted to the requirements of the MDR on May 25th. Research that falls within the scope of the MDR must be registered in the new release of ToetsingOnline.

Until the European portal, Eudamed is functional all research involving medical devices must be submitted via ToetsingOnline. The study must be registered by filling in the ABR form (version May 2021) online in ToetsingOnline. Also, to register in the future Eudamed, a Eudamed form has been made available, which is mandatory from May 26, 2021, for clinical investigations that fall under Article 62 or 74 of the MDR.

Additionally, the requirements for reporting the results of a clinical study with medical devices are provided as below:
  1. Results of research for conformity purposes (MDR article 62 or 74.2) or post-market clinical follow-up (PMCF) investigations (MDR article 74.1):
    • As per MDR, the sponsor must submit a clinical study report and a summary of results for the layperson within one year of the end of the study.
    • For prematurely ended studies, the investigation report and the lay summary must be submitted within 3 months.
    • As soon as Eudamed is operational, the sponsor must upload the results of the investigation into Eudamed and the investigation report and the lay summary will be made public via Eudamed.
    • However, as long as Eudamed is not operational, the research report and lay summary must be immediately submitted to the CCMO (along with the review committee) via [email protected].
  2. Results of other clinical research (MDR article 82):
    • Summary results must be submitted within one year of the end of the study to CCMO.
    • The results of the research will be published in the CCMO register 15 days after upload unless the client has objected to this with reasons.

For more information on this, please refer to the post on the CCMO website here.

April 2021: Netherlands Regulatory Update

On May 26th 2021, the European Medical Device Regulation (EU) 2017/745 (MDR) will apply resulting in changes in rules for the submission, assessment and conduct of clinical investigations with medical devices. Thus, the Central Committee on Research Involving Human Subjects (CCMO) has published a set of additional information under Research with medical devices from May 26, 2021.
CCMO has also made available some of the main changes as a result of the MDR. One of key changes reported is that a European portal, Eudamed, is under construction and is expected to be fully functional in 2022. In this portal, all relevant information concerning medical devices is registered, including the registration of clinical investigations. Clinical Trials conducted in the Netherlands are to be submitted on ToetsingOnline until Eudamed becomes functional. Also, the CCMO will be the competent authority for clinical investigations.

For more details on the above updates please refer to the post Research with a medical device from 26 May 2021 on the CCMO website.