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.
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.
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:
- 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].
- 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.