Transition to Research Portal

The Research Portal will be used to submit all medical research that falls under: 

• WMO (Medical Research Involving Human Subjects Act)
• Embryowet (Embryo Act) 
• MDR (Medical Device Regulation)
• IVDR (In Vitro Diagnostic Regulation
• national non-interventional PASS studies at the request of the MEB-CBG
• the DCRF's non-WMO review framework.  

Other non-WMO research can be registered through this portal. This registration is not mandatory.

Thus, the scope of the new portal will be wider than that of the current ToetsingOnline.  

• For users, the new system will be plainer and more efficient, because registering and submitting a study can now be handled in a single procedure. Previously, different submission procedures might have to be dealt with.
• The system will lead you through the process step by step, in the end determining which review committees you can choose for reviewing your research. All required documents can be attached with the submission.
• Research falling under the DCRF review framework and national and non-interventional PASS-studies at the request of the CBG can also be registered and submitted through the new system.
• In addition, the new system may also be used to register for publication other non-WMO-studies (non-WMO-studies not falling under the DCRF review framework of national non-interventional PASS-studies at the request of the MEB-CBG). 

After having been processed in the Research Portal, both WMO-studies and non-WMO-studies will be automatically published in the Overview of Medical Research in the Netherlands (OMON) and the International Clinical Trial Registry Platform (for short: ICTRP) of the World Health Organization. With a publication in this overview,  the requirements for publication in scientific journals are met. This means that registration in other acknowledged registers is no longer required. 

• In November 2024 training materials will be available 
• ToetsingOnline will be available until 24 January 2025, 5 p.m.. The Research Portal will be available from 3 February 2025. In the intervening period it will not be possible to submit any studies. 
• ToetsingOnline will still be in use for handling ongoing assessments after the Research Portal is online. In the course of 2025 ToetsingOnline will be taken offline.  

If your study is still being assessed when the Research Portal comes online, the assessment will be concluded in ToetsingOnline. Your study will be transferred to the new Research Portal. After approval you will make all further amendments or modifications in the Research Portal. 

All studies that have been positively assessed and have not yet been concluded, will be transferred from ToetsingOnline to the new portal. Should you wish to submit a new amendment or modification after the Research Portal has come online, you will have to do so in the new portal. Ongoing assessments of amendments that have been submitted in ToetsingOnline will be concluded there. 

Ongoing trials with medicinal products submitted in ToetsingOnline will not be migrated to the Research Portal. You are to transfer these trials to CTIS yourself. For more information: Transition trials: CTD to CTR | Investigators | The Central Committee on Research Involving Human Subjects (ccmo.nl). If you have not yet transferred your trials with medicinal products it is important that you do so as soon as possible. 

Research that has ended before 31 January 2025 but has not been concluded as yet will not need to be transferred tot CTIS, but will be migrated to the new Research Portal for conclusion. If the results have been included in ToetsingOnline or the final end-of-study date has expired for over 3 years, the study will not be transferred to the new Research Portal. 

Studies that have been concluded will not be migrated to the new portal. Studies are considered to be concluded when the results have been entered in ToetsingOnline or if the end-of-study date has expired for over 3 years. 

You may submit new studies according to the current procedures. ToetsingOnline will be available until the Research Portal will come online on 3 February 2025, except for a few days needed tot migrate dossiers. This will take about three days; during these days you cannot submit any studies. 

If you already know you will submit a study after the Research Portal has come online, you are advised not to fill out an ABR form in ToetsingOnline in advance, as draft ABR forms cannot be transferred to the new portal. 

In preparation for the new way of submitting studies,  a sample ABR form is availble showing you the questions to be answered for a submission in the Research Portal. Please note: this form is only a representation of the questionnaire to be completed online. It cannot be filled out or submitted in the present form.