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 (non-WMO research initiated and/or sponsored by pharmaceutical companies).

Other non-WMO research can be registered through this portal (for more information consult Publication on this page). 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). 
• A sheet is avaible summing up the main differences per type of research.

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 January and February 2025 webinars will be hosted for future users. They will include a presentation of the Research Portal and a demonstration of several steps in the submitting procedure.
  The webinars are scheduled for: 
  Tuesday 7 January (NL) 10:00 – 11:00 
  Thurdsday 9 January (EN) 15:00 – 16:00 
  Thursday 6 February (NL) 16:00 – 17:00 
  Friday 7 February (EN) 10:00 – 11:00 
  Participation is free. You may register for one of the webinars by filling in the registration form.
• ToetsingOnline will be available until 24 January 2025, 17:00. 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. 

Files that will not be migrated to Research Portal:

• Files with draft ABR only
• Files for which final ABR exists but which has not been submitted
• Negatively assessed files without the possibility to object (more than 6 weeks after date of decision)
• Files with the indication ‘will never start’
• Files with final end date more than 3 years ago
• Files not started within 5 years of positive review
• Files with planned end date more than 4 years ago
• Research with a medicinal product not involving a combination with MDR/ IVDR that have been transferred to CTIS (Transition Studies) 

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 and amendments according to the current procedures. ToetsingOnline will be available until 24 January 2025, 17:00. As from 3 February 2025 the Research Portal will be available. During the intermediate period you cannot submit any studies or amendments. 

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.

From 24 January 2025 until 02 February 2025 it is not possible to report SAEs in ToetsingOnline.

• SAEs received before January 24 2025: report in ToetsingOnline
• From February 3 2025: report in Research Portal
• Only when the legal deadline of notification falls in the period when ToetsingOnline is unavailable, there is a temporary change in reporting procedure:
  • Send the SAE to the review committee by email. A notification form (add link) is temporarily available specifically for this purpose.
  • From 03 February 2025, you also submit the SAE via the Research Portal and indicate that you have previously reported this SAE to the review committee by email. Carrying out these instructions iis important to ensure that you can report follow-ups to this SAE in the future. For individual SAEs, you can indicate this in the Summary field. For an SAE notification via the MDCG form, you can indicate this in the Conclusion field.