FAQ's and helpdesk

If your study was still being reviewed when the Research Portal came online, the review will be concluded in ToetsingOnline. After this, your study will be deblocked within the new Research Portal. After approval you will make all further amendments or modifications in the Research Portal. 

In case of several ABR versions in ToetsingOnline, the migration was done based on the active version of the ABR from ToetsingOnline. Not all data fields were migrated, the data must be supplemented with the next amendment 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. 

If, during the switch between the two portals, you reported an SAE via email, you are required to follow this up with a submission in the Research Portal.

When submitting this SAE, indicate that you have reported it earlier to the review committee. This is important to ensure that you will be able to report future follow-ups to this SAE. You can enter individual SAE's in the field Summary. A reported SAE via the MDCG form can be entered in the field Conclusion.

No, this is not possible. The system works with individual accounts and two factor authentication. It is possible, however, to give your colleague access to your file. In the ABR form you may submit the email address of the contact for the review committee as well as a cc email address to be used for all communications about a research file.

It is not possible to authenticate without a smartphone.

Every user with the role ‘basis’ or ‘complete’ is entitled to do all submissions in the Research Portal, with the exception of SAEs. These can only be submitted by the user with the roles ‘complete’ or ‘SAE’.

If a user must remain blinded, this user should be assigned the role ‘basis’. The log shows which users have authorizations.

The Research Portal is not designed for research falling under the Clinical Trial Regulation (CTR). This involves trials with medicinal products, which are completely handled in CTIS. Only studies not falling under the CTR are handled in the Research Portal. This entails studies falling under the WMO (Medical Research Involving Human Subjects Act), the Embryo Act, MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation).

Yes, there is. This template research protocol is available as a download. It is applicable for research falling under WMO, Embryo Act, MDR and IVDR.

A partly filled out research file with a portion of the documents may be saved as a concept to be completed later.

The submitter receives a reminder email for submitting the annual progress report.

Yes, there is a 50 Mb maximum per document.

The submitter receives a reminder email:

• When the deadline for a request for information will expire
• When a start date is required
• When the end date is approaching
• When the decision expires 

When the Research Portal goes live the decision letters will not be included in the Research Portal; the review committee sends these letters directly to the contact and the cc mentioned in the ABR, bypassing the Research Portal. Possibly, the decision letters will be included in a later release of the Research Portal.

In the Research Portal, the questions from the ABR are integrated into the system. When you start a primary submission or amendment, you will see the different sections (Section 1 to 11), after submission you will receive the submitted ABR form in PDF format in your email box. 

In section 12 Documents in the Research Portal, you add all documents that need to be submitted. The MREC receives all documents via the Research Portal.

The structured data that are published are marked with a globe in the Research Portal. In addition the summary of the results (M2a) is published.

In OMON, personal data of contacts will be published for scientific questions and general questions. This is mandatory on behalf of the WHO. The submitter is responsible for obtaining permission from the contacts for publishing their personal data.

For nWMO studies the Research Portal can only be used for registration in order to publish the data before the study starts. These studies cannot be submitted in the Research Portal, nor can a not WMO-declaration be issued through the portal. There are a few exceptions: nWMO studies falling under the DCRF review framework  (www.nwmostudies.nl) and national PASS studies at the request of MEB. These are to be submitted in the Research Portal.