On this page, you will find an overview of where to submit each type of information in the Research Portal. You will also find user guides for the Research Portal. If you have any questions, please consult the FAQ's and helpdesk page. To get an general impressions of the Research Portal, you can watch a short introductory video.
Where do you submit what?
Below is an overview showing, for each type of information, where it should be submitted within the Research Portal and which party is responsible for processing it. The table under 'Submission Route' shows which tab and button to use to submit the information.
Type of information
Submission route
Processed by
Amendments
Submission → Amendment
Review committee (MREC or CCMO)
Appeal to a decision by an MREC
Other notifications → Notification
CCMO
Decision to early terminate a study (follow up ongoing)
Other notifications → Notification
Review committee (MREC or CCMO)
Deelnemend centrum toevoegen
Submissions → Amendment
Review committee (MREC or CCMO)
Early termination
Progress → Status progress
Review committee (MREC or CCMO)
Early termination part of study
Other notifications → Notification
Review committee (MREC or CCMO)
End of recruitment
Progress → Status progress
Review committee (MREC or CCMO)
End of study in The Nederland
Progress → Status progress
Review committee (MREC or CCMO)
End of study worldwide
Progress → Status progress
Review committee (MREC or CCMO)
Expected end date change
Submissions → Amendment
Review committee (MREC or CCMO)
Expected start date change
Submissions → Amendment
Review committee (MREC or CCMO)
Initial submission
My research → Add research
Review committee (MREC or CCMO)
Line listing of SAEs
SAE → SAE
Review committee (MREC or CCMO)
MDCG form
SAE → SAE
Review committee (MREC or CCMO)
Objection to a decision by the CCMO
Other notifications → Notification
CCMO
Objection to disclosure of core data in OMON
Other notifications → Notification
CCMO
Objection to disclosure of results in OMON
Other notifications → Notification
CCMO
Progress report
Progress → Progress report
Review committee (MREC or CCMO)
Protocol deviations impacting the safety of the participants or data integrity
Other notifications → Notification
Review committee (MREC or CCMO)
Request to extend decision
Other notifications → Notification
Review committee (MREC or CCMO)
Restart after temporary halt
Progress → Status progress
Review committee (MREC or CCMO)
Restart part of the study
Other notifications → Notification
Review committee (MREC or CCMO)
SAE individual report
SAE → SAE
Review committee (MREC or CCMO)
Signed clinical trial agreement
Submissions → Amendment
Review committee (MREC or CCMO)
Start date (inclusion of first participant)
Progress → Status progress
Review committee (MREC or CCMO)
Start of recruitment
Progress → Status progress
Review committee (MREC or CCMO)
Studieresultaten
Results → Research result
Review committee (MREC or CCMO), CCMO responsible for publication in OMON
Study will not start in The Netherlands
Progress → Status progress
Review committee (MREC or CCMO)
Temporary halt
Progress → Status progress
Review committee (MREC or CCMO)
Temporary halt part of the study
Other notifications → Notification
Review committee (MREC or CCMO)