Template research protocol amended

The template research protocol has been changed, due to the upcoming replacement of ToetsingOnline by the new Research Portal on 3 February 2025 and the end of the transition period for trials with medicinal products on 30 January 2025. 

From November 26 2025 the adapted Template research protocol is available for submissions falling under WMO, Embryo Act, MDR of IVDR.

What exactly has been changed?

1. SAE’s must be submitted in the Research Portal and can no longer be submitted in ToetsingOnline.
2. All references to trials with medicinal products (e.g. to SUSAR’s) have been removed. For trials with medicinal products a separate template research protocol is available.
3. In some instances, examples have been moved from the instruction balloons to the main text.

When your present protocol has already been approved and still refers to ToetsingOnline, this may be corrected with the submission of a subsequent amendment. To cover the period preceding the amendment or in the case no amendments will be made, a Protocol clarification/Note to file may be drawn up, explaining that safety reports will be submitted in the Research Portal as from 3 February 2025.

For more information about the transition from ToetsingOnline to Research Portal, consult the CCMO website.