The Central Committee on Research involving Human Subjects (CCMOCentral Committee on Research involving Human Subjects ), the Ministry of Health, Welfare and Sport (VWSMinistry of Health, Welfare and Sport ), and the Ministry of Infrastructure and Water Management (IenWMinistry of Infrastructure and Water Management ), require mandatory submission of adverse events and unexpected circumstances. Under 'Notifications' you will find more information about what and how to notify.
In the case of gene therapy research, notification must be given if one or more of the following situations have arisen:
- All unexpected serious adverse reactions (SUSARsSuspected Unexpected Serious Adverse Reactions )
- All serious adverse events (SAEs, not being SUSARSuspected Unexpected Serious Adverse Reaction ) with the exception of SAEs that require no reporting according to the clinical protocol.
- All unexpected circumstances that may affect the environmental safety.