What is the procedure?

SAE

Phase 1 and 2 research:

SAEs that have resulted in death or are life-threatening must be reported to the MREC within 7 days after the responsible person has become aware of them. All other SAEs within 15 days. You must justify the inclusion of certain SAEs in periodic overview lists in the protocol.

Phase 3 research:

For phase 3 research you can report the SAEs via the same procedure as for phase 1 and 2 research, however the minimum requirement is an annual safety report. For phase 3 research it is not necessary to justify why an annual safety report is chosen.

SUSAR

SUSARs that have resulted in death or are life-threatening must be reported to the MREC within 7 days after the responsible person has become aware of them. All other SUSARs within 15 days. No distinction is made in this respect at the phase of the research.

In addition, a six-monthly safety report (SSLL) and an annual safety report (DSUR) are mandatory.

In case SAE/SUSAR incidents raise questions we will contact you.

SAEs/SUSARs are submitted from the date of submission of the investigation file to the end of the investigation in the Netherlands. The end of the study is usually the last visit of the last patient, unless otherwise specified in the study protocol.

What should I submit? 

You can send an SAE/SUSAR report by email in attachment(s) to info@stbebo.nl.

What should I pay attention to? 

Any exceptions to the notifiable SAEs or SUSARs should be described in the study protocol.

You send all national and international reports of a study to the MREC.

SUSARs that occurred in other studies with the same study drug must also be reported within the legal timeframes of 7 or 15 days. This applies to reports that can affect the safety of the subjects participating in research that has been reviewed by BEBO. All other reports should be included in a (semi) annual safety report.