Safety reporting forms for clinical research projects

High-quality safety reporting from start to finish

What it is:

This set of comprehensive safety reporting forms addresses the handling of serious adverse events (SAE) and the preparation of the annual safety report (ASR). It includes:

• Serious Adverse Event Report Form for Investigational Medicinal Products (IMPs)
• Serious Adverse Event Report Form for Other Clinical Trials
• Serious Adverse Event or Device Deficiency Report Form for Investigational Medical Devices (IMDs)
• Serious Adverse Event or Device Deficiency Report Form for Vitro Diagnostic Medical Devices (IVDs)
• Serious events (SE) form for research projects not involving clinical trials (HRO)
• Annual Safety Report Template (Version 2.1 in collaboration with swissethics)

What it can do:

These new forms guide you through all aspects of safety reporting. They help you collect, assess and report appropriately any serious adverse event (SAE) that occurs during your clinical research project and guide you in the preparation and submission of the annual safety report (ASR). The forms are tailored to each type of clinical research. In addition, they provide instructions on what exactly needs to be completed as well as information on the relevant Swiss legal basis.

Who should use it:

These forms can be used by any investigator performing clinical research in Switzerland, in particular sponsor-investigators.

​Who is behind this resource:

These templates were developed by the SCTO’s Safety Platform and first published in May 2021. The Annual Safety Report Template was created through a collaborative effort with swissethics.