Our validated tool makes it easy to code Adverse Events and Medical History directly within secuTrial® databases using MedDRA. Instead of searching terms in the MSSO Web-Based Browser and manually copying them into the system, coding can now be performed directly in secuTrial®. This saves time, reduces manual errors, and ensures that all clinical trial data is stored in one place. The tool is freely available across the SCTO CTU network—supporting more efficient, interoperable, and reliable clinical research. If you would like MedDRA coding to be integrated into your database, please contact your CTU Data Managers for support.

This guidance document provides practical recommendations for fulfilling the regulatory requirements and safety reporting obligations applicable to Category A clinical trials on Investigational Medicinal Products (IMPs) in Switzerland.

harmBounds R Package calculates stopping probabilities, defines stopping boundaries, and produces plots for safety monitoring using a simple event-based approach. The package supports safety interim analyses during trial conduct. Further development toward a broader vignette on safety interim analyses is being considered.

This online training will provide you with an overview of definitions, requirements, and procedures related to safety management in clinical research.

This online training will provide you with an overview of definitions, requirements, and procedures related to safety management in clinical research.

This document can be used for Serious Adverse Event (SAE) or Device Deficiency (DD) reporting in Clinical Trials with an Investigational Medical Device (IMD).

This document can be used for Serious Adverse Event (SAE) or Device Deficiency (DD) reporting in Clinical Trials with an In Vitro Diagnostic Medical Device (IVD).

This document can be used for Serious Adverse Event (SAE) notifications in Clinical Trials with an Investigational Medicinal Product (IMP).

This document can be used for Serious Adverse Event (SAE) notifications in Other Clinical Trials.

The finder connects you directly to skilled safety experts throughout Switzerland and provides an overview of all aspects that are relevant for safety management in a clinical study.