28 November 2025

Validated solution for structured safety data

The Data Management Platform of the Swiss Clinical Trial Organization (SCTO), together with the DKF Basel and the Centre de Recherche Clinique of the University of Geneva, has introduced an established and validated tool for clinical research: the MedDRA Converter for secuTrial®. This tool enables the seamless integration of MedDRA coding into the secuTrial® electronic data capture system.

Why is this important?

In clinical trials, safety data - such as Adverse Events (AEs), Serious Adverse Events (SAEs) and medical history information - should be recorded in a standardized way. This allows the data to be reliably compared and evaluated by sponsors, Data and Safety Monitoring Boards (DSMBs), investigators and authorities. The internationally established solution for this is MedDRA (Medical Dictionary for Regulatory Activities) - the official standard in accordance with the ICH guidelines.

The MedDRA version files provided by the Maintenance and Support Services Organization (MSSO) cannot be imported directly into secuTrial®. The converter solves this problem: it converts the original MSSO files into a secuTrial®-compatible format. The tool was validated together with the DKF's Quality Affairs team.

Safety Management Service at the DKF

For research groups, the DKF offers to take over the MedDRA coding as part of the Safety Management Service. This service supports research groups in the structured collection, coding and evaluation of safety data. Further information can be found here On Site & Safety Management at the DKF.

Availability

The converter is available free of charge for the entire SCTO network and represents an important step towards harmonized and high-quality data in Swiss clinical research.

For further information, please contact Tanja Litke, PhD (Senior Data Manager DKF and SCTO Data Management Platform Coordinator).