Safety reporting
- WMO
All adverse events occuring during a study or affecting a participant must be properly documented and reported in accordance with the study protocol, as well as applicable legislation and regulations, ensuring adherence to specified timelines.
Serious adverse events (SAEs) in medical scientific research are categorized into three groups, each requiring a different method of reporting:
- AE: Adverse Event / AR: Adverse Reaction / ADE: Adverse Device Effect
- SAE: Serious Adverse Event / SAR: Serious Adverse Reaction / SADE: Serious Adverse Device Effect
- SUSAR: Suspected Unexpected Serious Adverse Reaction / USADE: Unexpected Serious Adverse Device Effect
The CCMO website provides comprehensive information (including flowcharts) on the reporting procedures for each study type: medicinal products, medical devices, other studies subject to the WMO.
At Amsterdam UMC, the standard procedure for documenting, monitoring, and reporting all adverse events in medical scientific research is outlined in GCT SOP 04 Safety Reporting. Information on local procedures is also available on the MREC website.
Adverse events in medical scientific research may also meet the criteria for (near) incidents or calamities within Amsterdam UMC. Reporting such incidents is part of the institution's integral quality system. Incidents can be reported via the Safety Management System: I-Task. For definitions and instructions, refer to the manual in K2.