All adverse events arising during participation in a study or occurring in a subject must be properly documented and reported.
Serious adverse events during clinical trials involving human subjects can be divided into three categories, each of which requires 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
Researchers are obliged to report to the assessment committee all serious adverse events occurring during the study, according to and the , and within the specified time lines.
For each type of study (drug, device, other studies subject to the WMO), the website of the CCMO provides detailed information on SAEs, SUSARs and SADEs and the reporting of such events, including clear flowcharts.
The following standard procedure has been written at Amsterdam UMC for documenting, monitoring and reporting all adverse events occurring during research: GCT SOP 04 Safety Reporting.
Adverse events in research can at the same time meet the criteria for (near) incidents or calamities in Amsterdam UMC. Reporting incidents is part of the integral quality system. Incidents can be reported via the Safety Management System: I-Task. For definitions, instructions on reporting (near) incidents, see the manual in K2.