In clinical practice, an objective of safety management is to identify preventable causes of adverse events to avoid the incidents from recurring. Likewise, in the field of clinical research adequate methods to investigate incidents that impair the quality of a clinical trial are needed. Understanding the causes of errors and undesirable incidents can help guarantee participant safety, improve the practices of research coordinators, investigators, and clinical research assistants and help to minimize research costs. Here, we present the main features of our Incident Feedback Committees (IFC) in clinical research, with outcomes over 5 years.
Methods: The IFC has adapted the ALARM and ORION post-event methods with investigations focused on 'the incidents' occurring during research studies. It sought the root causes contributing to these incidents and proposed corrective actions.
Results: Since our IFC was set up in 2015 it has examined 52 incidents from nine studies. The most frequent causes mainly concerned the working environment (54%). Most incidents had two or more causes. Some corrective actions were planned for ongoing or future studies.
Conclusion: IFCs provide a useful and much-appreciated method of analysing incidents in the performance of clinical research. A multicentre study is needed to evaluate the effect of IFCs on the quality of an establishment's clinical research, at the individual level (patient safety) and also at the system level (changes in the organization of tasks).
Keywords: clinical research; quality improvement; root cause analysis.