Clinical trial complexity has grown, leading to global efforts to improve quality and safety through risk management (RM). However, clear guidelines for RM at Institutional Review Boards (IRBs) are lacking. This study describes the development and implementation of an RM process within an IRB, focusing on a quantitative risk assessment tool.

The RM process followed ISO 31000 guidelines. Risk assessment was performed using quantitative and qualitative strategies; for the quantitative strategy we developed an online tool (InRisk_Tool) with variables selected using the systematic team approach; analysis was conducted using the semi-quantitative method of risk indexes and the probability-impact matrix. Additionally, IRB members performed the qualitative analysis of each study. Risk treatment activities were implemented mainly according to the risk level established by the InRisk_Tool.

The InRisk_Tool comprises 20 variables categorized into two dimensions: Probability and Impact. Categorical variables scored 0 for negative responses and 1 for positive ones. Quantitative variables also scored 0 or 1 based on the number of events. The scores for Probability and Impact ranged from 0 to 14 and 0 to 6, respectively. These scores were categorized into three levels: High, Intermediate, and Low. Combined scores formed a probability-impact matrix to determine overall risk levels.

The InRisk_Tool provides systematic, objective risk evaluation for clinical trials. Further refinements and artificial intelligence integration could enhance scoring, analysis, and decision-making, strengthening patient safety.