To analyze the current situation and causes of protocol violations in pediatric drug clinical trials, develop strategies to prevent and reduce them, and provide a reference for standardized implementation of pediatric drug clinical trials.

Cases of protocol violations in pediatric drug clinical trials at a Grade Ⅲ Level A specialized women and children's hospital from January 2022 to June 2025 were collected. A retrospective analysis of the types of protocol violations, responsible entities, and specific causes was performed, and targeted improvement measures were formulated accordingly.

Across 24 pediatric drug clinical trials, a total of 186 occurrences of protocol violations were recorded. The primary types included sample-related violations, visit-related violations, medication-related violations, and examination/test-related violations. When classified by the responsible entity and ranked by frequency of occurrence, the order was: subjects/guardians, investigators, clinical research coordinators, sponsors, and other factors.

Throughout the entire process of pediatric drug clinical trials, continuous summary and optimization work should be carried out, and corresponding strategies should be formulated for each responsible entity to effectively reduce the incidence of protocol violations, thereby providing practical reference for improving the quality of pediatric clinical trials.