Risk-Based Monitoring Approach to Ensure the Quality of Clinical Study Data and Enable Effective Monitoring.
Ayano HigaMichie YagiKenta HayashiMasanori KosakoHiraku AkihoPublished in: Therapeutic innovation & regulatory science (2020)
The results indicate that a risk-based approach, which is an innovative monitoring approach, contributes to the reliability of study results and promotes efficient monitoring.