References
Further Reading:
1.“Data and Safety Monitoring Plans and Boards.” Human Research Protection Program (HRPP), 13 July. 2026, https://irb.ucsf.edu/data-and-safety-monitoring-plans-and-boards#:~:text=All%20Phase%20III%20studies%20require,the%20protection%20of%20the%20subjects.
2.Practical applications of regulatory requirements for signal detection and communications in pharmacovigilance - Scientific Figure on ResearchGate. Available from: https://www.researchgate.net/figure/Determination-chart-for-Data-Safety-Monitoring-Board-DSMB-requirement-Clinical_fig2_340650566 [accessed 10 Oct 2024]
3.Evans SR. Independent Oversight of Clinical Trials through Data and Safety Monitoring Boards. NEJM Evid. 2022;1(1):EVIDctw2100005. doi:10.1056/EVIDctw2100005
4.Data Safety and Monitoring Board. https://toolkit.ncats.nih.gov/module/clinical-trials-and-fda-review/serving-on-boards-to-review-and-monitor-clinical-trials/data-safety-and-monitoring-board/
5.Sandercock PAG, Darbyshire J, DeMets D, et al. Experiences of the Data Monitoring Committee for the RECOVERY trial, a large-scale adaptive platform randomised trial of treatments for patients hospitalised with COVID-19. Trials. 2022;23(1):881. Published 2022 Oct 18. doi:10.1186/s13063-022-06824-6