Vinod Boro
Independent Researcher
Uttar Pradesh, India
Abstract
The evolution of clinical trial oversight has necessitated a shift from traditional on-site monitoring methods to adaptive, risk-based monitoring (RBM) frameworks. This manuscript explores the applicability and advantages of RBM in investigational drug management, focusing on regulatory compliance, data integrity, subject safety, and cost-effectiveness. RBM provides a systematic approach to identifying, assessing, and mitigating risks that may impact investigational product (IP) quality and trial reliability. By integrating real-time analytics, centralized monitoring tools, and predefined Key Risk Indicators (KRIs), RBM frameworks enable early detection of anomalies and efficient resource allocation. The literature supports RBM as a transformative approach, particularly suited for complex multi-center trials. This manuscript reviews key models, regulatory guidance, implementation methodologies, and real-world applications of RBM in drug accountability, storage, dispensing, and documentation processes.
Keywords
Risk-Based Monitoring; Investigational Drug Management; Clinical Trials; Centralized Monitoring; Regulatory Compliance; Drug Accountability; Key Risk Indicators (KRIs); GCP; Trial Oversight.
References
- Food and Drug Administration. (2013). Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring.
- (2016). ICH E6(R2) Guideline for Good Clinical Practice.
- Getz, K. A., & Campo, R. A. (2017). New benchmarks for the adoption of risk-based monitoring. Applied Clinical Trials, 26(2), 18–24.
- Grignolo, A. (2016). Risk-Based Monitoring and ICH E6(R2): Optimizing Clinical Quality. Clinical Researcher, 30(9), 12–18.
- Morrison, B. W., et al. (2014). Risk-based monitoring: Building quality into clinical trials. Therapeutic Innovation & Regulatory Science, 48(5), 447–455.
- Mehta, R., & Kravitz, L. (2015). Integrating risk-based monitoring into global clinical trial management. Journal of Clinical Studies, 7(4), 38–43.
- Thoma, A., & Farley, J. F. (2016). Leveraging centralized monitoring for enhanced data quality. Clinical Trials Insight, 5(2), 44–51.
- TransCelerate Biopharma Inc. (2015). Risk-Based Monitoring Methodology Position Paper.
- Brosteanu, O., et al. (2017). Risk-adapted monitoring is associated with lower trial oversight costs. Contemporary Clinical Trials, 60, 51–57.
- Zarin, D. A., & Tse, T. (2016). Moving toward risk-based monitoring in clinical trials. NEJM, 374(9), 785–787.