Risk-based monitoring is the process that ensures the quality of clinical trials by identifying, assessing, monitoring and mitigating the risks which affect the quality or safety of a study. 

The word monitoring refers to different meanings in different context. Monitoring in clinical context refers to the assessment of the Clinical Investigator conduct, oversight and report of findings of clinical trials and includes monitoring of private sponsor, contract research organization process, and clinical investigations proposals, design, performance, records, reviews, and reports.

The traditional monitoring process completely relies on source data verification which is time consuming and costly. RBM approach is centralized and reduces the time and cost of data verification.

Monitoring activities include communication with the clinical investigators, study staff, review of the study process, procedures, records and verification of data accuracy submitted to the sponsor.

Clinical trials are critical to the development and delivery of all the medical treatments. Based on the trials, you can evaluate the drugs, devices, and treatments that are safe and effective for humans and identify the therapies which will work best for a particular illness and patient populations. To achieve successful clinical trials, the quality of data, protection of patient safety, speed and affordability is very essential.

Sponsors identify critical data and processes that are inaccurate, not performed, or performed incorrectly. This data remains a threat to the protection of human subjects or the integrity of the study results. RBM breaks the threat and serves as an efficient monitoring tool.

The paper-based data collection is a practice that still occurs in some of the clinical trials, but the medical industry is increasingly shifting towards processes that digitize clinical data.

Digitization impacts the earlier detection of data quality issues and makes possible a string of actions that were not feasible using a paper-based data collection, which is the risk-based monitoring (RBM) approach. To improve the quality of data collection, tracking data real-time and improve the analytic capabilities, RBM serves as the entry and provides storage of digital data.

1. Understand and perform cross-study analysis of quality, risk, and monitoring
2. Make data-driven decisions around site monitoring activities
3. Learn to use methods for improving patient safety and data quality
4. Identify critical data and processes
5. Perform risk assessment
6. Develop a monitoring plan

1. Pharmaceutical or Biotech Executive
2. Pharmaceutical or Biotech Director
3. Pharmaceutical or Biotech Senior Manager
4. Quality Assurance (QA) Specialists
5. Clinical Research Specialists
6. Clinical Research Associates (CRAs)
7. Clinical Investigators
8. Regulatory Affairs Professionals

Professionals with basic exposure to any of the fields like Clinical Operations, Study Monitoring, Clinical Research, Data Management, Regulatory Affairs, Clinical Compliance, Clinical Quality, Quality Assurance and Study Management