Risk Based Monitoring Training

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 principles of centralized analytics used in other industries currently carry multiple benefits like improved quality of operations and lower cost products. Using risk-based monitoring (RBM), these principles get applied to the pharmaceutical development and clinical trial monitoring.

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.

Risk-Based Monitoring goals can be achieved using Digitization which controls and ensures that clinical data is accurate, complete and verified. The other most important achievement of RBM using digitization is an enhancement of safety of patients in the clinical trial and ensures the rights and wellbeing of human subjects protection.