Risk-based Monitoring (RBM) of clinical trials is an approach that combines on-site monitoring along with centralized remote monitoring by coordinating centers. Based on risk assessments about how the clinical information is captured and protocol designed, risk-based monitoring activities can be proactively supported by the usage of reporting tools.
CROS NT discusses the considerations and impact of centralized statistical monitoring and which technology solutions will facilitate this approach. Centralized Statistical Monitoring (CSM) is the remote evaluation and analysis carried out by clinical trial personnel (e.g. clinical monitors, data managers, statisticians, etc) at a location other than on-site. This approach focuses on targeted data cleaning, subject level data review and statistical analysis to decide whether an on-site visit is triggered by risk.
Why Centralized Statistical Monitoring (CSM)?
Centralized monitoring has been proposed as a new, more efficient approach to on-site visits. A CSM approach can be useful in detecting faulty equipment errors, negligence or fraud, protocol deviations and unexpected patterns which then identifies the sites that need further investigation.
Centralized monitoring techniques can be applied to:
- The monitoring of data quality through routine review of submitted data to identify different types of errors
- The identification of data trends not easily detected on-site like data consistency and accuracy or missing data
- The analysis of site characteristics which aids in defining poorly performing sites
- The verification of critical source data remotely
- The completion of administrative/regulatory tasks
CSM has been suggested as a cheaper and more efficient alternative to on-site monitoring. Source Data Validation is usually time consuming and not as effective at identifying potential risks. A CSM approach performs data quality checks on all trial centers at the subject and site level. Statisticians can then analyze the data in real time to identify sites that need further investigation due to unusual data patterns.
The main errors found at the participant level are incorrect dates and outlying values. Meanwhile, at the site level, data discrepancies can be found when rounding numbers, comparing mean/average results, analysis of variability, inliers and correlation checks. In a CSM strategy, many of these discrepancies can be improved using technology solutions.
Electronic Data Capture is an essential part of an RBM technology strategy since it captures data in real time. EDC allows Investigators to capture and monitor site activity and captures data and determines which data need to be verified and analyzed. Although most EDC systems provide built-in reports to support data management activities, other metrics and information which are needed to verify the risk-based approach are not provided to final uesrs.
Therefore, analytical business intelligence tools should be considered. By using a business intelligence tool to query the EDC database, reports can be designed depending on the target audience involved in the trial review including project and data managers, site staff, clinical monitors and safety staff. Reports with centralized monitoring metrics that assess site activity can be easily made available for quick analysis and decision-making.
Clinical data visualization and analysis are especially important to aggregate data across multiple systems and even multiple studies. An added value is the ability to drill-down data and click-through multiple levels of detail. Tools available today are generally cloud-based which means Sponsors avoid the technology hassle of HTML or plug-ins and enjoy the convenience of data “on the go”.