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Evaluation of Data Errors and Monitoring Activities in a Trial in Japan Using a Risk-Based Approach Including Central
Hidenobu Kondo1,2, Tomoaki Kamiyoshihara3, Kenji Fujisawa4
1Clinical Operation Steering Department, A2 Healthcare Corporation, Tokyo, Japan. kondo-h@a2healthcare.com.
Therapeutic Innovation & Regulatory Science
|April 20, 2021
Summary
Risk-based monitoring (RBM) reduces on-site monitoring time by 30% and data corrections. This approach, using site risk assessment and central monitoring, ensures subject safety and data quality without significant technology investment.
Area of Science:
- Clinical research methodology
- Drug development and regulation
Background:
- Risk-based monitoring (RBM) adoption is hindered by perceived high technology costs, suitability for only large trials, and data error concerns.
- Sponsors exhibit hesitancy towards RBM due to investment fears and data integrity worries.
Purpose of the Study:
- To evaluate the effectiveness of a risk-based monitoring strategy in a clinical trial setting.
- To compare data quality and monitoring time between partial and full source data verification/review (SDV/SDR) approaches.
Main Methods:
- Implemented a risk-based monitoring strategy involving site risk assessment and central monitoring.
- Compared data errors and on-site monitoring duration between sites using partial SDV/SDR and those using 100% SDV/SDR.
- Clinical research associates (CRAs) assessed site-specific risks.
Main Results:
- Partial switching sites demonstrated no critical data corrections and fewer on-site monitoring corrections compared to 100% SDV/SDR sites.
- The implemented RBM strategy resulted in a 30% reduction in on-site monitoring time.
- Subject safety and data quality were maintained.
Conclusions:
- Risk-based monitoring is feasible and effective, even without substantial technology investment, by utilizing site risk assessment and central monitoring.
- RBM offers comparable subject safety and data quality to traditional methods while achieving cost savings.
- The study supports the broader adoption of RBM strategies in clinical trials.
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