[Edaily Kim Hyung-il Reporter] Contract Research Organization (CRO) C&R Research(359090)announced on the 25th that it will share case studies on risk-based data management in response to changes in global clinical trial regulations.
(Photo courtesy of C&R Research)
To this end, C&R Research will host its 8th webinar on the 16th of next month under the theme “RBQM: Now a Necessity—How Did We Tackle Clinical Data Management? Query-Based Risk Signal Detection and RBDM Application Cases.”
This webinar was organized to introduce methods for applying risk-based quality management (RBQM) in actual clinical trial settings, as the importance of RBQM has grown following the revision of ICH E6(R3), the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline on clinical trial management.
C&R Research has established a risk-based data management system that utilizes queries arising during the data management phase not merely as a means to correct data errors, but as signals indicating potential risks. For example, if the same type of data error or inquiry occurs repeatedly in a specific clinical trial, the approach involves not merely treating it as an isolated error, but analyzing the occurrence patterns and trends to identify potential risk factors. Through this process, the Data Management (DM) and Clinical Operations (CO) departments share risk information, leading to improvements in data quality.
The webinar will consist of two sessions. Koo Myung-yeon, Team Leader of the DM1 Team at C&R Research, will present “RBQM Overview and Framework,” explaining the concept of RBQM and its application in accordance with the ICH E6 (R3) revision.
Following this, Kang So-young, Team Leader of the DM3 Team, will present “DM Perspective: Practical Applications,” introducing case studies of RBDM implementation. The session will cover practical aspects such as how to classify risk levels during the data review process and how to analyze trends in queries arising from data review results (Risk Trends).
An official from C&R Research stated, “By reinterpreting query patterns and trends from a risk perspective, we can proactively identify potential risks and improve data quality,” adding, “Expanding this perspective is the first step toward successfully establishing RBDM.”
Meanwhile, registration for this webinar is free via the C&R Research official website, and pre-registration is open until the 11th of next month.
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