Risk is Everyone’s Business: A Cross-Functional Approach to RB-CDM
Information
Session chaired by Sas Maheswaran
Description:
Risk-based clinical data management (RB-CDM) has enormous potential to transform how data is reviewed and managed by effectively deploying resources to focus on the most critical issues, ultimately improving quality and accelerating timelines.
However, RB-CDM efforts will not find success if they start in isolation or ignore the lessons learned from over a decade of risk based initiatives - most notably, risk-based monitoring (RBM).
Risk management needs to start early, should be ongoing through the study lifecycle, and should be adaptable and managed centrally. All departments should be aligned on the same goals and incorporate tasks required of their departments.
RB-CDM approaches require the right people, preparation, processes, and technologies to support the cross functional collaboration necessary for long-term success.
How can Clinical Data Management (CDM) play a role in promoting RB-CDM not only within their departments, but also cross-functionally? This session shares experiences from identifying process improvement opportunities to enacting quality by design and risk management in practice, and how the lessons from those can be incorporated into future RB-CDM initiatives.
