Monitor, Data Manager, and Project Management Training
We offer RBM team training for an entire organization to use on a specific, single trial or functional RBM team training to learn and implement RBM principles applicable in all trials.
The new International Conference of Harmonization Good Clinical Practice Guidelines, effective July 2017, require study teams to move beyond the simple task of checking data to see whether it matches. The new requirements emphasize the importance of understanding data errors, and applying and analyzing the data to better support trial quality.
Many monitors, data managers, and project managers have only used SDV as a method of quality oversight. Current recommendations from regulators have indicated this is inadequate oversight. In addition, our experience is that when you remove SDV as a monitoring activity, monitors are unsure of how to perform quality oversight.
MANA RBM’s proprietary training program incorporates Bloom’s Taxonomy of Learning. See Figure 1 below. This program was designed to help monitors, data managers, and project managers develop or enhance their RBM skills to analyze and evaluate data, not simply mark it as reviewed.
We provide general and study-specific training to organizations and study team. For more information, contact email@example.com