Dinner Short Course*
Monday, May 13, 2019 | 6 - 9pm
SC1: Central Monitoring Deconstructed from Raw Data to Monitoring Actions: An In-Depth Walk Through - Detailed Agenda
Nechama Katan, Associate Director, Central Monitoring Lead, Risk Based Monitoring, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development, Pfizer
Renuka Kelapure, Pfizer
Jennifer Campbell, Associate Data Analyst, CluePoints
Many organizations are still struggling to define central monitoring and the skills necessary for successful implementation. During this hands-on, dinner workshop we will discuss critical skills necessary for RBM implementation and walk through how to
evaluate a RBM finding, write a signal/issue for the study team, and how a team reviews the finding before taking action.
Key Learning Objectives:
- How is Central Monitoring different that Traditional Monitoring?
- What skills are needed to be successful in Central Monitoring?
- Why critical reasoning skills are crucial to RBM implementation.
- How KRIs and Statistical Data Analysis complement each other in RBM.
- How to evaluate an RBM “result” and understand if it is an issue.
- How to write a “Signal/Issue” for the study team.
- How a cross functional study team reviews the whole Center before taking actions.
*Separate registration required.