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

Instructors:
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.



TO SUBMIT TOPIC IDEAS OR SPEAKER REFERRALS, CONTACT

Lee Yuan
(+1) 781-972-5404
lyuan@healthtech.com

TO SPONSOR & EXHIBIT, CONTACT:

(Companies A-O)
Ilana Quigley

(+1) 781-972-5457
iquigley@healthtech.com

(Companies P-Z)
Patty Rose
(+1) 781-972-1349 
prose@healthtech.com

TO BE A MEDIA PARTNER, CONTACT:

James Prudhomme
(+1) 781-972-5486
jprudhomme@healthtech.com