Drug Information Association Logo
« Back to Listing

Risk-Based Monitoring: Where We Are and Where We Are Headed

Track:
Processes and Technologies for Clinical Research

Day & Time:
June 19, 10:45AM - 12:15PM (Pacific Standard Time)

Session Number:
418

Room Number:
10

Level:
Advanced

Type:
Symposium

Title:
Risk-Based Monitoring: Where We Are and Where We Are Headed

Chair(s):
Amita Malik, MS
Senior Product Strategist
Oracle Health Sciences, United States

Description:
The recent FDA guidance on risk-based monitoring (RBM) creates an opportunity for sponsors to leverage the advantages of reducing the amount of source document verification. This symposium will examine the current state of RBM, including how to implement a risk-based monitoring strategy, dealing with the challenges of RBM and how to overcome these challenges. In addition, speakers will provide practical guidelines for developing and deploying an effective RBM strategy.

Learning Objective(s):
Define the critical steps to develop and implement guidelines for a successful risk-based monitoring (RBM) strategy; Discuss the challenges in implementing an RBM plan (from both a sponsor and site perspective); Identify methods to overcome the challenges encountered when deploying an RBM strategy; Determine ways to effectively utilize technology as part of an RBM strategy.

Presentation(s) & Speaker(s):
Risk-Based Monitoring: Overview of the Current State and Guidelines on How to Design and Execute a Risk-Based Monitoring Plan
Amita Malik, MS
Senior Product Strategist
Oracle Health Sciences, United States

Addressing Key Aspects of the EMA Reflection Paper on Risk-Based Quality Monitoring: Quality Tolerance Limits and Quality Report
Andrew Lawton
Global Head, Clinical Data Management
Boehringer Ingelheim Ltd., United Kingdom

Experience Conducting Studies with Risk-Based Monitoring Strategies
Nycole Olivo, BSN, MA, RN
Senior Manager Clinical Operations
ICON, United States