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Tuesday, June 25 • 4:15pm - 5:30pm
#283: Let's Talk Risk-Based Monitoring

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: Let's Talk Risk-Based Monitoring; CME 1.25; IACET 1.25; RN 1.25

Let’s face it, Risk Based Monitoring (RBM) has been in the forefront of our industry for more than 10 years. From the beginning, RBM challenged the belief that 100% source document verification (SDV) would yield quality data in clinical trials. Regulators responsible for making decisions based on reliable data were also challenging industry as to the utility of this monitoring methodology as a way to identify and manage issues in clinical trials. It took some time for the focus of RBM to shift risks in a clinical trial that would include identification and assessment, ongoing monitoring, mitigation as well as even prevention. We are now in an epoch of understanding that it’s about the management of risks in clinical trials that could impact the reliability of patient data, patient safety and patient rights and welfare. In March of 2019, FDA has provided a draft guidance to augment the 2013 guidance relating to risk based-monitoring whereby FDA is making recommendations for planning a monitoring approach, developing content for monitoring plans, and the monitoring of results. Since regulations establish the expectations, it remains up to the sponsor to determine the how in order to achieve the expectation.

RBM has come a long way however sponsors may still struggle with certain aspects in the multi-prong processes needed to be successful with RBM. This forum will present various approaches to RBM, and give the opportunity to learn from experts, so Let’s Talk Risk-Based Monitoring!

Learning Objectives

Describe what is comprehensive RBM , with an understanding of key components to achieve goals of Risk-Based Monitoring in Clinical Trials; Develop a risk-based approach to monitoring of clinical trials that will achieve the expectations for quality clinical data; Identify how to determine best approach based on risks within the clinical trial and consider how to best monitor ongoing risks.


Susan Callery-D'Amico, BSN


A Comparison of SDV to MANA Method: A Risk-Based Monitoring Approach
Penelope K. Manasco, MD, MS

Holistic Approach to Risk-Based Management of Studies and Monitoring of Investigators
Gregg Larson, PhD

avatar for Susan Callery-D'Amico

Susan Callery-D'Amico

Vice President, R&D Quality Assurance, AbbVie, Inc.
Susan Callery D’Amico is a pharma leader with extensive experience in quality assurance and clinical development. She is the VP, R&D Quality Assurance, AbbVie, with the mission to drive quality excellence and continuous improvement as a strategic advantage across the lifecycle of... Read More →
avatar for Penelope Manasco

Penelope Manasco

Chief Executive Officer, MANA RBM
Dr. Manasco has conducted clinical research for over 30 years at the NIH and as an executive at GSK. She has spent 10 years in the area of clinical trial technology. Since starting MANA RBM, her focus has been on enhancing the processes of clinical research to rapidly identify and... Read More →
avatar for Gregg Larson

Gregg Larson

Vice President, Development Operations, AbbVie
Gregg’s career over 25+ years has spanned medical affairs, clinical research, and clinical operations. Gregg assumed his current role as VP, Development Operations in October 2017, which includes Site Management and Monitoring, Clinical Program Development, Strategic Clinical Operations... Read More →

Tuesday June 25, 2019 4:15pm - 5:30pm PDT
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA