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Wednesday, June 27 • 8:00am - 9:15am
#305: Building a Roadmap to the Implementation of the Risk-Based Monitoring Process: Facilitating the Perspectives of All Stakeholders

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Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-626-L04-P; CME 1.25; IACET 1.25; RN 1.25

This workshop will allow attendees to look at terms defined by regulatory authorities and to compare and contrast the understanding of risk-based monitoring (RBM) from the perspectives of the various stakeholders. We will use practical examples.

The DIA CDM and RBM Communities have been working on a project that creates a concrete ‘Roadmap’ for companies on how to implement ‘RBM’ - or more generally how to implement a data backbone in the organization that would allow the different functions (data management, pharmacovigilance, medical monitoring, operations, regulatory, etc.) to leverage the appropriate data collected/generated by CDM and other functions as indicators to identify critical risks in their specific area.

Learning Objectives

Define risk-based monitoring (RBM) from different stakeholders’ perspectives: data management, pharmacovigilance, medical monitoring, operations, and regulatory; Compare and contrast terms used in RBM from different stakeholders’ perspectives; Review the major difficulties encountered in each phase of developing an RBM program.


Mary Banach


Where We Are: Where We Are Going
Stephen Young, MSc

Vendor Selection for Risk-Based Monitoring
Nimita Limaye, PhD

avatar for Mary Banach

Mary Banach

Project Manager CTSpedia, Vanderbilt University
Following a career in industry and academic clinical trials, Mary Banach currently leads two programs assisting in developing our understanding of risk in the clinical design process. The first program is a sub-group of the DIA Clinical Data Management group, called the DIA RBM Group... Read More →
avatar for Nimita Limaye

Nimita Limaye

Chief Executive Officer, Nymro Clinical Consultancy Services
She has worked across pharma/CROs for 20+ years, leading global RBM & CDM business. The past chair of SCDM, and on the steering committee of DIA India, Nimita has chaired 2 DIA RBM conferences & has presented on RBM in multiple forums. She provides consulting expertise and services... Read More →
avatar for Stephen Young

Stephen Young

Chief Scientific Officer, CluePoints
As Chief Scientific Officer for CluePoints, Steve oversees the research and development of advanced methods for data analytics, data surveillance and risk management, along with providing guidance to customers in RBQM methodology and best practices. Steve worked for three bio-pharmaceutical... Read More →

Wednesday June 27, 2018 8:00am - 9:15am EDT
Room 254AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Data Standards, Workshop