9/01/2020

Sponsored by: Metrics Champion Consortium (MCC), a division of WCG

When: September 8-10, 2020

Where: Virtual

Register: HERE

Topics:

Understanding Risk Assessment and Management
Considering Risk During and After a Global Pandemic
Key Risk Indicators and Quality Tolerance Limits in Centralized Monitoring
Structure and Management of Remote and Onsite Monitoring
Managing Risk-Based Audits
Selecting CRO Oversight Metrics and Vendor Management Systems
Maintaining Effective Sponsor and Vendor Relationships
Assessing Partnership Quality
Determining Foundational IT Systems Best Practices
Bridging the Gaps Between CAPA and RBQM

Sandra “SAM” Sather, VP of Clinical Pathways and a 2020 MCC Ambassador, is speaking on the topic “The RBM Training Gap: Risk-Based Monitoring the Noun vs. the Verb”. Have you heard "We are not doing RBM for this study . . ." What? Our quality system should support a risk-based approach to many clinical trial activities like site monitoring, data quality oversight, vendor oversight, safety surveillance, audit planning, and more. Sure you train on what risk management is and also what your process is for risk assessment, but what do the team members that work directly with sites or project teams not understand is that we don't have RBM trials and non-RBM trials. This is holding us back from critical thinking during project management, vendor oversight, and site monitoring. Many times, the use of RBM at study start-up as a noun in the vendor selection creates a false understanding that we are not doing risk-based thinking for all trials. There is a large gap in the "elevator speech" from senior management, vendor selection defense teams, audit representatives describing how risk management is ensured at the project level.

Attend SAM’s session to learn how to:

Identify the gaps in RBM training,
Recognize the misuse of the term RBM and impact during study set-up of SOW and monitoring plan development,
Describe some ways to assess and address gaps

The virtual summit consists of pre-recorded sessions and community discussion groups. For the most effective session, view the pre-recorded session before the live discussion. SAM’s live virtual community discussion group is on September 10th at 10:15 a.m. EDT.

Sandra "SAM" Sather’s current focus of consulting is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions. She has over 35 years of clinical experience, has a Bachelor of Science degree in Nursing and a Master of Science degree in Education with a Specialization in Training and Performance Improvement. SAM has been dual certified by the Association for Clinical Research Professionals (ACRP) for over 15 years as a CCRA and CCRC. She is a current ACRP Fellow, which is awarded to individuals who have made substantial contributions to the Association and the industry at large. She is a frequent speaker at industry conferences and has authored dozens of courses for clinical research training programs in various functional areas. She has multiple training, monitoring and project management experiences of diverse size, and objectives with a variety of global clients. In 2002 she co-founded Clinical Pathways (CP), LLC with Charles "Chuck" Sather.

- The Clinical Pathways Team

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