ACRP Interviewed SAM Sather on Effective Quality Risk Management

7/28/2020

The Association of Clinical Research Professionals (ACRP) interviewed Sandra “SAM” Sather on “Effective Quality Risk Management as a Mindset” July 8th. An ACRP Fellow, SAM shared her expertise on why the industry frequently misunderstands what is meant by risk-based monitoring (RBM) and quality systems. There is a misconception that clinical trials will either be done with RMB or traditional 100% SDV monitoring, when all trials need to have the approach of being based on risk. Quality risk management is appropriate for all trials regardless of the monitoring plan and is required based on ICH E6(R2). The decision is not whether RBM will be done, but rather how the trial will be done based on RBM. Visit the ACRP site to view the interview in its entirety by clicking HERE.

You may also be interested in our blog about SAM’s article in Clinical Leader, “Remote Monitoring In The Wake Of COVID-19 — Practical & Regulatory Considerations.” Click HERE to read more.

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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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