NAMSA White Paper: Risk-Based Monitoring: A Cognizant Approach

In Clinical, FDA by Katie Schaaf

Conducting clinical trials in today’s environment of evidence-based data requirements combined with reduced funding and budget constraints is forcing sponsors and CROs to take a more measured approach to implementing their studies.

This, in combination with FDA’s guidance document on risk-based monitoring and the European Medication Agency (EMA) reflection paper on risk-based quality management in clinical trials has accelerated a movement to approach one of the most expensive budget line items (monitoring) in creative ways. The most effective means to implementing risk-based monitoring requires a cognizant and thorough approach from the beginning of the trial; continually assessing data integrity and patient safety at the study and site level by leveraging not only technology and tools, but intellect and resources from all members of the clinical study team.

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Authors:

Katie Schaaf is the Director of Strategic Partnerships at NAMSA. Katie has oversight of NAMSA’s Training and Education programs and oversees the operations and manages the relationships for NAMSA’s clients that have long-term clinical and consulting needs across multiple projects with NAMSA. In her 15+ years in the medical device industry, Katie has supported and managed all phases of clinical research, including many IDE feasibility, pivotal and post-approval studies. Katie has developed, organized, administered and conducted training sessions and seminars on several topics, including Clinical 101 (full day and half day) both externally and internally to non-clinical colleagues and has been a guest lecturer at St. Cloud State University (Masters in Clinical Research program) and St. Catherine’s University (Doctorate of Nursing program). She holds a M.S degree in biostatistics from the University of Minnesota and a B.S. in mathematics from the University of Wisconsin – River Falls.