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Compliance In Focus
Posted by Paul Cobb on Tue, Apr 15, 2014

The Value of Top Monitors

Monitors that perform their job at a high level can drive the growth and reputation of theirMonitoring Attributes company. The companies that employ these monitors are equipped to meet the needs of their clients and ensure that patient safety and data integrity are maximized.

Top-level monitors possess a unique set of characteristics that allow them to excel:

  • Talent- Highly competent with diverse backgrounds (nursing, engineering, public health, behavioral science, medicine…)
  • Passion- A passion for human subject protection; ensuring that regulations are followed and that data is verified with true source
  • Regulatory Foundation- Rigorously trained on federal regulations and understand how to use this foundation as the basis for site instruction
  • Consistency- Monitoring style is developed early, reinforced through training, and used consistently across sites and studies
  • Strategic- Critical thinking is used to move beyond an “apples to apples” approach and towards a comprehensive evaluation of data verification
  • Risk-Based Monitoring- This is an increasingly used approach; not less monitoring, but more strategic monitoring
  • Extension- Monitors are viewed as an extension of the sponsor team and work hard to serve as the “face” of the sponsor
  • Non-Punitive- A collaborative approach is used to work with sites to become part of the solution and prevent future problems
  • Structure- Monitors are team-based in order to facilitate collaboration, growth and consistency
  • Thought Leaders- Occupy leadership positions in clinical research associations, present at professional meetings and conferences, and use various forms of media to disseminate relevant and insightful information to the industry

Please take time to download our “10 Attriutes of an A+ Clinical Monitoring Service”  infographic.  Are there other attributes that can be added to the list?  Please share your thoughts.

10 Attributes Guide

Topics: Medical Device CRO, Attributes, Clinical Monitoring


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