10 attributes of an A+ clinical monitoring service
Monitors that perform their job at a high level can drive the growth and reputation of their 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 collab...
Source: Mass Device - Category: Medical Devices Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news
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