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Medical Device CRO Blog

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Monitoring: A Risked-Based Approach Day-to-Day

  
  
  

Oftentimes when one thinks of clinical trial monitoring, he thinks of a monitor making periodic site visits to the hospital or institution where the trial is taking place.  During these visits, the monitor verifies the data collected with the site’s source data and study documentation, among other duties.  These periodic site visits are often scheduled and made on an elapsed duration.  For example, some sponsors/studies require a monitor to be on site every 4-6 weeks to keep tabs on the data.  Seems like a pretty straightforward, streamlined, routine process, right?

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