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Compliance In Focus
Posted by Brandy Chittester on Thu, Jan 3, 2013

Your Site. Our Eyes.

We call it providing a "Third Set of Eyes."  Interestingly enough, most IMARC monitors have aYour Site. Our Eyes. background in nursing, or as research coordinators. It may very well be that this experience has assisted us in monitoring to empathize with each subject. After all, so many years were spent one-on-one with patients; we see them as individuals- not just subject numbers.

Working for an independent monitoring company allows us to be unbiased. We have no stake in the outcome of the studies. We are concerned with the patients that may receive this investigational product not only during the study, but also once it is released to the public. Diligent review for non-compliance helps ensure the integrity of the data and does not skew the outcome of the study.

In fact, one of the fundamental principals of monitoring is patient protection. For instance, thorough review of the informed consent document ensures that all of the risks are identified and all of the required regulatory language is there to ensure the subject is informed and protected.  But what about going beyond the informed consent?

In the field, our monitors have experienced this first hand. Below are a few instances where putting the patient in the forefront of your mind can really make the difference.

  • One monitor finding at a site was that the subject underwent unnecessary imaging because the site was not familiar with the complex protocol requirements.
  • In another example, a patient was randomized to the control group but accidentally given the investigational product. The monitor caught the error during a monitoring visit.
  • In one study, patients were accidentally scheduled for 2 CT scans and went to both! This was identified by a monitor during a monitoring visit.

Rather than simply reporting this deviation, the monitors also encouraged the sites to work with their IRBs to ensure they understand what their patients are going through.  One of our monitors was recently told by a research coordinator that she could tell the monitor had the patient in mind while reviewing data in the way she approached corrections with the coordinator.

Working with patients in the past has really enabled us as monitors to be an efficient and caring set of third eyes. Do you have any similar experiences? Feel free to share!

Photo Credit: bigoteetoe

Topics: Informed Consent, Non-Compliance, IMARC Research, Clinical Monitoring


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