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Compliance In Focus
Posted by Paul Cobb on Thu, Apr 7, 2016

Enhancing Relationships between Monitors and Research Coordinators

 The relationship between a clinical research monitor and site coordinator can play a major role in ensuringEnhance_Relationship data integrity and compliance with applicable regulations. Positive relationships can foster timely data entry, rapid resolution of queries, and adherence to FDA regulations. On the other hand, strained relationships can delay data entry, prevent resolution of queries and lead to sites being less inclined to follow regulations. The coordinator-monitor relationship is critical to the research process as it serves as a link between sponsors, investigators, and regulatory authorities.

How can we ensure that these relationships are optimized?

Here are 4 ways to improve the relationship between your site’s research coordinator and monitor:

  1. COLLABORATE: Both the research coordinator and the monitor must approach the relationship with a collaborative mindset. It is imperative that both parties work together rather than against each other. The monitor and research coordinator should partner to achieve the mutual goal of ensuring data is accurate and complete, patient safety is upheld, and regulations are followed.
  2. NOT THE POLICE: Both parties must strive to remember that the monitor is not there to punish the sight or the coordinator. On the contrary, the monitor is there to help prepare the site for potential audits and make the site’s hard work look good! This must be kept in mind when conceptualizing the relationship.
  3. RESPECT TIME AND JOBS: Both the research coordinator and monitor should respect each other’s time and job responsibilities.  For the research coordinator, this means providing the monitor with the necessary documents, charts, electronic access, investigational product, time, and resources necessary to complete monitoring duties. For the monitor, this means being cognizant of the fact that the research coordinator has other obligations including outside studies and research subjects. In addition, both parties should arrive punctually for all scheduled monitoring visits and meetings.
  4. ADEQUATE PREPARATION: Closely related to being on time, both parties must be adequately prepared for the monitoring visit. The monitor should be familiar with the protocol, site policies, applicable regulations, and any concerns or issues that are present at the site. The research coordinator should ensure data entry is as complete and clean as possible at the time of the visit, should have addressed previous action items, and should be able to provide the monitor with items requested in preparation for the visit.

   What ideas do you have to enhance the monitor-coordinator relationship? 

Trust Process | IMARC Research

 photo credit: Self Five! via photopin (license)

Topics: Clinical Research, Site Coordinator, Clinical Research Monitor

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