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Compliance In Focus
Posted by Stephani Hulec on Wed, Jun 4, 2014

Monitor Turnover – Tips to Minimize Challenges

As we in this industry are aware, turnover from both the sponsor and/or monitoring CRO isMonitor Turnover – Tips to Minimize Challenges extremely high compared to other fields of service.  In order to have a monitor turnover rate lower than the industry standard, companies should recognize the importance of minimizing turnover whenever possible and proactively adapt strategies to do so.  However, in the event when turnover does occur, companies should also strive to make the transition to a new monitor as smooth as possible for both the sponsor and site(s).

Anyone who works as a monitor knows that this is a competitive industry, where sometimes having a  grueling travel schedule, while juggling multiple sponsors and studies, can lead to monitor “burn out”.  When sites are re-assigned due to a monitor leaving the company, taking on other assignments, etc., this can have potentially negative effects on the sponsor’s end, as well as detrimentally affect the clinical sites with whom we work.

There are several typical problems that result due to monitor turnover in our industry.  A few examples are:

  1. It can be frustrating for sites (and in turn sponsors) to not know who to contact for different questions.
  2. Sites may be told different things by various monitors (“Yes, you need to report this deviation to your IRB” or “No, this is not a reportable event”).
  3. Productivity on the study may decrease at the sites, if they become frustrated with their monitors (and in turn that sponsor).
  4. Uninformed monitors may communicate incorrect directions to sites (i.e. requirements for how the site’s regulatory binder should be organized; the process for maintaining informed consent documents; etc.).

Below are several strategies that IMARC employs to ensure that when this challenge occurs and a monitor does leave (or sites are reassigned), the change in monitor presents the least amount of unfavorable effects possible.

  • Implementation of a Regulatory-Based Training Program:
    • Each new IMARC CRA receives the exact same training, regardless of their experience in the field or other prior positions in clinical research (i.e. those with previous monitoring or nursing backgrounds).
    • The rigorous training program is consistent for all employees and is strongly based in the federal regulations that govern clinical studies (21 CFR Parts 11, 50, 54, 56, 812/312; ICH GCP E6; ISO 14155).
  • Internal Collaboration for each Clinical Study:
    • Each study has a team of at least one monitor and one Lead CRA, who have all received training on the protocol (and EDC system, if applicable).
    • The study team, including the Lead CRA and all monitors, have internal meetings in correlation with, or in addition to, the meetings initiated by the sponsor team.  This provides a stage for group discussions of issues noted on-site, thus ensuring that everyone on the IMARC team is on the same page.
  • Management Involvement:
    • Each study team is managed by a Lead CRA.  The Lead CRA oversees the monitor(s) on that particular study, providing the monitors with the same pertinent information from the sponsor, which in turn helps the monitors provide consistent messages to their sites.
    • The Lead CRA also filters questions from the monitor team to the sponsor, which increases productivity at both the sponsor and monitor sides.
    • One essential function of the Lead CRA includes a peer review process of all study documents, such as monitoring reports and follow-up letters, that are sent from IMARC to the sponsors and sites; this standardizes the way issues noted by the IMARC monitor are documented across the study.
    • Because the Lead CRA is also trained on the study, they have the capability to step in and cover for visits where the monitors on the team may otherwise be unavailable.  And, in those situations when turnover occurs, the Lead CRA can assume the schedule until another CRA is brought up to speed.
  • Specialized Monitoring Skills:
    • As monitors continue to gain experience in a variety of therapeutic areas, IMARC may form sub-groups of monitors who have become proficient in a particular field.  While these monitors continue to increase their expertise, they then serve as mentors for newer monitors that may join the study teams.
    • Monitors may become specialized in their experience with a particular sponsor, as IMARC strives to provide consistency between the monitor teams as we work on subsequent studies with that sponsor.

IMARC has received feedback from numerous sites that either have multiple IMARC monitors for several clinical studies, or who have seen monitor staff changes throughout the course of a study, that “all IMARC monitors are the same”.  Although sites are not overly pleased when monitor turnover occurs, providing them with a consistent approach to our monitoring lessens the scope of this minor setback.\

How do you minimize the effects of turnover in this industry?  Do you have any tips to add to this list? 

Photo Credit: SalFalko

Monitoring as a Mindset


 

Topics: Monitor Turnover, How to Minimize, IMARC Research

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