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Compliance In Focus
Posted by Melissa Wollerman on Mon, Jun 25, 2018

New Clinical Study Personnel - How to Manage the Changes at Your Site

As many of us monitors are aware, there is high turnover in the research industry and clinicalHow to Manage the Changes at Your Site sites aren’t exempt from this. Quite often, we are likely to receive an e-mail with very little information regarding the current study coordinator or other study personnel leaving a clinical site. We may possibly receive a sentence that consists of who will be taking their place, or perhaps no notification at all.

How do you go about handling the notification, or lack of notification?

  1. Stay calm. If a monitor has received many of these e-mails before, they know that this can be frustrating; having to train yet another coordinator or investigator that may not be with the site for very long. It’s important to keep your composure and respond to that e-mail expressing gratitude for the notification and for their time and efforts on the study.
  2. Keep in contact. A great way to avoid silence from the site is to often keep in contact with them. A consistent relationship can go a long way, and simply having a personable attitude will make the transition a lot smoother.
  3. Understand the site. Perhaps the site is one that rotates fellows every 6-7 months or has an intern that may only be on the study for the summer. Get to know the site at the first visit so that you can be prepared for these changes.
  4. Inform applicable personnel. The notification from the site may have only been sent to the monitor and no other team members. It’s important to also ensure that all appropriate study team personnel are aware of the change. A simple e-mail to the Sponsor and other members of the study team will ensure that everyone is notified and up-to-date with the personnel changes and can fast-track the training process.
  5. Properly train the new study member. It can be frustrating for the new study personnel who may be walking into a study that is unorganized with little hand-off training by the previous personnel at the site. Also, being brand new to the study and not knowing the process and expectations can be challenging. Ensure that enough time is devoted to training the new member so that they feel comfortable with the study, possibly resulting in a stronger relationship with the monitor.

When you receive that e-mail from the site notifying you that there will be a change in contact, glance over the points above and think about how you can efficiently conduct the onboarding process to ensure you are prepared for this change and future changes.

Have you experienced high turnover at your sites? How did you proceed with the information you were given regarding the new study personnel? How can you make this process better and more efficient?

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Topics: Clinical Sites, Clinical Training, Clinical Study Personnel


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