Coordinators Should Strive to Complete Monitor To-Do Lists During Site Visits
Site coordinators should set aside time to meet with monitors during site visits and complete as many action items on the monitor’s to-do list as possible during or shortly after the visit. That’s the advice from a monitor who has been on both sides of the fence.
Kristen Bauer, senior regional clinical research associate with BIOTRONIK, has 16 years of experience in the clinical research industry, with six years each as a site coordinator and monitor. “When I was first starting out as a coordinator … a lot of times I didn’t have all day to spend with my monitor, so I would take the list and be like, ‘great, I’ll work on this later,’” said Bauer. “But you know that never happens.”
A monitor’s to-do list can have action items such as errors or missing data that were noted during the visit and need to be fixed, as well as queries coordinators may need to address. Bauer said coordinators frequently put off the to-do list until right before the monitor returns, which may take up to six months. By that time, the information is no longer fresh in the coordinator’s mind, making it much harder to complete the list.
According to Bauer, coordinators should set aside time to meet with the monitor during their visits and schedule time for the principal investigator to meet with the monitor as well. The coordinator should be present at that meeting, she said.
Among the mistakes Bauer commonly sees coordinators make are failing to understand the difference between clinical visits and study visits, failing to follow the protocol, and not understanding their role and the roles of others at the institution, such as the principal investigator. Other issues that trip up coordinators include not sufficiently educating themselves about clinical trials and failing to record all pertinent data.
Contrary to what some coordinators think, monitors are not the enemy, Bauer told CTA. But she acknowledged that not all monitors are created equal.
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