Tips for Better Monitoring Visits

These are four tips for great monitoring visits.  It all comes back to developing solid relationships as a site manager so you will have access, cooperation, and enjoy more productivity during your time on site.

1. Effective Communication Between Visits

Visit
Maybe your coordinators truly are
time-strapped or maybe they just
need a little cheerleading.
 

Great communicators know that strong relationships are built on 2 parts listening/respecting and 1 part actively addressing concerns and providing solutions.   Follow-up with your sites weekly to track enrollment, discuss supplies, answer questions, and track EDC completion.  If things aren’t trending consistently with your other sites work to uncover the root cause.  During your calls remind the staff of important study updates, upcoming data deadlines, or recent correspondence.  This is especially important with complex protocols.  Keep the check-ins positive, praise often, and be respectful of your site’s time.  Communication is a two-way street and hopefully your sites will be comfortable to reach out to you as well.  If you are providing value to your site, they will be more likely to call you when they have questions or concerns rather than proceeding to make errors in execution that you may not discover until your next visit.

2. Assess Site Skill Level
The worst thing you can do is show up to a site and tell them how to run the study.  Don’t discount the experience of the investigator/staff. When you go in like a hall-monitor and immediately criticize their process, they will stop listening, become defensive, and you will not be able to compel them to review or revise. First see and appreciate how they are organized, what source are they using, where are they losing efficiencies, and where could they be more precise.  Your first visit should be more than 75% observation and checking things out and less than 25% training unless they are asking for more.  Remember that you can train after the visit during your follow-up phone contacts.  You will need to tailor your site management approach depending on the experience and comfort level of your site.

3. Prepare for the Visit
From your home office or at least a week in advance of your monitoring visit, read the past report, review that pending action items are resolved, and ensure your study coordinator and other relevant site staff will have adequate time for the visit (if not, consider rescheduling). Know the enrollment rate for this site and other sites in the trial.  Compare the performance of this site with other sites and review all the EDC queries and responses since your last visit.  Communicate the agenda prior to the visit.  If you prepare properly for the visit, you’ll reduce the risk of a non-productive visit and also be ready to handle any surprises you might discover on-site.

4. Demonstrate Flexibility
Sure you have an agenda and you can’t possibly leave the site for the airport until you’ve achieved all of your objectives, but be willing to shift your day around to accommodate your busy coordinator.  You can perform your monitoring tasks in a different order if that helps the coordinator get organized and juggle your visit while still attending to other priorities.  Agree to do drug accountability while your coordinator wraps up a few outstanding queries in a patient chart.  Agree to meet with the PI at mid-day since they have clinic visits all morning.  The staff at the site will appreciate your flexibility.

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About The Author

The Lead CRA

Nadia started The Lead CRA blog in 2007. She is now lead author for ClinOps Toolkit. Nadia is currently working as a Clinical Program Manager at a small specialty pharmaceutical company in the San Francisco Bay Area. You can reach Nadia via email at leadcra@clinopstoolkit.com anytime.