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Sunday, March 4, 2012

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

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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6 comments:

Anonymous said...

Loved the quick tips. I also loved your use of the cheerleader trophies. Very clever. Being prepared for the visit is the best tip and you are right. CSCs do not like to be micromanaged. Offer your help and guidance if they ask you but your focus is the SDV and your agenda. You need to be flexible and respectful of the site's time. Great advice. Thanks for sharing.

Nirav Parekh said...

Dear Nadia, I want to thank you for writing this type of blog because its a really very useful and important information for the entry level CRA like us. I love to read Investigator selection, monitoring, site selection, SMF and travelling with you BOSS !! wowwhhhh ! Its very interesting! have a feeling like on JOB ! I use to refer this blogs for preparing some of my presentation too.
Thank you for sharing your experience with us.

NadiaBoBadia said...

I just love comments like yours - I am inspired to post more. Have a great week and please email me at leadcra-mail@yahoo.com if you think of additional content that you would like to see.

Nirav Parekh said...

I will defiantly contact you if I need any additional content and thank you for your consideration.
Nirav Parekh

Anonymous said...

Hello Nadia,

I am thinking about taking on a CRA role. i am curious as to the job content. Can you please walk me through the Process from when A CRA gets assigned a protocol to initiating a site. How involved are the supervisors, who schedules the visits. who assigns the protocols. Your expert response will be graetly appreciated

Peter said...

Hi Nadia,

In interview for CRA they often ask the following questions:

1. Describe an event or events you handled successful and you are proud of
2. Situation when you disagreed and how did you handled.

Please suggest some of tactful answers.

Thank you,

Pravin

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