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Thursday, August 11, 2011

Lead CRA Q&A: Meeting with a Principal Investigator

Anonymous commented in... "Routine Monitoring Visits":
Could you please give advice about how to deal with the "difficult" Principal Investigator who doesn't want to meet you despite the numerous efforts to persuade him? Any recommendation would be very appreciated! -May 26, 2011 2:54 PM

NadiaBoBadia responds...
Thank you for a great question.  I've partially addressed it before in a post from the archives called "Who's Running this Study?"  Even though Principal Investigators (PI) have made a commitment to personally oversee the safety and conduct of the trial (In the US, see FAQ for FDA Form 1572) they often can't find time to actually meet with the monitors during our visits.  This happens quite often so I definitely want to address your question.  Remember, that there is no regulatory mandate that we talk to the PI but certainly it is a best practice.  However, I don't want to understate the importance of regularly briefing with the PI.  Remember from my post on Routine Monitoring Visits that the PI discussion is an opportunity to address important topics that affect conduct, can positively impact data reliability and validity, and ensure vigilance in reviewing ongoing subject safety.  If your trial is still recruiting, meeting with the PI can be instrumental in influencing study enrollment (related post).

My interest when I am monitoring is to meet all of my objectives as efficiently as possible and leave the site as soon as I have met my goals.  Guess what though, doctors are busy.  In turn, I offer my PIs flexibility where I can.  I do not insist that they drop everything and meet with me each visit.  Generally, I have more success when I schedule an appointment time (say 15-30 minutes) in my confirmation letter and confirm it a few days before arriving.  If the PI truly can't meet though, a telephone contact within 10 days of the visit will be an effective alternative for communicating important findings during the visit, pending items for resolution, or general study updates or training.  I document the call in my report, in a separate telephone contact report for the TMF, and/or an email recap.

Trick your PI into a meeting! Tell the
doctor there is a party they must attend and then tackle
them with your visit findings - just kidding!

Part of our goals as monitors are to prepare PIs for audits and also to influence operations of a trial.  We help bring corrective action for any missed procedures and help them document anything that may need to support the record of conduct down the road.  We help them defend their data and demonstrate that patient safety is protected.  The PI meeting furthers these goals so it is important to budget time for it.  Don't use the meeting just to criticize the "difficult" PI and the study site staff.  Give them kudos and tell them what is going well and also where improvements may be needed.

If you pitch the PI meeting like this, act accordingly, and are respectful of the PI's time then the meetings are more productive and more likely to occur.  As you build a relationship with your PIs, they will see that you are committed to helping them conduct the trial properly.  As your PIs grow to trust you as a partner to their site, they are more likely to make time to meet with you.

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