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.
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| 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.
Reader questions may have been edited for spelling or grammar, for reasons of anonymity, truncated, or edited in other ways although the main content remains unchanged.
You may also like...from The Lead CRA archives:
- Selecting Qualified Investigators April 2010
- Pre-Study Visits January 2008
6 comments:
I like the fake party idea!
Scheduling is a good idea. Make a brief organized presentation. Try not to let them intimidate you. You have a job to do so act confident. Gently remind them that is part of what they agreed to do. If you have serious concerns they need to be elevated.
I like to let the PI know that I will document in the report whether or not the issues were discussed with the PI in person during visit along with any issues related to scheduling meetings with the PI to discuss the progress of the study and the safety of the subjects.
one of the interviewer ask questions
1)what will you do if the coordinator is not in the site?
2)what will you do if some documents missing in the regulatory file in Prestudy visit ,site initiation visit,& ongoing site monitoring visit?
3)what is the excited thing in CRA PROFESSION?
4)what is the most difficult thing in CRA PROFESSION?
5)what is the LEAST THING CRA can do?
It's critical to set expectations for meeting with the PI early in the study (i.e., at the site qualification and/or site initiation visits). Also, I find that if I always bring something of interest to the PI meetings, they are more likely to make time for me. I keep notes for each study of critical timelines, recent FAQs, enrollment status, etc. so I always have something valuable to discuss.
Hi Nadia-
Great post about 'nudging' reluctant P.I.'s! If I may, I'd also like to add a little something.
Some sponsors/CRO's are really strict about CRAs meeting with their investigators at every monitoring visit. Some employers even record missed 'meetings' (e.g. the number of visits without PI meeting, number of days in-between PI meetings, etc.) as one of several metrics assessed at your annual review period.
As such, one's very performance review (and, hence, one's salary!) may, in fact, depend on being able to make contact with the P.I. on a regular basis.
However, there are many steps you can take to protect yourself, in order of increasing urgency:
1. Use your confirmation letters to schedule 10-15 minutes of the monitoring visit.
2. At the first missed meeting (i.e. one visit without a face-to-face with the PI), document this in your follow up letter and remind the Coordinator that you are available by phone to speak with the PI.
3. If you still haven't met in person or spoken by phone with the P.I. by the end of the second monitoring visit, state so in your follow up letter, keep your Lead CRA/Project Manager in the loop about your attempts, and, if appropriate, try contacting the budget/finance person at the site (if there is one) to remind them that one of the site's contractual obligations (i.e. steps they need to take to get paid), is for the P.I. to maintain regular contact with the Sponsor and/or its designees (i.e. YOU!).
4. As a last resort (and with your PM's permission), get the Sponsor DIRECTLY involved, and be ready to provide evidence of your attempts to contact the PI.
You should, as much as humanly possible, avoid any more than two consecutive monitoring visits without a face-to-face meeting with the PI, but if you can at least document a successful (and detailed) teleconference between you, at least the site (and you) can demonstrate a good faith effort to properly keep eachother informed of all important study conduct issues.
Good Luck out there!!
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