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.


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

5 Career Tips for a Young CRA

I came across a fun little article on biospace that offers career advice: 5 ways to be a rockstar at work (via Biospace).  

This post echoes the format of that article and I hope you will find it interesting and leave me a comment or email some feedback. 

Although I have transitioned to in-house, the bulk of my experience as a CRA is in Regional Monitoring.  Reflecting back on the career tenants I stand by, I am sharing today my 5 best career tips for a new travelling monitor.

1. Be a Partner

• An auditing approach to monitoring will strain your relationship with the site staff.  You know the regulations that govern our work and you understand the study that you are monitoring including all the expected procedures, assessment windows, and special instructions provided in newsletters and in other study correspondence.  Your attitude can be to train the study site personnel and share with them this information to help them protect subject safety and data integrity, or you can go in and point out everything they’ve done wrong and focus only on the poor performance.  You can write a damaging monitoring report, cover yourself, and simultaneously ostracize the site but you will not have partnered with the site or introduced extra quality; you may be perceived as a bully or hall-monitor.

• 

  Don't "police" your sites too strictly.

  This approach is detrimental to

  quality relationship building.

  Remember that coordinators and Investigators have responsibilities beyond your specific trial.  I have addressed this in other posts such as 'Motivating Your Study Coordinators'.  If you can’t put yourself in someone else’s shoes you won’t be able to influence them to help you with your goals during the visit or in future visits.
• At crunch time you will cultivate the relationships you have built. Need access to the site at a greater frequency or increased duration?  Need your coordinator to stay late and do some extra data entry or query resolution?  If you have been friendly and respectful to date, you improve your chances of getting what you need out of your sites – even at short notice. 

2. Know your Metrics / Deliver Quality Results

What is expected of you? How do you
rank in performance compared to your
peers?  Are you accountable at work?

• You are being measured against your peers.  Approach your work in a task-oriented manner and ensure that you know which deliverables are due, when, and in what manner.  Deliver early and track your contributions. 
• Be current on all training and don’t expect a prize for meeting this basic job responsibility.  Even if “nobody else is getting their SOPs done”, stay current on yours and don’t link your performance (or failure to perform) to others.
• You’ll come to find that cultivating quality relationships and trust with your sites will go hand-in-hand with producing excellent metrics.  Focus on quality first and the metrics will follow. 

3. Raise your Flag / Get Noticed

Me me me.  Don't forget to highlight the successes
 of your supervisor and the collective team.
Contributing to other people’s happiness
 and “ team buzz” will return to you in dividends. 

• Pause and reflect as needed to appreciate your body of work.  I keep a “praise” folder in my email to store thank you notes and stories of major deliverables I have met or produced.  I reference the “praise” folder as a pick-me-up when I am feeling overwhelmed and challenged.
• Since you are always identifying your deliverables and finishing everything ahead of the deadline and tracking your contributions as I have suggested, you can provide this information to your immediate supervisor at 1:1s, in performance reviews, or in status report emails. 
• Don’t overreach.  If you are promoting yourself to your bosses boss, you may be overstepping and actually undermining your current boss or creating animosity among your peers.  Tread carefully here.  Be humble and use good judgment.  

4. Don’t Commiserate / Nobody likes a Debbie Downer

Moaning about what isn't working is easier
 than focusing on what is going well or
coming up with solutions to improve
 situations that are not ideal.
Resist the temptation to commiserate.

• Your peer CRAs may live and work in cities far away.  They will have different financial circumstances, family backgrounds, tastes and preferences, and values.  Typically the easiest common ground when forging a relationship with your peers is to talk about work and the projects at hand.  Inevitably, this will lead to grumbling or complaining about the demands on your time, or a boss who just doesn't get it, or a lead who seems checked out, or a site that is difficult to work with.   You may feel you are “just venting”, but negativity is toxic, counter-productive, and a bad attitude will adversely affect your future career prospects.
• If you have nothing nice to say, don’t say anything at all.  In every job you have to evaluate the gap between what you want from your ideal position and what you have in your current position.  It is your charge to reconcile that gap by identifying concrete and measurable outcomes that leave you satisfied.  If you simply cannot overcome the gap because of a corporate culture mis-match, timing, resourcing restraints, etc. you have to decide 1) Am I going to acclimate and deal? or 2) Am I going to bolt?  You should only be asking those two questions once you have exhausted every avenue to change your position into what you want.  These are the only two choices.  If you take things to their natural conclusion, you can stop being petulant and accept your circumstances or you can have the maturity to leave your position; either option is ultimately in the best interest of yourself, your boss, the organization, the sites, and the study patients that we are ultimately responsible to.  The scenario where you stay begrudgingly, and half-perform will likely eventually result in your termination. Your metrics will suffer, your relationships outside the office will be impacted, and you will be unfulfilled and miserable at work. 

5. Be Patient  / Exercise Humility

The best managers teach you that
you can validate yourself and
recognize your own accomplishments.

• Your Lead CRA isn’t approving your trip request within two hours of submission? Give it at least a day and recognize that you are one of a team of many CRAs that your lead manages.  This, while your lead simultaneously juggles all of the other CRA Lead and ad hoc responsibilities.  Trust that your request is in the queue and chill out. 
• Not getting the promotion you are ready for or the recognition you want after over-delivering on an important study milestone?  Keep reminding your supervisors of your contributions through status reports, performance evaluations, in 1:1s, or in a team setting. 
• Great managers always have a pulse on your contributions.  Better managers always give you credit for a job well done.  The best managers provide acknowledgement strategically; they make you wait for it to teach you humility, maturity, tact, and solidify your role in the organization.  The quality expectations are very high with the best managers and therefore they reserve praise for only truly exceptional performance.  Feedback that you have to be patient for will prove to be your most valued feedback at work.

You may also like...from The Lead CRA archives:

• How to Break in to the Industry January 2009
• Challenges to a New CRA May 2009
• Negative Performance Feedback April 2010

Summer Vacation

I hope everyone has exciting plans for the summer or at least a plan to beat the heat.  Temperatures in San Francisco were almost 75 degrees Fahrenheit this week.  I don't have air conditioning and my home is in the upper level of a beautiful Edwardian building...at the top of four flights of stairs, this has been a scorcher by SF standards.  ;)

I've planned a lot of exciting content for the blog in the coming months so I hope you will continue to follow along.  I've invited several guest contributors to help generate topics and content; I really can't wait to share some of the series' we have come up with so please stay tuned.

I will visit Guangzhou, Dali, and Lijiang this summer.
I had to get a new passport and visa because I ran
out of space in my old one - can't wait!

I am planning a vacation to Hong Kong and Yunnan province in July but I'll queue up some posts and address your comments and questions as I find time.  I've been corresponding with many of you via email but I have been on a bit of a hiatus from the official Lead CRA blog due to a lot of competing priorities at home and work; I'll include some of the topics of broader interest here for your perusal very soon.

Thanks again for your loyal readership.  You can always reach out to me in the comments section of any post or email me at leadcra-mail@yahoo.com if there are items you would like featured or if you have any monitoring questions.  Here's to a wonderful summer for all you hardworking clinical research professionals!

Beauty Break

More CRA related posts soon but today I am off-topic and burning through some birthday giftcards and shopping online.  I am going to share some of my favorite beauty buys with you loyal readers, hope this will be of interest.


Can You Get Hooked on Lip Balm?: This book just arrived in the mail for me today and I can't wait to read it!  It is from one of my favorite blogs The Beauty Brains.  The blog is dedicated to explaining the science and debunking the myths about beauty products and makeup.  It has helped me save a lot of money by avoiding loads of beauty gimmicks.  The blog has also taught me to think more critically about the products and chemicals I use on my face, hair, and that I choose to put on my largest organ, my skin.

Philosophy Microdelivery Purifying Peel: This is my once a week, brighten my skin, go-to face mask.  It combines Vitamin C and salicylic acid to promote cell turnover and leaves my skin ski-slope smooth and soft.  I have recommended this to all my friends and relatives.  Go to Sephora or Nordstrom for a sample.  I think you will return to purchase.

Bare Escentuals Makeup:I think mineral makeup is a brilliant choice for travelers.  Also it is fun to apply and provides great coverage.  

Seanik Solid Shampoo by LUSH: My color-treated hair is super fine and I sport a travel-smart bob cut but it has been dry and tired so I just switched to a new shampoo.  I realize I am a little late to the bandwagon but about three weeks ago I discovered solid shampoos.  The lather is out of this world, conditioner is optional, and it leaves my hair squeaky clean with great shine and touchable softness.  The sea salt helps with lift and the seaweed helps prevent dryness.  Buy two and you get a free tin.  I also like Karma Komba but it strips my hair too much for everyday use.  You can overuse this product so just wet it, two to three quick strokes across the scalp and then massage in.  Applying too much will make the hair gunky and leave it weighty with product.

Aveda Pure Abundance Hair Potion: I probably love this the most because of the novel application; it is just so fun to use.  You hold it at seven o clock, 4 inches form you head, and just apply a poof to the roots.  A powder mist of acacia gum turns into a creamy lotion that coats and separates the follicle to create tremendous lift. Imagine hair that has just had a day at the beach and great volume.

Cricket Professional Friction Free 1.5" Brush: I love this round brush with the ergonomic handle and tourmaline barrel.  I can blow dry my hair and set with prevision and ease.  It does not snag or rip my hair and it is less than twelve bucks. 

For more bounce these little travel hot rollers are great.
They heat up in just a few minutes and tuck easily into your suitcase.

CeraVe Moisturizing Cream: This pot of lotion creates a moisture barrier and has hylauronic acid which is important for cell turnover.  It has no artificial color and no fragrance.  It is perfect for sensitive or dry skin for daily use.  After application it isn't tacky or greasy.  

Sonicare toothbrush: I had a coupon to pick this up at Costco and I love it.  The timer keeps me honest so I don't cut any corners in my brushing and that keeps my dentist happy.  This model has a special whitening mode, a travel case, a travel charger, and a UV cleaning system to sanitize the bristles.  The toothbrush stays charged for over a week. I'm a very satisfied customer and recommend this product often to my friends.

So, I am currently looking for an under-eye moisturizer and a makeup remover. I'm also open to other great product suggestions so feel free to comment or email me your faves. I'll return to CRA topics next post. Please forgive my vanity excursion. ;)

Efficiency Tips: Keep the Inbox and Sent Box Empty....and Archive Emails Weekly

This is my Outlook folder list. I try to 

keep the inbox at less than 20 items at 

all times.

Today is Wednesday. I have received/sent and processed over 300 emails. Other Clinical Operations people in my immediate working group see even more traffic in their inbox but I can conservatively say that around 120 emails per day is my typical average. A few folks in my department file nothing and just rely on the blackberry and Outlook search functions to run their email empire. However, I feel pretty panicky if my inbox goes over about 20 messages or so. I use my inbox as my tasklist and I rely on folders and flags to keep everything organized. I've developed a system over the years to keep my inbox slim and zen-like and today I'm going to describe it to you. I also try to review and file items in my Sent box at the conclusion of every day because I prefer to file email responses with the original thread and keep my Sent box empty (Outlook can do this automatically for any message sent from any folder rather than the inbox.  In Tools->Options->Advanced Email Options-> you can select "Save replies with original message").

The batch process approach to filing TMF correspondence
Most site managers I know wait until they are preparing to close out an investigative study site then they go back and read several years worth of emails, print out the ones they think should be filed (2 copies, one for the TMF and one for the site), carry the big bound stack with them to the site, and slip it in to complete the correspondence file. An issue with this approach is that it wastes a ton of time and paper plus you are almost assured to introduce duplicates since the coordinator has likely done something similar. Finally, you are assuming that A) you have time for this exercise at the end of the trial and B) that you will still be around/employed to execute this action. Sorry to be such a realist, but both A and B are not exactly solid suppositions. My approach is to file my emails weekly in the eTMF.  As a result, at the end of every week, I am confident that 90% of my TMF correspondence is filed. I am never more than two weeks behind.

Keeping the inbox empty (or nearly empty...)
I strive to process every email within an hour of receipt. When something hits my inbox I 1) delete it 2) respond to it quickly (and delete it or archive it) or 3) file it. Deleting an email straight away will save you time from re-reading it again; dump it! If the email doesn’t require action from me and I am not waiting on a response, I can just file that email or delete it. I have a folder for my manager/HR/corporate stuff and travel. I have a folder called Praise where I keep thank you notes and email records of major deliverables or accomplishments (this is useful at review time or when I need a pick me up after a defeating day/week). I have a folder for each study I work on. I have a folder for all sites in a study. I have a few folders to keep vendor communications. I have a folder called #Pending (the pound makes it sort to the top of my folder list) for anything with action indicated from me and that takes more than 2-3 minutes to address. I have a folder called #Waiting for things other people are tasked with but that I want to track or follow-up on. I have a folder called #File for items that may be candidates for the TMF correspondence section (no, I don’t file every email in the TMF).

You actually have to Process #Pending #Waiting #File & Sent
I deal with everything in #Pending (at least the items flagged Overdue, Today, and Tomorrow) in the mornings when I arrive at work and in the afternoon when I am wrapping up for the day.

I use flags (Today, Tomorrow, This Week, Next Week) and group by flag to keep #Pending manageable.

At the end of every day (or when I have a few minutes during the day) I go to my Sent folder and I group by conversation trail or category, delete most of the thread, and move the final message to #Pending, #Waiting, #File or one of my folders. Archived in a folder = no action indicated; never to be referenced again except possibly in a future search.

I go through #Waiting at least once a week. When something in #Waiting is addressed by an incoming email message I delete the item from #Waiting or archive it in a folder.

I process #File on Fridays or anytime the folder shows that it contains more than 50 items. I group it by category or stack it by subject line or conversation. I delete everything leading up to the final thread. I typically have about 15-20 actual emails to file each week and I copy those to our TMF. I can just drag and drop from Outlook into our Clinical Trial Management System.

Outlook Features Help Me Stay Organized
I use Outlook quick steps and rules to quickly file things and/or label/categorize (if an email goes to a certain person or has a certain site name referenced in the subject then it gets a label/category automagically for that site). I use Categorize extensively (newsletter, meeting minutes, issue, login credentials, one for every PI name, specific vendor, TMF, reference, reference doc, expense report, personal). I also use search folders, too (mail received this week, mail received this month, with attachments, logins, newsletter ideas, reference, reference docs, amendment items, mail to/from specific people).

Correspondence Reconciled. Easy.
Now that you are so organized, you can actually use correspondence to prepare for your visits and write your monitoring reports. A few days before every visit, I go to the Clinical Trial Management System eTMF, select all the correspondence since my previous monitoring visit and print it to one big PDF. I open that document when I am at the site and thumb through the correspondence that has been filed by the coordinator since my last visit (the coordinator always files new stuff in front of a colored piece of paper). If the coordinator has already filed the item I delete the page from my PDF. When I am all done I email the PDF to the coordinator (remember, the only pages left are the ones the coordinator did not have filed) and ask them to print it and we file it before I leave the site.

Conclusion
I know this all sounds really intense but the system works for me and I have inspired several colleagues to adopt the system (at least in part). Try a #Pending #Waiting of #File folder. You might find that you have a useable and less intimidating inbox moving forward. Be warned however, the whole system falls apart though if you aren’t disciplined about reviewing your new #Pending #Waiting #File and Sent boxes at regular intervals. Please share any email efficiency tips or tricks that you find helpful.