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Sunday, November 21, 2010

What is up with this coordinator?

In a separate post I provide you tips and advice for motivating and working well with your coordinators.  However, sometimes it is hard to get a Study Coordinator to answer the phone, email, or query requests.  Other times they are behind on their Screening/Enrollment logs, supply requests, data entry, etc.  As a CRA Site Manager, this can adversely affect your metrics, status reports, or sense of general management for the site.  If the coordinator is a repeat offender or a general flake you will have to escalate the issue to the Principal Investigator and if necessary to the sponsor; enrollment or study payments may be held until the situation is rectified or the site may be closed.

However, nine times out of ten, I have found that lack of communication or poor performance from the site to be isolated and due to some temporary interruption/issue thereby calling for extra understanding on my part.  You never know what they have going on outside of work. For example, one time my SC was dealing with the recent suicide of his ex-wife and having to care for a new baby so all the work was slipping.  They may have recently lost a sibling, parent, friend, child, etc. and that can affect their work.  I had another coordinator who took a month off work to study for her medical licenses.  One coordinator frequently fell asleep at her desk due to uncontrolled narcolepsy.  The list of distractions/personal issues goes on and on and sometimes their workload is truly too high.
You catch more flies with honey... Bee prepared.
Never assume you have the whole picture.  Show
compassion and find out what is going on
with your coordinator.  This will make great
in-roads towards a healthy and productive
 professional working relationship.
I have always felt more compassion and understanding once I learned what was going on.  It is important not to let the situation spiral too far by keeping a pulse on your site's activities and to strike up a dialogue the moment the work starts to slip or unusual patterns/delinquencies start to emerge.  If your coordinator isn't producing or available, pin them down and ask what the issue is and whether there is anything you can do to help. They don't have to give you all the details in order for you to help them come up with solutions to get the work done.  Coordinators are pulled in many directions but you always need to pay attention and work with them to achieve the study goals.  So the take away is to be as patient as possible with your coordinator. When you are frustrated with a coordinator who is falling short, always stop to ask, "What is up with this coordinator?" so you can be pro-active, problem solve, and best maintain the relationship with the site.

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Sunday, October 31, 2010

Traveling with your Boss

So I am working on a new trial and I’ve been on 10+ trips in the last month accompanying my boss.  We’ve been traveling domestically and initiating our study sites.  I’ve enjoyed getting to know my boss outside of the office and we’ve had some memorable trips and met up with some excellent clinical staff and Principal Investigators.  I was not terribly nervous to go on the road with my boss but I did spend a little time thinking about how to prepare for each trip so we would have the best travel experience possible.  Here are some things that I considered when preparing for and completing my trips.

Be on time
Obviously don’t miss your flight but also if it is an overnight trip then get to the appointed meeting place early.  If you are in a rush or flustered you aren’t going to look your best in front of your boss.  It is rude to be late to the study site; don’t let this happen. 

Pack properly
You will feel more at ease if you are organized and prepared.  You want a small bag, not a huge clumsy suitcase.  When you go through security at the airport you want to look like a pro.  Have your baggy of liquids and your laptop easily accessible so you can run them through the scanner. Don’t forget your laptop power supply and phone charger.  Here are a few other must-haves to pack in your carry on:
  • Travel confirmations
  • printed directions to the hotel and to the site
  • GPS (program the hotel and site in before your trip)
  • phone numbers for study site and home office
  • have cash (this saved me and avoided an awkward situation on a $65 cab fare when the credit card machine was broken)
Dress well
Wear smart shoes that you can easily slip on and off at airport security.  Ensure that your outfit doesn’t inhibit you at the airport or the site (painful shoes, improperly hemmed pants, etc).  Be comfortable and dress appropriately. 

Stay busy and productive
More specifically, stay busy doing something work related (no, not solitaire).  For example, on the plane my boss dozed while I studied the Investigator Brochure, listened to podcasts about the therapeutic area, updated forms, edited the Site Initiation slide deck, reviewed Informed Consent Form templates, etc.  I suspect my boss found this more professional than if I were reading Us Weekly or watching sitcoms on my laptop. When we landed I checked my email and made quick site contact calls as we rode the shuttle bus.

At dinner you will need to limit the drinks, choose topics of conversation that are light and pleasant, and keep the jokes tasteful. Don't bad mouth previous employers or co-workers. Your boss can dish on anyone they want but you should be very careful to avoid gossiping.  You can be human and talk about kids, dogs, sports, etc, but if something is off-limits to discuss in the office assume it is not the best topic on the business trip, either.
A single glass of sangria may be acceptable but a pitcher of sangria is probably a no no in front of the big boss.
Don’t stress out
I was going to say relax but I want to be clear that you are being evaluated.  Your boss is going to observe your behavior on the trip and you need to remain professional even if the days run long.  You can still be happy and have fun but remember to stay poised.  

Traveling with your boss is a great opportunity.  Prepare for your trip and pay attention to your behavior on the trip.  If you make an error, correct it and don’t repeat the mistake. Your boss isn’t expecting perfection but will absolutely notice if you are disorganized, improvident, or obnoxious.  Have a great trip!

Check out one of my favorite blogs, Road Warriorette's take on this same topic: Traveling with your Boss

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Wednesday, September 22, 2010

Lead CRA Q&A: Investigative Site Recruitment Plan

Mumbabe said...
I am a CRA stationed in the Netherlands. I have done a lot of Pre study site visits and I was wondering how do you ask potential investigators about the number of patients they are able to recruit? Which open ended phrases do you use? Here in NL it is really a big problem as most of the data managers have to go to their database to get such info and that takes them months.

NadiaBoBadia responds...

Don't roll the dice when it comes to
subject recruitment. Asking targeted questions
will help the  PI or Site Director to better predict
how many subjects they will screen/enroll. 
Investigators can usually tell you whether they will be recruiting primarily from their own patient database, advertising (remember all adverts need to receive prior approval from the sponsor AND IRB/Ethics Committee), or whether they will be sending Dear Physician letters to their known and trusted colleagues in the area.  Ask if they will be using one or a combination of these methods.  You could also bring this up in the context of a budget discussion, "Hey Dr. Jones, you will be paid $300 for each SF but up to $3000 for every subject that completes. How many subjects do you expect your site to contribute?"

Hopefully you will be blessed with enthusiastic sites and they will meet their projections but this is not normally the case. Remember, as the CRA, you are qualifying this site (please see a related post: Selecting Qualified Investigators) so thank them for their enthusiasm but be wary of high projections that are not in line with other sites. Be sure to ask them if they see any barriers to recruitment via protocol design (inc/exc too tight, prohibited con meds will make things difficult) or facility shortcomings (no freezer to hold DNA samples, staff shortage, 5 competing protocols, etc.).

Depending on the protocol, you as a CRA can have a direct impact on the recruitment. Call the site often and check in. Refer to a relevant article that discusses motivating your study coordinators. Also make sure they are adequately supplied and that they are looking at every patient who comes through the door as a potential research subject. MDs have many competing priorities, remind them to keep the study on their radar.

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.

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Friday, July 23, 2010

3.1 oz Liquids and Gels

As a frequent traveler I have often bought 2 sets of cosmetics and toiletries so I can leave one at home and keep one group packed in my travel bag.  Lately I have been downsizing my liquids and gels even further by just carrying a 2 to 3 day portion in a pill case -- I don't really need 3.1 oz, just a few dabs of whatever product I want (lotion, cream, primer, sunscreen, cleanser, hair gel, etc) so why bring the whole bottle?

If your hotel provides products you like you can leave your full-size products at home and just use the complimentary goodies while on the road.
I've heard of other frequent travelers using contact lens cases for this purpose and I have gotten little beauty product sample cases free from the Nordstrom counter and from Sephora.  To transfer the product just use a tiny spoon/spatula or a little transfer pipette (ask your Study Coordinator if you don't know what this is or where to get one. They use them when they work with some of their lab specimens).  Last night at CVS I noticed some pretty stackable pill cases that should work beautifully.  My Amazon search today reveals that I paid the right price but I see that I didn't get any extra lids, darn!  I think I might pick up this set from Amazon instead and wanted to share the link.  How cute are these?  I just can't resist!

BTW, pill cases are also great for storing jewelry when you travel.

Saturday, July 17, 2010

Rental Car Battery Died

This week Hertz rented me a Nissan Maxima.  Like so many of the new rental cars, the key is just a fob and the ignition is just a push button (you hold down the brake and you push a button on the dash that says 'start').  When they handed me the key they asked "Do you know how to turn it on?" and I said, "Oh, one of those, of course.  They are just so nifty until the battery dies in the key fob, then they are not so cool."  In Denver some time ago I went out to the car and the little fob had a dead battery so I had to take the key apart to manually open the door and I found it to be pretty frustrating and unintuitive at the time.

Well wouldn't you know that one evening this week I returned to the rental car after dinner out and the dash was all lit up saying "no key".  I looked at the key I had tossed into the cup holder and thought, "hmmm, well that certainly isn't true."  So I got out of the car.   Locked the doors.  Walked away about 20 yards and then re-approached the vehicle and tried again.  "No key"  I tried holding down the brake and pushing the start button and nothing happened so I began to worry that I was stranded.  Then I noticed that the little red battery icon on the left was lit up and finally the dash just went dark.  I see.  So I figured that the battery of the actual car (rather than the key) was dead; I was surprised the dome light and some dash lights were still illuminated.  Having had the distinct pleasure of renting an inadequately maintained Hertz vehicle in the past I knew exactly what to do and I thought I would share this with you all so you can be prepared if you are ever in a similar situation.

Even in daylight, you need to make sure
you are safe when you approach your
car, especially in a garage.
First I looked out the windows to make sure that no weirdos or transients had approached the vehicle or were lurking around in the parking lot.  Once I determined the area looked secure I grabbed my briefcase and returned to the restaurant bar.  I felt safe in the restaurant but sitting alone in a dead car in the dark waiting for a tow truck is decidedly not prudent.  I always carry the rental agreement in my purse (specifically for this reason) and I have Hertz roadside assistance programmed into my cell phone.  From the restaurant I was easily able to call roadside assistance and provide the address of the disabled vehicle.  I was told I would need to wait up to an hour and I explained that I was willing to wait no more than 45 minutes.  The operator stated that I would be reimbursed up to $50 for a cab and I could go to any Hertz to obtain a replacement vehicle.  I had taken a map from the airport rental location and I noted that there were three other locations near my downtown location.  I rang each one but they were closed so I called the airport location.  I told them to come pick me up and bring me a new car but it was late and the Hertz guy explained he was working alone.  He told me to take a taxi to the airport or wait for the tow.

I felt safe (although inconvenienced) so I waited for the tow truck.  The tow truck easily used his built in jump pack to start the rental car.  He told me the battery would need to be replaced and I should switch out the car.  I gave him $10 tip and he said, "Oh wow, thanks, follow-me to the airport!"  So it seems maybe you aren't supposed to tip but an escort to the airport (about a 30 minute drive) was pretty cool.  The guy at the airport apologized, told me not to worry about the fact that I returned the car only half full of gas, upgraded me to a new car, and I was back in the hotel and in bed before midnight but it was a long night.

So the take aways here are: 1) Do not ask strangers for help under any circumstances 2) be aware of your surroundings 3) immediately get yourself out of a compromised situation and go somewhere safe 4) be patient, to a point 5) Do not ask strangers for help.  OK, so number 1 and number 5 are the same but it is just that important.  All the major rental car companies have roadside assistance and if you try to mess around with jumper cables or fix the car yourself you will not be paying attention to what is going on around you plus you may damage the car.  Limit your liability and use the existing process to mitigate your personal risk.  Next time you rent a car keep the contract on your person and also program the roadside assistance number into your cell.  Happy travels!

Monday, June 14, 2010

Blogroll! Plus a Sampling of Podcasts

I spend a lot of time hanging around in airports, bored in different hotels, and riding in airplanes since I do travel to work.  My favorite ways to pass the time are to catch up on email, read the news, read books or wikipedia, or dart through online blogs that interest me.  When I am too tired to read, I can have online content delivered right to me with my iPhone and podcasts.  Here are some of my blogs, and podcasts that you may like to check out.  Please email me or leave a comment if there are oher blogs or podcasts you can recommend I check out - I'm always happy to give new content a try.

Blogs: You can read blogs via RSS feed (add them to your myyahoo homepage for example), have them emailed to you in digest format, or have them aggregated into a feedburner or feed reader.  I like  I access my blogs from multiple devices (PC, iPhone, iPad, etc.) but google keeps track of exactly which ones I have read and allows me to sort and filter the content on the fly.  I even subscribe to the comment feeds for some of my blogs and google keeps that organized, too.  Reading online content at 30,000 feet is an issue if the airplane doesn't offer internet service but I am hoping I can overcome that with a scraper service like readitlater...I just need to be home for more than 20 minutes one day to figure out how it works and get it setup.  Please keep reading my blog and also consider checking these out:

Clinical Research Industry Blogs:

Frequent Traveler Blogs:
For Fun:
  • The Beauty Brains - Dispelling myths and marketing messages about cosmetics with a little but of science.
  • Corporette - Geared towards female lawyers but broad enough that I still enjoy my free subscription anyway.
  • - Reviews of some off the beaten path (mostly inane) iPhone applications.
  • The MUNI Diaries - Tidbits and observations on board public transportation in San Francisco.
  • The Richmond District - All about a specific neighborhood in San Francisco.
Podcasts:  You can find podcasts on any topic from cooking, to travel, to comedy, or anything else that interests you.  Plus they are FREE!  There are even video podcasts available.  I listen to way more podcasts than I listen to music and I listen to most of my podcasts on doubletime.  You can speed them up and listen to twice as many plus everyone sounds so funny like a chipmunk, it just never gets old to me!  I even plug my iPhone into the rental car and listen to podcasts when I am stuck in LA traffic or driving long distances.  Theoretically you can listen to podcasts while working out, but I never quite make it to the hotel gym when I am on the road. ;)  Here is a sample of some that I subscribe to:

Thursday, June 10, 2010

Investigational Product Accountability

Clinical trials are conducted for new investigational products and also to explore additional endpoints/indications for marketed products or combinations.  The medication dispensed in the clinical trial is governed by country/local requirements and strict regulations dictating that it must be tracked and accounted for throughout conduct of the trial.  There are also regulations regarding how the medication is packaged in order to protect the safety and welfare of the subjects and also to maintain the integrity of the trial.  The guidances and guidelines (ICH GCP Guidelines 4.6) spell out recommendations for labeling, packaging, transport and storage.  Suffice it to say, the investigator is on the hook (although he may delegate some of this responsibility to a pharmacist or another person qualified by skills and experience) for confirming receipt of the investigational product (IP), storing/dispensing it properly, and ensuring subjects are compliant with the specified regimen.

The gold standard in clinical trial design is the blinded placebo controlled trial; in these studies the subject and/or the investigator doesn’t know which treatment is being given and that helps maintain objectivity and reduce bias when assessing safety and efficacy. Reference the FDA website for information on various types of trial designs. In order to maintain the blind in the study, the sponsor will deploy a system to disguise the active treatment and the comparator (achieved through manufacturing, opaque packaging, etc.) but also allow identification of the product(s) in the event of an emergency.  Many trials use an electronic randomization system with controlled access so that drug can be assigned according to a pre-determined stratification (to balance inventory across multiple study sites) and also to provide a record of any blind breaks.  Alternatively, trials may use sealed paper randomization envelopes and/or unblinded monitors.

The investigator needs to maintain records of shipment receipt and records of accountability for the disposition of the investigational product throughout the trial. Investigation product may be provided to the investigator in the form of blister packs, sealed bottles, syringes, inhalers, or some other delivery system.  The investigational product will have storage specifications in accordance to the instructions from the sponsor and applicable regulatory requirements.  If the investigational product is temperature controlled, it may be shipped to the study site with digital data loggers that monitor and record the temperature during shipping. The investigator will also need to demonstrate that the temperature has been recorded and maintained according to specifications since the time of receipt (using a paper log, digital device, or some other documentation).

Once the investigational product is at the site, as monitors we can review expiration dates and inspect the product regularly and document the inspection in our reports.  We need to check that everything that was supposed to be used is not present (counting the used IP and reconciling our counts against the tracking documentation), and also that everything that is supposed to be intact has not been used.  We can also physically check that blinding envelopes plus unused investigational product foils and seals are intact and have not been tampered with.  We will review the temperature logs to record and report any temperature excursions.  We will also verify that there is restricted access to the investigational product; controlled with double lock and key.  Finally, we can review the schedule of planned activities at the site and ensure there is adequate supply of investigational product to support continued research efforts.  We will record any deviations or discrepancies and report to the study team and retrain the study personnel as appropriate.

This red tamper-evident tape reveals the word "opened" if you lift and replace it.
Repeating the accountability exercise at every visit can be a time consuming process. If it isn’t stated in your study monitoring plan, ask your Project Lead if interim return/destruction of the used/expired investigational product is permitted.  This is certainly advantageous to waiting until the end of a long study and then trying to reconcile all the paperwork and re-count everything.  As an alternative, you may choose to box up the used investigational product and seal the box with tamper evident tape (at all seams) or just put the tamper-evident tape completely around the investigational product packaging itself and leave it in the controlled secure IP storage area to verify again at the next visit (though this will likely take more tape and it is actually kind of expensive. Also consider initialing across the tape or signing your name so any tampering will be additionally evident).  With your study team’s permission, this may be sufficient to avoid recounting all the investigational product at every single future visit, hopefully they will provide permission for you just to review that the taped up IP is still present and unaltered.

Occasionally drug will be transferred between investigational sites.  This creates a flurry of documentation and if you are asked to participate in a drug transfer you will receive plenty of training from your study team so I will just move on now.

At the conclusion or termination of the trial or in the event of a recall, the investigational product (and the blinding envelopes or supplies if applicable) will be returned or destroyed as specified by the sponsor although sometimes it may be donated to a hospital, pharmacy, or doctor. Per ICH E6 8.4.2 there are requirements for documentation of investigational product(s) destruction.  Any drug or packing that was not returned by the study subject will be documented on the accountability log and it is recommended that there also be documentation in the source documents of counseling the subject on the requirement to adhere to all protocol procedures and instructions.  Documentation regarding the receipt, disposition during conduct, and return/destruction are to be kept on file in the Site Master File and the Trial Master File (your study team, SOPs, or monitoring plan will inform you which file gets the original documents and which gets the copies).  OK, a lot of material here, please let me know if there is anything you want me to clarify or expand further on.

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Saturday, May 22, 2010

Employment Reference

One of my colleagues and close friends recently lost her CRA position due to a large round of layoffs at our former employer. I was aghast that she was let go and I felt terrible for the sponsor since we had worked on the same trial here in California; the former team of six was now reduced to just one. The sponsor tried to hire her directly but the CRO refused to allow her access to the clinical trial management system and replaced her with a Junior CRA located on the East coast. I comforted my friend and offered myself as a resource in her job search. I think her work is of the highest caliber and given the opportunity to work with her again, would do so instantly. She has been a great mentor and is truly a talented and dedicated CRA. I contacted all of my trusted recruiters, referred her to my current company, and provided resume and interview advice. Not too long after, a hiring manager contacted me to discuss my friend’s background and experience. I was prepared for the call and gave an excellent reference (if I do say so myself).

Here are the employment reference questions the hiring manager asked me about the person I was referring:

  • Describe the employee’s technical and industry skills.
  • Is the employee good at resolving problems?
  • How does the employee adapt to using new tools/systems?
  • Does the employee demonstrate compliance to regulations?
  • Have you observed the employee struggle with time and expense reporting policy?
  • Describe the employee’s site communication style.
  • How does the employee interact with peers?
  • What do you think of the employee’s written expression?
  • Do you have anything else to add?

So who should you provide as references? The company you are applying for may want to speak with specific people, but typically they will be happy to chat with a supervisor, a peer, and a personal reference. Supervisor doesn’t actually have to mean your current boss (especially if you are trying to keep your job search confidential or you don’t trust your current boss to promote you well enough). You should provide someone with supervisory responsibility for your work. This could be a line manager, dotted line supervisor, or even a project manager who maybe didn’t directly supervise you but was very familiar with your day-to-day performance and responsibilities. Secondly, I like to provide a peer who is at the same level or slightly higher than me in the organization and who has observed my work in the field. For the third reference, I like to pick someone from a different functional group in the organization or a strong personal reference. For example, I might ask someone from legal, accounting, or data management that I have worked closely with or maybe someone from a professional organization like ACRP or someone who I have volunteered for or with outside of the industry to serve as a reference.

How do you ensure your references are prepared? Ask them if they are comfortable being your reference. Pick someone who is responsive and willing because if the hiring manager can’t get in touch with your references, this could interrupt the offer process (trust me, I know from first hand experience). Then, meet them for coffee or schedule a telephone call or short meeting to help them prepare. Provide them a copy of your resume, a copy of the job description you are applying to, and a list of skills and past successes you want them to highlight. Explain to them why you are applying for the chosen position and what special strengths and relevant experience you think you offer. Request that they write up and post a recommendation of your work for LinkedIn or do a practice run with you so you know you are comfortable with what they are saying. Ask your reference to let you know if they are contacted and get feedback on how it went. Genuinely thank your reference afterwards with a hand written note, a meal out, or a small gift or giftcard.

I am happy to report that my friend has been snatched up by a wonderful company; talented people don’t last long in the marketplace. She is enjoying her new assignment and especially pleased about her 15% raise, did I mention she is a great negotiator? Being laid off can be extremely rattling, but if the quality of your work stands on its own, remain positive, reach out to your network, prepare sufficiently for your job search, help your references prepare, and trust that things will work out.

Friday, April 30, 2010

And the Clinical Researcher winners are...

Last Fall I wrote about the Inaugural US Clinical Researcher Competition offered by PharmaTimes and sponsored by several notable pharmaceutical companies and CROs.  The competition is a peer reviewed challenge to recognize excellent performance in clinical research.  They are specifically filtering for the ideal mix of core clinical expertise and interpersonal communication skills that are vital for successful collaboration in clinical trials.

There were categories for CRAs, Project Managers, and Study Coordinators.  Challengers were nominated to participate by their colleagues.  The first phase of the competition was a 40 item online questionnaire that focused on ICH/GCP.  Successful candidates were then invited to write a role-specific essay which was anonymized and reviewed by a panel of judges. The judges narrowed their selections in March to five to eight finalists across America for each category.  The finalists traveled to Philadelphia yesterday for the final presentation to the judges and the subsequent awards ceremony.

Congratulations to all the finalists and a special thanks to all of the sponsors, supporters, and the PharmaTimes competition organizers.  Please follow these links to learn more about the candidates and the winners.  In particular, the bronze award winner in the New CRA/Site Manager category seems especially familiar to me:

Category Winners:

Category Finalists:

Thursday, April 8, 2010

Lead CRA Q&A: Dealing with Poor Performance Feedback

Anonymous said..

I understand the productivity loss, time, costs, etc of choosing an inadequate site; however, what are the ramifications against a CRA who chooses a site that turns into a "dud" site? -APRIL 7, 2010 2:00 PM

NadiaBoBadia responds...

Wow, this is a challenging question.  I only choose great sites that end up as top enrollers and execute the protocol flawlessly so I am completely unqualified to answer - ha!  In all seriousness, I think that in any job or task where you can demonstrate that you performed methodically, deliberately, and intelligently the study team would be hard pressed to fault you in your efforts.  If you build a strong reputation for yourself through quality work and your team trusts you, the backlash from these types of issues will likely be minimized but you still may find yourself "on the hook" for a poor performing site.  During my site selection efforts I keep a log of my activities and communications so I can reflect back on the process 1) to look for potential efficiencies for next time 2) to serve as a training tool for Junior CRAs that I mentor and 3) to demonstrate/remind myself/others that I was diligent and thorough in my original efforts (my colleagues and I lovingly refer to this type of documentation trail as CYA).

If I am called to task on poor performance, I will have some documentation to defend my actions, explain my thinking at the time (hindsight is 20/20), and deflect some of the backlash.  This is a delicate line because you want to explain the history behind errors but you need to be careful not to dwell and beat yourself up too much.  You have to move forward and get recruitment back on track - be proactive and start brainstorming solutions.  Just like we tell our study sites, you acknowledge the issue, you create a plan to avoid the issue in the future (obtain guidance and re-training as appropriate), and you implement that revised process.  So you picked a "dud" site, coach them, encourage them, and try to salvage things if at all possible.  How cool would it be if you worked hard enough and your problem site transformed into a model site?  If all else fails, the study team may elect to close the site and focus efforts into better performers but I hope you have been tracking your site correspondence and have been a good site manager and partner (and can prove it with documentation).

Only an unreasonable employer expects you to perform perfectly at all times.  The best we can train for is to develop a toolkit of monitoring skills and a clin ops intuition for making the best decisions.  At the end of the day, we are human and fallible and need to be able to accept our failures when they do happen (and they will happen, this can be a challenging job).  That said, someone does sometimes need to take a fall and as a CRA you may be grilled or disciplined by the study team.  You may receive poor performance feedback at a review or have an uncomfortable conversation with your supervisor or study team.  In my career,  I have known CRAs who were yanked off of trials or "sacrificed" for political reasons not necessarily performance reasons.  I've witnessed CRAs be unfairly scrutinized or singled out in meeting/telecons for site performance issues that were more or less out of their control.

Having your work or ideas criticized can be humbling and may not be warranted, but it is bound to happen at some point.  I hope for every CRA that negative feedback is always delivered respectfully and constructively.  When your work does not meet your employer's expectations, limit the excuses, graciously accept that feedback, and improve. A mistake can be devastating or it can be a development opportunity.  In other words, you can't undo errors, but you absolutely have complete control over how you react and recover from a mistake.  I keep track of my successes at work in an email folder called 'Praise'.  For example, if I get a note from a peer or a higher up complimenting my work, I file it away for later.  Reviewing the items in the 'Praise' folder is a great pick-me-up when I've had a challenging day or even to share with my supervisor when we are reflecting back on my overall performance at review time.  I've veered a bit off topic but I hope my thoughts on dealing with poor performance feedback are helpful and have addressed your question.

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.

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Saturday, April 3, 2010

Selecting Qualified Investigators

The focus of this post will be selecting adequately performing US clinical trial sites for Investigational New Drug studies.  Depending on the nature and size of your clinical trial, you may be targeting private practices, specialists, academic centers, purpose-built dedicated clinical research facilities, or a combination of any of these to find your principal investigator(s) (PI).  Certainly, there is great cost associated with opening and maintaining a study site so you are well advised to be thorough and thoughtful when evaluating the potential investigators.  As monitors, we may provide input on the clinical operations of a study and assist or manage projections of how many and what types of PIs will be selected and this article will discuss some of the important considerations for qualifying and selecting study sites.
As qualified CRAs, we use our instincts and training to predict and choose the most qualified and motivated PIs.
Inevitably, some study centers will perform better than others and deliver the ideal study candidate while strictly adhering to the protocol.  Careful site selection is absolutely critical to limit the time and resources that will be required during study conduct to manage poor performing sites; I refer to my non-enrolling or poor performing study centers as “duds”. Duds require additional monitoring oversight, coaching, and avoidable cost for continued participation, therefore, these sites are often closed before enrollment or conduct is complete.  Closing a non-performing site is an attractive option to suspend the siphoning of time and resources, but forethought and a well-coordinated site selection exercise can help ensure dud sites are never opened in the first place.
Consider the therapeutic area of study and recruit PIs with relevant experience, the right study tools and equipment, access to the target subject population, interest/motivation to recruit, and availability to participate.  

You needn’t only consider PIs with prior clinical trial experience, but you may gain some considerable efficiencies by targeting PIs who have performed well in prior studies and audits.  Some PIs pay to be listed in clinical trial directories, you may be able to obtain names of doctors to approach through online physician directories, reviewing PIs you or your colleagues have worked with in the past, internal company databases, conference attendee lists, patient advocacy groups, journal article author searches, pharmaceutical sales personnel, medical association websites, telephone directories, the internet, trade journals, other networking contacts, etc.

The FDA maintains lists of disqualified investigators and those that are prohibited or restricted to conduct clinical trials.  You can also review any previous warning letters or license restrictions using publically available databases (Click on the hyperlinked text and see additional links below for further information).  Your investigators will need to adhere to all ICH/GCP guidelines and relevant CFR sections including 21 CFR 312.53.  Check your potential PIs against these lists and also gather anecdotal information regarding the investigator from colleagues and the internet. Read physician review websites like or clinician directories.  Determine if there have been previous inspections at the study center.  Some doctors have their own websites and you can also search news databases to find information about a potential PI you are considering.

Finally, you can contact the physician and his staff to inform them of the trial, determine their interest, and request that they fill out questionnaires or provide a copy of their CV or a summary of their experience.  If you do develop site selection questionnaires you can ask them for their input on the trial design, to describe their facility, to quantify their qualifications/experience/availability/resources/staff, to identify if they have the proper equipment, to comment on their previous clinical trial or audit experience, to give details on their IRB process, to project potential recruitment and access to the target subject population (double check that there aren’t competing trials at the facility or within the same geography, to detail translation and advertising needs, and to inform you of any anticipated barriers to recruitment.  Much of this work can be done via telephone/fax/email but you may want to schedule a time to visit their office and evaluate whether they are a fit for your trial. For more information read my post on Pre-Study Visits.

Beyond the questionnaire, you can use the site selection process to gauge the communication style, organization, and responsiveness of the site staff.  
Beyond the questionnaire, you can use the site selection process to gauge the communication style, organization, and responsiveness of the site staff.  Ensure there are no conflicts of interest, lack of objectivity, or other reasons to avoid a specific PI.  You will be able to determine the PIs experience conducting other sponsored trials, develop a feel for the turnover at the site, and sniff out any additional red flags that may steer you away from choosing that site or anticipate issues that might creep up during conduct.  Be tactful, gracious, and considerate of their time.  The PI will be evaluating whether they want to work with you as well.  It is very much a two-way street since you may be working closely together for a considerable amount of time if they do join the trial.

Good luck selecting qualified investigators. Definitely take the time before the trial starts to be thorough and deliberate with the site selection process.  There is always pressure to get sites up and running as quickly as possible, but you must balance that need with the requirement to spend adequate time selecting qualified investigators. Hopefully spending enough time choosing your PIs will ensure your trials will be easier to enroll, your studies will be conducted with less protocol deviations, and your study team will be more likely to avoid unnecessarily costly “dud” sites and achieve all of your study objectives.

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Wednesday, March 10, 2010


I've got some great new content planned for the blog through the end of 2010.  In fact, I have about 30 draft posts started, I'm going to add a picture gallery of hotels and travel items, and my next topic will be "Selecting Qualified Investigators".  I just haven't been able to focus on polishing off any of the articles yet but please look for an update again before the end of March.  Sorry for the hiatus but the end of 2009 was a bit rocky and 2010 has been BUSY.  The climate last year was awfully uncertain at my old company despite a fabulous boss and a balance of interesting assignments so I needed to make a change.  I accepted a position at a different company last November and they have kept me occupied learning all the new systems and refining my monitoring skills.  However, I was able to take a relaxing vacation recently and I am totally restored.  I am now back in the office and getting organized.  Once I check off my to-do list at the day job I will spend some energy back here on the blog.

I just wanted to send a quick update to let you all know that I am very very happy, healthy, and excited about getting back to blogging just as soon as possible.  Thanks everyone for your continued readership plus all the comments and emails.  Please let me know if there are specific topics you want to see so I can prioritize everything I have on the back burner.

Wednesday, January 6, 2010

New Year, New Destinations, New Perks?

I'm out on my first work trip of the year performing a few Site Initiation Visits for a new drug study in Southern California.  I've definitely logged some serious miles flying SFO->LAX in my time monitoring but hopefully I'll have more sites soon in some locations that are new to me (but not anywhere it is snowing...fingers crossed).  So how do I keep my trips from becoming too routine and how do I avoid travel burnout?

In every city I seek out interesting new restaurants to try and explore the area as much as possible when I have to overnight.  I'm fine to dine alone or go to a movie alone, and I rarely if ever take meals at the hotel.  For restaurant recommendations, I research on the internet, ask my site personnel for tips, or I use an iPhone application like Urban Spoon or Yelp to get my bearings.  Last year I earned 20,000 miles on my preferred airline just by dining at restaurants they recommended on their website and for registering for all the promotions (that is basically a free roundtrip ticket in the US, so not too shabby just for routine within policy dining).  If I have a fabulous dining experience I will review it on the internet but I rarely dine again at the restaurant - I just love trying new things and find that a great dining experience is always better in your memory than when you return and try to relive it - it just never seems to meet my expectations the next time.

I always have my camera ready in case I come across anything out of the ordinary.  When I see this cactus I remember a visit I did to Tucson, AZ. I was bored one evening so I went and found a new hair dresser.  Her name was Aqua!
I also love it when I visit the city of a friend or co-worker and we can meet up for shopping, touring, or dining after work.  Viewing a city with a local's perspective is such a wonderful opportunity and I am lucky to have met up with friends and family at various times while on work trips in the past.  I've even been known to have buddies from home tag along and kick back around town or in the hotel while I am out at work all day.  Then in the evenings we meet up and check out the city together.  These trips have all been so memorable and special for me and I'm lucky to have a great job that allows me to travel and have so many wonderful experiences.  Maybe I'll feel differently in 5 or 10 years but for now I am not road-weary at all.

I can't recall whether I have mentioned on the blog before, but one wacky thing I do is to stay in a different hotel every night.  This is one part for safety, one part so I don't get bored, and one part to satisfy my lust for hotel points and miles (top tier loyalty program status is awarded based on number of stays so if I am in a city for 3 nights I will stay at 3 hotels just to race to obtain the highest status - once obtained I challenge in a different hotel chain or chase hotel promotions as they come along).  Most monitors I talk to about this just shake their head in disbelief and laugh, but I just can't imagine staying multiple nights in the same hotel - that is really not for me.

My favorite part of travel are the unexpected perks and little upgrades and freebies along the way (no, I don't mean hotel soaps and lotions - oh but I still collect them sometimes when they are really nice - but how many of these can a girl really use?).  I like the little things, like an extra bottle of water in my hotel room, or a fuzzy robe and slippers, or the radio on when I enter, a call from the front desk to check that everything is satisfactory, or chocolate truffles on my pillow - yum!  At dinner last night I was given an ocean view table, the waiter addressed me by name, and he treated me to a free dessert.  Occasionally I'll get a snazzy complimentary upgrade on the flight, at a hotel, or in a rental car.  I especially love upgrades or token gifts that are unusual or surprising.  Last year for my birthday my regular taxi driver suggested a San Francisco restaurant to celebrate with my friends.  He made the reservation and arranged for gratis champagne waiting upon my arrival.  There are sacrifices for being away from home so often but I appreciate how the little gifts help keep things in balance and fun.
This free fruit basket was provided in my room at the Universal Studios Hilton in Los Angeles because I was staying there very often.

A Doubletree in Denver gave me some trail mix and cookies
to go with my free bottled waters.
Happy New Year everyone!  Here is to a 2010 filled with many exciting new destinations (or new looks at old ones through new hotels and restaurants to try) and many many perks along the way.  Leave a comment and let me know how you have been rewarded in your business travel or how you avoid slipping into a routine while out on the road.  Safe travels!