Monitoring Visit Follow-Up Letters

You’ll send a confirmation letter (or email if your SOPs allows it) prior to every monitoring visit, be it a pre-study qualification visit, a site initiation visit, routine monitoring visit, close-out visit, etc.  Then you’ll need to document your visit findings in a monitoring report.  Finally, you will send the principal investigator a follow-up letter summarizing the visit and discussing any critical findings or action items.

Create Your Monitoring Visit Follow-Up Letter

As a rule, I try to keep the follow-up letter to no more than two pages.  It is best practice to have the letter completed, reviewed, and sent within 7 days of the visit.  I write the letter to the Principal Investigator (PI) but Cc in the coordinator and trial TMF and/or the regulatory person, my Lead CRA or Project Manager, etc. as appropriate per my SOP.

your Lead CRA or the Sponsor may want
to approve the letter or provide a study-specific
template so check with your Lead before you send it

I dedicate the first sentence to listing the personnel who were present at the visit and thanking the study staff for their time and attention during the visit.  Be sure to include the dates of the visit as the letter will be filed in the Site Master File and the dates should match the Monitoring Visit sign-in log dates.  This is a good point to discuss any staff changes or recommended re-training.  Next I typically document the progress of study enrollment and then proceed to summarize the status of the Site Master File review, source data verification, and Case Report Form completion.

A Summary, Not a Novel

I break up the content where possible by using in-text tables or bulleted lists to note the following items as appropriate per the trial monitoring plan and SOP:

• Informed Consent tracking details
• Summary of patients/Case Report Forms reviewed
• Site Master File or Source Documentation deficiencies/inconsistencies or Safety Findings
• Protocol Deviations or Critical Findings (and appropriate recommended corrective actions as discussed with my regulatory contact, PM, or Lead CRA)
• Supply Issues: lab kits, Investigational Medicinal Product, source documents, etc.
• Action Items: resolved since last visit, new pending and wherever possible

No Surprises

My most important tip for follow-up letters is, “no surprises”.  During your time on-site you should be meeting with the PI and discussing the status and progress of the visit.  You should be summarizing your findings and discussing any issues so they can assist you to resolve everything while you are on-site.  If there are deviations or safety issues that need to be reported to the IRB, you can remind the Investigator of their responsibility to do so.  You can also provide re-training on the protocol or study procedures during your meeting on-site.

The Follow-Up letter should be
a recap of your discussion, not a news flash.

In regards to action items, it is best practice to resolve everything before you leave the site to the extent possible.  I have extended monitoring visits to an additional day with approval from my Lead when there were items I would be able to complete with an extra half a day or so rather than leave pending.

If you are unable to meet with the PI during the visit, document this in your follow up letter and include a reminder that you are available by phone to speak with the PI.

Follow-Up Letter Template

I’m not planning to post a template.  Please don’t email me for a template as you can easily make your own using the guidance from this post that is study-specific for your trial’s needs.

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

• Meeting with the PI August 2011
• Routine Monitoring Visits March 2008
• Close-Out Visits July 2008

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

Monitoring Visit Checklist

I participate in a number of clinical research forums and I just received an email digest this week from one that linked to a monitoring visit checklist of sorts. Many of you have emailed me and left comments asking for a checklist but I can't figure out how to post one on blogger. Instead, please review Norman Goldfarb's Journal of Clinical Research Best Practices here and download his checklist or read my post about Conduting a Routine Monitoring Visit.

Norman M. Goldfarb is Editor of the Journal of Clinical Research Best Practices.

You can subscribe to his updates here and I think you will find them as useful as I have over the years.

Monitoring Visit: What to Pack

I came across a nice online article recently by Greig Waddell with tips on how to save time when traveling for business. Click here to check out the full article. I thought all of his points were great but I wanted to expand upon it a bit in the context of traveling to a monitoring visit.

So you are going on a monitoring visit. You want to dress sharp and have all the supplies you need. Choose clothes that you can mix and match, that you don't have to dryclean or iron, and that are professional and appropriate. I travel 2-4 days each week so I pretty much just keep my suitcase packed all the time and just replenish/rotate things out for cleaning as needed. This means two sets of toiletries, those I use at home, and those that always stay packed in my 3-1-1 TSA approved baggie. Staying "packed" has saved me on several early mornings when I haven't exactly given myself quite enough time to get up, get out of the house, and get to the airport. Here is a selection of my luggage:

No, I don't travel with 3 bags. Click here and then scroll over the photo at my Flickr site to learn more about what type of luggage I use for different length trips.

I don't check bags with the airlines, but if you do, don't check valuables like expensive jewelry or your laptop. Don't forget that sponsor proprietary information including protocols and regulatory documents are extremely valuable. If you can't carry all your documents, FedEx them to yourself, but NEVER check them because luggage can get lost.

I try to carry as little paper as possible - if the sponsor doesn't provide you with a pocket sized spiral-bound protocol book, Kinkos or a similar copy center will make you one for less than $50 and you'll be glad to have it plus you can probably get reimbursed for it on your expense report (check with your lead first). Remember that you may need to retrieve copies of documents at the site so bring some kind of inflexible folder so they won't get damaged or bent in transport. Other documents I like to bring electronically or carry with me (good to review on the airplane) include the MV Checklist, study contact list, print-outs from the IVRS, and old monitoring visit reports/pending action item lists. So you can follow the links below to find out more about what is in my bag:

More details and photo notes available at my Flickr page.

Click here for a copy of a printable checklist that helps me pack for monitoring trip. It is in MS Word so you can download it and edit to your specifications. Send me an email if you have any trouble downloading the document and I will forward you a copy.

Please also check out my travel tips section for more info.

Efficiency Tips: Spend less time on your Timesheet

I am employed by a service company and we bill our clients for our services. Therefore, we must track our time spent on sponsor related work and pass the costs through appropriately. I am asked to track my time in 15 minute increments so I can basically report up to 4 time categories per hour or I can bill a half or whole hour to a specific time code. In order to receive a good performance rating, I must report at least 85% of my 40 hr work week as "billable time".

My non-billable time codes are things like: Sick, Holiday, General and Administrative Duties (G&A), Internal training (not project specific), goofing off (ok, so that is not a category but if ever I am shy of 40 hrs and can't account for the time then G&A is a good catch all), etc.

Billable time is coded by project (since I might work for several sponsors/projects at once) and then broken down into time categories as follows:
Project Specific Training / Sponsor Teleconferences - Reading protocols, watching power points, reviewing the Monitoring Plan, etc.
Preparing and Following Up - This category is used for making travel arrangements or writing confirmation/follow-up letters, or working on reports.
Traveling - Usually your project will have limits to how much travel time you are allowed to pass through. At my company, when long trips are unavoidable, you can lower your travel time by using the time in transit to complete other project related work such as studying or writing reports (billable to either of the 2 categories listed above) - obviously this works when on an airplane or delayed and not necessarily when driving!
Managing Sites - This is phone or email contacts to your study sites or running special project specific reports.
Conducting a Monitoring Visit - Actual time spent on site during SIV, COV, or routine MV.
Query/Database Management - Helping the site solve/close queries raised by data management, reviewing the clinical database, running reports, etc.
Expense Reporting - see my next post!

OK, so now that I explained how I categorize time, let me explain the time tracking system. You can think of it as a glorified version of Excel that lives on a web server. So to enter my time, I have to log into that system and enter all of my hours. We are asked to do this at the end of every day so we are as accurate as possible. Well, I don't have internet access all the time so sometimes I let a few days pass and it really is hard to remember what you did for the past 48-72 hours by 15 minute increments. To solve this conundrum, I made a copy of the fancy web-based timesheet template in Excel and I just leave it on my desktop. Each day before I log out of work, I update my time in my Excel template. Then every 2 weeks (or as I have time) I log into the web-based system and transfer it all. I know this is multiple steps but it seems to work better for me. You could also use a journal or jot notes about how you spent your time in your day planner. Any other tips?

Efficiency Tips: Spend less time on Monitoring Visit Reports

As a monitor, you may visit several different study sites in a single week and possibly for different protocols. I often find when I get home from a trip like that it is hard to write my report and keep the details of the different sites straight. One thing I have done to successfully overcome that is to draft my report before I even do the visit. On most studies, your Lead will provide you with a template report that you will need to complete following each visit type. You might also use an electronic system to create your reports but luckily, mine are usually just MS Word templates. Every report is guaranteed to have a header section that includes the MD name, facility name and address, visit type, visit date, date of last visit, and list of attendees. You probably know all of this information before you step foot on the site so just fill it in before you go.

Things I am unsure about I highlight in yellow so I remember to return to them later. Unless this is your first visit to the site, chances are there is a previous report completed by either you or another CRA that has items that probably need to be carried over to your current report. You will want to refer to your company's SOPs and your project-specific monitoring plan to know which items get carried forward. On some of my recent reports, this has included Enrollment data (I can usually get the current number of Screened, Screen Failed, Enrolled, Early Term, and Completed subjects from the IVRS system before I even show up for the visit), summaries of Protocol Deviations to date (they stay on the report until the IRB acknowledges receipt of the deviation), SAEs that are not resolved, Regulatory Documents that need to be collected, and pending Action Items or those that have been resolved since the last report date.

Drafting your report before the visit has the added benefit of helping you write your confirmation letter and get a grasp on what activities need to take place during the visit. You will be organized before you get there and more likely to monitor efficiently if you know exactly what is outstanding.

While you are at the site, avoid keeping notes on notebook paper; just write pending items directly into the Action Items or other applicable section of your report. If the items you notes are resolved by the time you leave you may decide to dump them from your report (depending on how much detail your company/sponsor is looking for) and if not, mark them pending and submit them as part of your draft.

When I am at the airport waiting for my flight to board, I can usually knock off a draft report in about 20-30 minutes. Then when I have internet access, I just submit it and forget it (or at least until I get a revisions request)! What efficiency tips work for you?

Not getting any work done in the airport terminal?
Your company may reimburse you for airport lounge
access or you can typically get a discount pass through
loyalty to an airline or credit card offers.  In the lounge
you can be productive, enjoy snacks and beverages,
access the internet and a business center plus plug
in all of your devices.  

Routine Monitoring Visits

Routine or Interim Monitoring visits are basically any visit that occurs after the site is initiated and up until the site is closed out. As monitors, we visit our sites periodically to ensure that they are compliant with all the regulations, subject safety is being adequately followed, data is being captured in a timely and reliable manner, the Investigational Product is being handled as per protocol and relevant regulations/guidelines, there are no significant deviations from the planned study protocol, all important study documentation is being generated and stored properly, and that the research site is adequately supplied in regards to lab kits and other pertinent study materials. The ultimate purpose of our job is to protect subject safety by monitoring the trial conduct for ICH/GCP compliance.

When planning your monitoring visits
it is helpful to have a reasonable expectation
of how think the medical records and source
documents will be. Know in advance how much
you will need to review so you budget enough
time to successfully complete your objectives.

Your agenda from visit to visit may vary slightly based on the length of the study and how many times you plan to visit, the amount of time you spend to plan at the site for this particular visit, the site's progress to date (if a site has yet to enroll any subjects you surely won't have any CRFs to review or pull), and where you are at with the general monitoring plan (for example, drug accountability may be done all along or just at close-out).

Prior to your visit you will contact the site to set up a suitable time for your visit. Visits typically last a day or two. Ideally, the PI would be available to meet with you during the visit. You will send a confirmation letter to the site once a date is set (be sure to confirm the address before you go if you haven't been there before!). More often than not, your study lead will provide you with a monitoring visit checklist or at the very least, a monitoring report template so you will know exactly what tasks you are expected to perform on-site and what topics to cover. Here are some of the specific tasks that are routinely performed at these visits:

1. Informed Consent Form (ICF) review: You are ensuring that every subject was adequately informed and consented to the study before any study procedures were completed (I recommend checking lab draw times and ECG times - if required at the screening visit - against the consent time to be extra sure that the consent was the first study procedure to occur). There are other state specific regulations you will need to know and monitor for. For example, in some states subjects must be 19 to participate and in California every subject must sign the 'CA Bill of Rights' document, etc. Sometimes there are multiple versions of a consent due to a change in the facility address or the details of the protocol. Ensure that all subjects signed on an IRB approved version (each page will be stamped in the upper right hand corner and the version date will be printed on each page). Proper consenting of subjects is critical to ensure the security and privacy of health data and that subjects are adequately informed of the study procedures, risks and, benefits. If the consent is not signed or properly completed inform the Study Coordinator and do not review this subject's medical chart until consent has been properly obtained.
2. Check for Serious Adverse Events (SAEs): Per the guidelines, an SAE is any untoward event that results in death, prolonged or new hospitalization (longer than 24hrs), significant disability, or congenital anomaly (birth defect). If the event has not been reported, assist the Study Coordinator in doing so and inform the sponsor immediately.
3. Review Protocol Compliance: In your chart and source document review, you can verify that subjects were sign at the right times and the right procedures were conducted as per the protocol. You will have study-specific procedures for reporting deviations. Deviations of a serious nature may be reported in an expedited manner and may need to go to the IRB (dosing errors, unblinding of study treatment, subject enrolled that did not satisfy entry criteria, etc.)
4. Compare source documents to Case Report Forms: You are checking that the data in the chart matches the Case Report Forms (which will be later entered into the clinical database and combined with other subject's data to complete the safety and efficacy analysis for the Investigational Product). Determine whether or not CRFS being completed in a timely manner. You also want to verify that the source is complete, neat (all corrections must be compliant with the regulations - white-out is not OK), attributable (who wrote it? Is it initialed and dated), contemporaneous (was it written at the time the procedure was completed?), valid (is the data collected even possible?), etc. Sometimes you will be asked to pull the case report forms and send them in to data management and other times they will stay at the site until the end of the study.
5. Review Investigational Product (IP): The study protocol will explain how the IP is to be stored, dispensed, and returned. Verify that all of this occurred properly by reviewing temperature logs, storage facilities, administration records, IVRS entries/reports for subject-specific IP accountability, and speaking to the relevant personnel.
6. Regulatory Binder / Essential Documents Review: Determine if any forms need to be updated or pulled for the Trial Master File (TMF). The TMF is meant to be an exact replica of all the documentation at the site. Specific information regarding the contents of the essential documents binder are covered in section 8 of the guidelines.
7. Confirm Site Adequacy / Site Status: Determine if there are new staff at the site or if staff have left. Can the site manage with current staff? Has the site or the lab moved? Confirm that there are adequate study supplies
8. Study-Specific Monitoring Tasks: Depending on the protocol, you may need to perform additional tasks such as shipping materials back to headquarters (for example lab specimens, xrays, etc.), calibrating or reviewing calibrations of equipment, site training, checking eDiary compliance, etc.
9. Review Ongoing or Pending Issues from Previous Visits: At some point during every visit work with the staff to resolve any items identified at previous visits as ongoing issues. Indicate in your report once these are resolved.
10. Review of findings with the site: Whether or not you find issues during your visit, keep the site staff posted on your progress and how things are going. Especially, if the Principal Investigator is not available during the visit, be sure to summarize everything accurately and completely in your follow-up letter.

Try to schedule your next (or next several) visits before you leave the site. After the visit, write your report and send the follow-up letter within a week or per your monitoring plan and refer to your company's SOPs. Always report significant compliance issues to your management, the sponsor, IRB, and QA as appropriate. Remember that you must document everything because of the adage, "if it isn't documented, it didn't happen". Please contact me if I can elaborate on anything or if you think I've left something important out.

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

• Introduction to Monitoring December 2007
• Meeting with the PI August 2011
• Close-Out Visits July 2008

What to Expect at a CRA Interview

I’m posting to let you know what kinds of questions you might expect to be asked during a CRA interview. Practice these in the shower, in front of the mirror, or with a friend so you are prepared!


Typical Questions
Here are general questions that you will likely be asked with tips for answering shown in italics:

• Tell me about yourself? Keep it short and hand them a copy of your resume to look at while you give the penny-tour of your background and experience. Showcase yourself, “I live in San Francisco and I have 5+ years experience in this industry. I have been working as a CRA for over 18 months. I have had the opportunity to work in Phase I, II, and III trials for the following indications… I attended courses for CRA training through a local university and I am an active ACRP member.” Be prepared to explain why you are currently job seeking and any gaps in your employment history or a trail of many past job over a short period of time.
• What are your salary requirements? I’ve had success with this script, “I will consider the entire package including employer flexibility, 401K, a competitive benefit package, etc. However, my minimum salary requirement is $$$$. I would be pleased by a compensation package that includes benefits and incentive compensation to increase the value. From my research, it appears that similar positions in this industry are paying between $$$$ to $$$$.” Then be quiet!!!
• What percentage/amount of time are you willing to travel? Be honest. Travel is difficult and it is not in yours or the employer’s best interest for you to misrepresent yourself when this question is asked.

So here are the more role-specific questions:

• Have you had GCP training or formal CRA training through an employer or accredited course?
• Do you have experience with the following?
  o Regulatory document review
  o Selecting and recruiting qualified and interested investigators
  o Performing source document verification
  o Utilizing EDC, electronic diaries, or IVRS systems
  o Database close
  o Development of protocols or ICF?
• Do you have experience with the following therapeutic areas: Cardiovascular, CNS, Oncology, Diabetes, HIV, etc.? If you are interviewing with a CRO this is especially important because they will need to market you internally and to clients. There is no sense in lying here because there is no substitute for experience. Try to highlight experiences you have from other jobs that better prepare you for a monitoring role. For example: “Although my oncology experience at this point has been limited to clinical database and CRF design, that experience has afforded me the opportunity to read through no fewer than 10 to 15 different oncology protocols from a variety of sponsors and assist (at least on the data end) in these sorts of trials. I have had the opportunity to develop some very fundamental and transferable skills in XYZ indication this past year related to study start-up, maintenance, building/maintaining relationships with study sites, trial fiscal management, and facilitating cross-functional trial specific working teams to track and deliver important study milestones on time/budget.”
• What is the greatest number of [protocols, sites, patients] that you have been responsible for at any one time?
• Which phases have you worked in?
• How many [pre-study qualification visits, site initiation visits, site monitoring visits, site close-out visits] have you conducted in your career?

Undoubtedly, the last question you will be asked is, "Do you have any questions for me or about our company?" And the answer is, Yes, you do! I know you will be nervous, but ask good questions and listen to the answers to the questions and try to get feedback during the interview so you know how you are doing.  You may have been misunderstood during the interview or missed an opportunity to really sell yourself.  Asking great questions will give you one last chance to show your best or address any concerns the interviewer has before you part or even in a follow-up letter or email.  Here are some generic ones, but you have to ask something:

• Describe the three top challenges that I'll face in this job?
• What are the key metrics for measuring success in this position?
• If I were offered the opportunity to work with your organization, what would you like me to accomplish in my first 90 days?
• How would you describe the qualities of the most successful people at your company?
• How closely do my qualifications match the requirements for the open position?

Interview Styles
At this point, I want to mention that there are various interview styles. Being familiar with how (and why) questions might be asked will only help make you more prepared when it is time to come up with the answers. I am going to discuss a few interview styles below. The person conducting the interview may stick to just one style or have a mix of several – this is especially true when you are in a panel interview. Then it feels like you are in a firing range but just stay calm and try to engage the panel so you aren’t doing all the talking. After all, this is your opportunity to interview them, too, right? Anyway, here are a few interview styles you might encounter:


Behavioral – Everyone knows that past behavior is a very good indicator of future performance. This interview style will require you to answer in a manner that shows you are creative and quick on your feet. Sometimes the right answer is not as important as the delivery. Before you answer think hard about why they are asking this particular question and try to cite examples of past behaviors that are relevant to the job you are applying for and explain at the end how the skills and experience you are describing would be transferable in your new role. If they ask you about a past mistake or you describe something you did but would now do differently, say so and explain why. Nobody is perfect so showing that you learn from past experiences can only help you in the interview.

• Tell me about a time when you showed your ability to [adapt to a new situation, solve a problem, etc.].
• Tell me about a time when you demonstrated [initiative, integrity, excellent communication, etc.].

Situational/Scenario – If you have no idea what the right answer is, you can try stalling, asking the interviewer for help, or just qualifying your response. For example, “Honestly, I am thinking of a few possible answers for the question. On the one hand, I feel like this might be the right response, but on the other hand, I can see a scenario where this might be the right approach. Which are you looking for?” or “Well, I must admit that I haven’t ever been faced with this particular situation, but I imagine I would handle it as follows….” Here are some examples of situational questions:

• You’re at a site and discover an unreported SAE, what would you do?
• You are performing a routine monitoring visit and discover that the site has enrolled a subject but forgot or improperly consented them, how would you handle this situation?

Assertive – I personally find this style offensive. Any employer that utilizes these tactics is likely not one that I am very interested in working for. After all, if they are a jerk in the interview, what is it going to be like on a daily basis or when it is time to sign your expense reports, or partner to work on your performance goals, etc. In any case, an assertive interviewer will treat you really nastily or act very cold/aloof to see if you will get nervous or flustered. I find brevity is key in these types of interviews and if there are long periods of silence, just sit calmly and pretend like you are unaffected. Be careful not to be too defensive – it is usually a trap to see if you can keep your cool under pressure. They might say something catty like:

• It sounds like you don’t have a lot of experience with [insert something rude here], what makes you think you can do this job?
• I have a lot of other more qualified candidates, why should I hire you?

Structured – This interview is basically just like a test and you need to pass to make it to the next round. It is a typical style for CROs (where many different people perform new candidate interviews but then need to assess all applicants against the same standards) or for first-round interviewers. Essentially, the interviewer is looking for a specific answer, and once you say the magic word or list the 3 bullets they are looking for, they will move on to the next question. It is fine to ask how you are doing if you are feeling nervous along the way – they will probably find it endearing rather than count that against you (they probably suffered through the same type of interview when they were hired).

• What are the critical components of an ICF document? Know your regulations and GCP guidelines – All of them – this one is CFR 21 Part 50.
• What are the activities that take place during an [initiation visit, close out visit, etc.]?

Conclusion

Every person you interact with may be
asked to provide input on your interview
performance.  Remember to always respect
"gate-keepers" like reception/administrative
staff and the HR person who arranged
the interview.

Here are a few other random tidbits of general interview advice:

• Show up on time, be well-dressed/groomed, and be nice to the receptionist.
• Fill out the employment application in advance. When you ask for this you are demonstrating your enthusiasm for the position and you are showing how organized and methodical you are when approaching new situations. If there is no application to be completed, at least bring your government issued ID and a list of references and old employers in case this is needed.
• Avoid sounding cocky, smug, or coming off as entitled.
• Assess how the interview is going by using any of these targeted questions after you provide an answer: “Did I give you enough detail?”, “Was I clear on that?”, or “Would you like me to elaborate?”
• Never ever ever lie about your experience! Our industry is a small one and your reputation will precede you. It is a huge risk so just avoid it. Besides, as CRAs our primary objective is to ensure the safety of subjects exposed to Investigational Product. As an extreme example, if you lack the experience to do something and say that you actually can, you may be given a position that you are not qualified for and as a consequence, subject safety could be jeopardized.
• Never say anything nasty about a previous co-worker or employer – it only makes you look bad.
• Watch for and avoid illegal questions – It is absolutely inappropriate (and in some cases against the employment laws) for the interviewer to ask you questions about your age, race, religion, marital status, and whether or not you have kids. If you choose to volunteer this information in the course of an interview, fine. However, if you are queried about any of the items above just say politely, “I’m sorry, I don’t feel comfortable with that question but would be happy to address any others you have.” or re-direct the questioning in some other tactful way.
• At the end of the interview thank them for their time, ask what the next steps are in the process, and ask for the job! I know it sounds silly, but 90% of applicants won’t ask for the job. You don’t need to be shy. You researched this company for weeks, you got all dressed up and took an entire day (or several) to come in and interview. You don’t need to dance around why you are there, “When can I start?”

Now you know what kinds of interview questions to expect but this is really putting the cart before the horse because we haven’t even scratched the surface of how to execute a sound job search. I will be posting in the future with more information that will make you better prepared for your new CRA role including: ‘Choosing the Right Company as Your New Employer’; ‘Networking’; ‘Doing Your Homework Before an Interview’; ‘Following up After the Interview’; and ‘Tips For Excelling in your First 90 Days of Employment’. Let me know if there are other topics that are of interest and I will be sure to address them in other future posts.

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

• How to Become a CRA January 2009
• You Might be a CRA if...December 2008
• What are your Weaknesses? June 2009
• Challenges to a New CRA May 2009

• Introduction to Monitoring December 2007
• Creating a CV November 2007
• New Hire Orientation November 2007

Pre-Study Visits and Site Initiation Visits

Depending on the company you work for and the Standard Operating Procedures (SOPs), you may be required to complete an in-person Pre-Study Visit (PSV) before an investigator is initiated to join a clinical trial. In some cases, you may even be able to perform this via telephone, web-conference, or it might be waived altogether (say, for example, an investigator your firm has collaborated with in the past 18 mos or so).

The objectives of a pre-study visit are to review the adequacy of the site, the training and experience of the study staff, the access to the right patient population, and the site's interest in the study. If the site isn't motivated or if they are already participating in studies that would compete for the patient pool, they may not be a good recruiter. It is expensive to start up a site, monitor them, and supply them with all the study materials and training. Ideally, you would only open sites that would perform well but in reality, there are always 'dud' sites in every study (Read my related post on Selecting Qualified Investigators). This is typically a 2-4 hour visit. After your visit, you will likely need to complete a report template or assessment and send a follow-up letter to thank the site for hosting you and inform them whether or not they have been chosen to participate in the study.

At an Investigator Meeting there may be
presentations and break out sessions
to answer questions and train study
staff with the skills required to properly
execute the protocol.

The initiation of a site can sometimes occur at an Investigator Meeting (IM) where all the potential investigators are brought together in (a typically quite fancy) hotel or other conference arena to receive group training on the new study. More often, however, this will actually take place - on-site. This is usually a 4-8 hour visit and you may be accompanied by a Project Leader, Medical Monitor, or even Data Management personnel just depending on the desire of the sponsor. Before your visit, you will coordinate a convenient time for the study site and confirm your visit with a letter informing them when you will arrive and what the objectives of the visit will be. It is important to physically be at the site so, as a monitor, you can visit the labs, pharmacies, and other areas where the research will be conducted to ensure they are adequate. For example, both labs and pharmacies should have restricted access and the site should know where it will store the Investigational Medicine/Product (IP) and this location should be locked. If the site will be storing blood or tissue samples, you will inspect their freezers and ensure that they maintain adequate temperature logs and have standardized sample handling protocols and training.

During your initiation visit you will probably spend a great deal of time training or reviewing the study protocol design and answering questions from the site personnel. You will also want the Principal Investigator (PI) to be available for specific parts of your presentation. Specifically, you will need to discuss the Investigator's Responsibilities as related to the regulations to ensure there is agreement and understanding (The investigator may choose to delegate some of his/her responsibilities but ultimately, they will be responsible for all actions and conduct of the study. Specific study related activities can only be delegated to those who posses adequate training and experience -- a secretary cannot perform a Physical Exam, etc.); You will explain publication policies and documentation responsibilities; You will inform the PI that you will need timely access to subject's records and the acceptable time frame for completing patient data case report forms (CRFs) and answering queries regarding the data). Document everything that is discussed so you can add it to your report and if there are any questions that are unresolved at the end of your visit, you can include resolution for those in your follow-up letter after the visit.

Email me if you have more specific questions. Now that our study is underway, next time I will discuss how and why we complete routine monitoring visits throughout the study conduct period.



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

• Selecting Qualified Investigators April 2010
• Routine Monitoring Visits March 2008
• Close-Out Visits July 2008

Introduction to Monitoring

I've been out on the road for the past few weeks assisting some other monitors to review patient's medical records and the data that has been collected for the clinical trial. It occurs to me, that it would be beneficial at this point to further describe to you the roles and expectations of a Clinical Research Associate (CRA).

In a pharmaceutical/biotech company, teams of scientists are working to discover new molecules, compounds, and foundations for new drugs. In addition, these same scientists sometimes work to re-formulate current drugs or apply them for new diseases and indications (all of this work is done in animal models before the human clinical trials can begin). It is at this point that monitors such as myself come into play. Once an experiment that involves humans is designed, monitors help the company choose qualified and interested physicians to carry out the study. These 'investigators' are reimbursed for their efforts to conduct the trial and a CRA may also help negotiate the budget and/or contract between the parties involved.

A CRA job is a traveling job. Sometimes we go to glamorous places but more often than not we are monitoring in hard to reach or otherwise obscure locations. 

Objectives when we visit the investigative site (Doctor office, hospital, research center, etc.) include: 1) perform pre-study tasks during a Pre-Study Visit (PSV), 2) kick-off the study with a Site Initiation Visit (SIV), 3) routinely check back with the site regarding subject enrollment, trial conduct, and data collection during one (or typically many!) Interim Site Monitoring Visits (MV), and finally 4) shut down the site after their participation has ended during a Close Out Visit (COV). Before and after each visit, there are a variety of tasks and communications that need to occur in regards to preparing for, scheduling, confirming, and then following up on items from previous visits. Read some of my other blog posts to learn more about Site Initiation Visits, Routine Monitoring Visits, and Close-Out Visits.

Also, between visits, a CRA needs to regularly contact the sites and perform site management activities such as answering questions regarding the study design, encouraging enrollment, sharing tips from other sites, and distributing study drug (Investigational Product, IP), and managing site supplies inventory levels (often you are assigned up to 10 different sites to manage but this really can vary depending on geography, how many patients/doctor sites are participating, how many monitors are on the study, how complex the trial is, and a variety of other factors).

I'll explain more regarding the key tasks at each visit in later articles. There are many Federal and International regulations that apply to human research to ensure that the studies are valid, reliable, and above all, that the rights of the participating subjects are protected and we'll also get into those soon.