Monitoring Tools & Notes

As a regional monitor, I have primarily worked on studies with a conduct period of only a few months.  For these trials, I can typically monitor an entire subject’s source in just a couple of monitoring visits (IMVs).  However, I do use a few monitoring tools to keep me organized and assist with report completion.  I obtained most of these templates and advice from other talented CRAs I've been lucky enough to co-monitor with; special thanks to all my wonderful resources who have been open to sharing tips and tricks along the way.  For studies that last longer than a few months, these tools could be especially handy for resuming monitoring across multiple IMVs.    These are some of my standard and favorite monitor tools:

Generic Calculators & References

Never leave home without a date wheel!

• Height/Weight/temperature conversion
• A date wheel for calculating the # of days between visits (checking for out-of-window deviations)
• Nurse’s Pocket Drug Guide book
• Medical Dictionary
• Websites: webmd.com or drugs.com

Study Specific-Calculators & References

• Visit Window Excel Calculator
• Drug Compliance Excel Calculator (if you aren't an Excel guru then ask your Lead CRA or one of the Data Managers to help you out)
• Pocket-Sized Protocol (If you have a PDF or word version of the protocol any copy shop can produce a little spiral bound or gum-bound booklet for you for around $30-$50....worth every penny and you can probably pass it through an expense report - check with your PM)
• Study-specific CRF Completion Guidelines
• Essential Document Tracker and TMF Submission Form
• Recent Correspondence, Study Newsletters, etc. (nice to have printed on hand so if there is a gap in the Site Master File I can just I can just leave a copy behind at site)
• Blank Study Forms 
• Mocked-Up Study Forms (I have worked on several psychiatric studies that utilized SCID, MINI, or a similar scale/questionnaire to screen for exclusionary criteria.  Since the questionnaires can be so long and involved, having a properly (or prohibited) completed form to compare to the source can be a huge time saver and serve as a checklist. 

Monitoring Report Template and Follow-up letters & Action Item Logs

The most important thing you can bring to every visit is a blank copy of the monitoring report, in my opinion.  Your goal should be to complete as much of the monitoring report as possible while on-site.  If you take your monitoring notes in the report template, you have less paper to keep up with and this will really increase the quality of reports.  The longer you wait to write a report following the visit, the lower the quality -- document your findings while they are fresh.  A monitoring report template also serves as a great checklist to ensure that you don’t forget to do all the routine tasks (like sign the monitoring log, check the temperature records, etc.)

IMV Specific Monitoring Notes & Stickies

If you use a monitoring notes log,
consider producing the log on colored paper or NCR
so it is easier to keep track of in a pile of documents.

Post-it Notes stickies are great for flagging discrepancies and other items that need attention in source documents (blank fields, missing signatures, headers incomplete, etc.) but these can fall off or the coordinator may remove them once complete so that makes going back to verify they have been addressed difficult (I usually flag on the top and ask coordinators to move the sticky to the side to indicate it has been addressed rather than remove it).  I like to number my stickies and/or add little notes to them.  Then I can track the stickies in a subject-specific log like the example here.  

Some CROs and companies discourage the use of formal monitoring notes and stickies (as they can potentially lead to avoidable audit findings if left behind in a source binder) so do check with your Lead CRA to make sure using these types of tools is permitted.  

Don't write things down twice, try carbon paper!

I review my monitoring findings with the Study Coordinator or PI at multiple check-in points during the visit and sometimes they like to take monitoring note sheets with them back to their desk to work on the items while I am there.  If we aren’t able to resolve everything while I am on-site I photocopy the monitoring worksheet so I can write up the action items in my report and review that everything was addressed at my next visit. 

I have also made my monitoring notes on NCR carbon paper before and this has been extremely handy for me in order to leave a copy for the coordinator.  You can have your monitoring note worksheets pre-printed on carbon paper at any copy shop or you can buy the paper yourself to use in your own printer or to fill out by hand.  Also consider just bringing along a perforated carbon paper lab notebook or tablet if you anticipate leaving lots of to-do items behind.

Subject-Specific Monitoring Worksheet 

So again, my goal is always to write as few notes as possible while on-site.  I try to just document everything directly in the monitoring report template, follow-up letter template, and Clinical Trial Management System (CTMS).  That said, it can be useful to have some subject-specific notes when pouring over lots of medical records or extensive source documents.  Your subject-specific monitoring notes worksheet can also be a helpful reference at future visits or when completing authoring a report once you leave the site.  If you develop a little study-specific template, you can easily track out-of-range lab values across visits, ensure that all required protocol tests and procedures were completed, more easily fill out site payment or CTMS trackers, monitor consistently and more efficiently, etc.

Aim to only track things that wouldn't necessarily be recorded in the CRF or monitoring report but could potentially adversely impact subject safety or data integrity.  For example:

•  If lab values are abnormal at a visit, how long do they take to return to normal? Are the AEs recorded properly?
• If AEs are occurring, are new Concomitant Medications being added? Is the dosing of Investigational Product being adjusted?
• Who is completing each assessment (same person each visit?)
• Are all study drug kits being returned at every visit?
• Are there out-of-window visits or other compliance issues?

Base your Excel template on the study Schedule of Assessments

I also try to limit myself to a single page of notes per subject, front and back permitted.  I typically take the notes in Excel so I can copy and paste them into my report but if you prefer to have a printed template, consider the colored paper trick and use something durable like cardstock so you don't inadvertently lose your treasured notes in a paper shuffle.

What's in Your Bag?

So what other tools and templates do you find useful when monitoring?  Leave me a comment here, send me an email, or share your monitoring tips on my Facebook page.  

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

• Tips for Better Monitoring Visits March 2012
• Sponsor Furnished Source Documents  April 2011
• What to Pack for a monitoring Visit August 2008
• Routine Monitoring Visits March 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 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