The Lead CRA Blog: February 2013

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.

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