Monitoring Tools and 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
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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
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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. |
Don’t write things down twice, try carbon paper! |
Subject-Specific Monitoring Worksheet
- 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?
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Base your Excel template on the study Schedule of Assessments |
What’s in Your Bag?
- 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
3 Comments
Siobhan
May 1, 2013I am using very little paper these days. My monitor notes are done on my computer. I love my medical calculator on my iPhone.
Two tools that I use are a scanner (either Neat or smart phone) in PDF for collecting copies of reg. docs. This is really efficient for a COV especially if you have eTMF. It is also handy if you are allowed to scan your receipts for your travel expense report.
I carry a small surge protector with 4 electrical ports and 2 USB ports. This thing has saved me so many times when I have a co-monitor and there aren’t enough outlets.
Technology is great when it works. to prevent a disaster, I always back-up my computer before I travel. I travel with a flash drive and I back-up any new information I store on my computer to the flash drive.
Sofia
March 7, 2013Thank you for sharing your tools and experiences. As the technology evolves (eCRFs) I can really appreciate how others adapt, increase efficiency and pack as lightly as possible!
Stephan White
March 2, 2013These tools could be especially handy for resuming monitoring across multiple IMVs. These are some of my standard and favorite monitor tools.
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