Benjamin Franklin famously stated, “If you fail to plan, you are planning to fail.” It’s a simple statement with complex undertones, because who among us wants to fail intentionally? Yet, we all fail to plan more often than we would like to admit.
The reason failing to plan is so detrimental is that it leaves us vulnerable to the floundering whims of the day. Instead of moving in a beeline towards our goals, we wind up haphazardly dabbling in multiple undertakings – which are all frantically competing for one’s attention. Clinical research monitors understand this dilemma as well as anyone. And that’s why planning and resourcefulness are arguably two of the most important skills honed by them.
It’s these abilities that enable monitors to be time-efficient, while also ensuring patient safety and clean data submission. Therefore, in an effort to help clinical research monitors become more resourceful, here are a few planning tips to help save time when conducting routine monitoring visits.
Preparing for a Visit:
- Review all relevant vendor websites and the prior trip report. By reviewing vendor websites (i.e. EDC, IP, Labs, etc.) you can get a clearer understanding for what to address while onsite. Looking over the prior trip report will show you what action items remain outstanding and whether or not there are specific site staff and/or site locations that you may need to meet with and verify, according to the requirements listed in the Clinical Operations Plan/Clinical Monitoring Plan.
- Review the most recent correspondence. This includes communication directly with the site staff and/or the study team. Reviewing items like the latest study newsletter can give you an idea as to areas that may be of concern (i.e. study-wide incorrect data entry trends, etc.). It is also a good idea to take a copy (electronic or paper) of the latest study team communication with the site. This might come in handy when you are unable to locate documents during review of the Investigator Site File.
- If at all possible, send a confirmation letter to the site that contains a visit agenda. This will provide the site staff a sneak peek into what you will be looking to focus on during the visit. They will be able to better prepare if they know what it is that you will need to review and address while onsite.
- Prioritize tasks while staying flexible. As important as it is to plan, it is equally important to stay flexible. You never know what a monitoring visit will truly require until you arrive. Plan for what is required, but stay open to the possibility that you may have to re-prioritize once onsite.
Create a to-do list that identifies the tasks you cannot skip during the visit. This will improve your rate of productivity – even if there are numerous proverbial fires to extinguish.
- Remember, productivity rate = the amount of output in any given hour of work
Time-Saving Techniques While Onsite:
- Type all visit notes within your report. If your study uses a Clinical Trial Management System (CTMS), like Trials360, you can answer report questions and jot down anything requiring follow-up directly into the system. This will prevent you from forgetting key issues and force you to be as accurate as possible, keeping in line with what took place during the visit.
Saving notes directly into the report also ensures that you have answered all the requisite questions for your visit.
- Schedule the next 2-3 monitoring visits while onsite. When you are onsite, you have the undivided attention of the Study Coordinator (SC) and can often get first dibs on prime visit dates (think holiday season!) while ensuring you stay within the study visit window. Even though these future dates will be tentative, by scheduling while still onsite you will reduce the amount of time it would have taken you. And you will avoid playing phone/email tag with an SC in an attempt to find a date and time that works for all parties.
- TAKE BREAKS!!! We don’t know what it is about the monitor role, or the people drawn to it, but it is common for monitors to either take a working lunch or skip lunch altogether. Please do not fall into this routine. This tip is for both the newbie and the seasoned monitor. Plan to take breaks!
There’s the adage that “time is money,” but your health and wellbeing are priceless. Give your eyes and your brain a break, stretch your legs and refuel your body. Skipping breaks is the fastest way to reach burnout as well as to make easily avoidable mistakes. When working in clinical research, mistakes leave human lives hanging in the balance and may require lengthy resolutions that could have been avoided.
- If at all possible, escalate issues and meet with the Principal Investigator (PI) prior to the very end of your visit. Escalating major issues to your upline, as you become aware of them, puts you in a prime spot to get any further information they require prior to visit completion. It also allows you to have the opportunity to address the issue(s) with the site staff before it appears in a Follow-Up Letter (the post-visit letter should never be the first time the site staff learns of an issue noted while you were onsite).
If you meet with the PI before you race off to the airport, there is also a chance that you might resolve some of the action items from your current visit. This will help save you time on the back end of your visit, which is invaluable. As monitors often have the most administrative work to do, with the least amount of time to get it done in.
Motivational speaker Brian Tracy tells his audiences that, “every minute you spend in planning saves 10 minutes in execution; this gives you a 1,000 percent return on energy!” Taking the time to plan can reduce the amount of time needed onsite, and will help you to better manage your limited time while there and afterwards.
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