Efficiency Tips: Spend less time on Monitoring Visit Reports

Many Protocol and Many Monitoring Visit Reports

Draft Monitoring Visit Reports before you even arrive on site

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.

Fill in any particulars you can for your monitoring visit report

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.

Be organized before you arrive

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.

Monitoring Visit Report notes can go right into the template

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.

Utilize your travel downtime to be productive

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?

Airport Lounge Access
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.
About The Author

The Lead CRA

Nadia started The Lead CRA blog in 2007. She is now lead author for ClinOps Toolkit. Nadia is currently working as a Clinical Program Manager at a small specialty pharmaceutical company in the San Francisco Bay Area. You can reach Nadia via email at [email protected] anytime.

5 Comments

  • Sary

    September 30, 2013

    Hi Nadia,
    Just sometimes I have problems in using words and grammar while writing monitoring visit reports. I am told that in report, I should avoid pronouns like I, we, …or future tense. In action items If I want to mention in future I will say “Investigator to report xxx to IRB on DD/MMM/YYYY”.
    Do you have any recommendation for this?
    Thank you in advance,

    • Nadia

      The Lead CRA

      October 3, 2013

      Hi Sary, my best recommendation is to recycle, recycle, recycle. Obviously you need to tailor each individual monitoring report to reflect the accurate summary of the visit. As you receive feedback from your lead on your reports, incorporate that feedback into new reports pro-actively. One of the best ways to do this is to actually copy and paste the language or statements that are being received positively by your team. Sometimes when I am writing a report in word or the Clinical Trial Management System (CTMS), I can copy and paste the typical language I use when discussing a topic or answering a particular item. There is no need to start every report from scratch but remember that if you do copy and paste at all from other sources, then make sure that everything flows well, is grammatically correct, and accurately reflective of the visit.

  • The Lead CRA

    The Lead CRA

    February 21, 2011

    Hi Rakhi, when writing reports you want to capture a synopsis of how you spent your time and what you achieved during the visit. For a summary of objectives please check out my post on Interim Monitoring Visits.

  • rakhi

    September 16, 2008

    Hi this is ramakrishna CRA,
    i need information on how to write reports to sponsors and investigators.

  • rakhi

    September 16, 2008

    its very nice and useful to every CRA. thank q

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