Monitoring Visit Follow-Up Letters

send a confirmation letter prior to every monitoring visit

You’ll send a confirmation letter (or email if your SOPs allows it) prior to every monitoring visit, be it a pre-study qualification visit, a site initiation visit, routine monitoring visit, close-out visit, etc.  Then you’ll need to document your visit findings in a monitoring report.  Finally, you will send the principal investigator a follow-up letter summarizing the visit and discussing any critical findings or action items.

Create Your Monitoring Visit Follow-Up Letter

As a rule, I try to keep the follow-up letter to no more than two pages.  It is best practice to have the letter completed, reviewed, and sent within 7 days of the visit.  I write the letter to the Principal Investigator (PI) but Cc in the coordinator and trial TMF and/or the regulatory person, my Lead CRA or Project Manager, etc. as appropriate per my SOP.

monitoring letter
your Lead CRA or the Sponsor may want
to approve the letter or provide a study-specific
template so check with your Lead before you send it

I dedicate the first sentence to listing the personnel who were present at the visit and thanking the study staff for their time and attention during the visit.  Be sure to include the dates of the visit as the letter will be filed in the Site Master File and the dates should match the Monitoring Visit sign-in log dates.  This is a good point to discuss any staff changes or recommended re-training.  Next I typically document the progress of study enrollment and then proceed to summarize the status of the Site Master File review, source data verification, and Case Report Form completion.

A Summary, Not a Novel

I break up the content where possible by using in-text tables or bulleted lists to note the following items as appropriate per the trial monitoring plan and SOP:

  • Informed Consent tracking details
  • Summary of patients/Case Report Forms reviewed
  • Site Master File or Source Documentation deficiencies/inconsistencies or Safety Findings
  • Protocol Deviations or Critical Findings (and appropriate recommended corrective actions as discussed with my regulatory contact, PM, or Lead CRA)
  • Supply Issues: lab kits, Investigational Medicinal Product, source documents, etc.
  • Action Items: resolved since last visit, new pending and wherever possible

No Surprises

My most important tip for follow-up letters is, “no surprises”.  During your time on-site you should be meeting with the PI and discussing the status and progress of the visit.  You should be summarizing your findings and discussing any issues so they can assist you to resolve everything while you are on-site.  If there are deviations or safety issues that need to be reported to the IRB, you can remind the Investigator of their responsibility to do so.  You can also provide re-training on the protocol or study procedures during your meeting on-site.

The Follow-Up letter should be
a recap of your discussion, not a news flash
.

In regards to action items, it is best practice to resolve everything before you leave the site to the extent possible.  I have extended monitoring visits to an additional day with approval from my Lead when there were items I would be able to complete with an extra half a day or so rather than leave pending.

If you are unable to meet with the PI during the visit, document this in your follow up letter and include a reminder that you are available by phone to speak with the PI.

Follow-Up Letter Template

I’m not planning to post a template.  Please don’t email me for a template as you can easily make your own using the guidance from this post that is study-specific for your trial’s needs.

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About 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 leadcra@clinopstoolkit.com anytime.

4 thoughts on “Monitoring Visit Follow-Up Letters

  1. Marten

    Are there really companies that won’t allow you to send the follow up letter by email? After 4 years working with several companies I’ve never experienced that. Maybe it’s because I’m working in Europe?

    Reply
  2. The Lead CRAThe Lead CRA

    Hi Marten, I’ve worked for several companies where we sent physical letters on company-furnished letterhead. I’ve also worked for one sponsor who didn’t require confirmation letters (only emails!). I believe that the letter is just an artifact to demonstrate the clinical record and show someone years later what happened in managing and overseeing the trial; whether it is paper or an electronic equivalent is completely arbitrary to me. I just want to be able to reconstruct what happened and the letter is a piece of that story and evidence.

    My current company requires all investigators to sign and date each followup letter. At the subsequent visit the monitor confirms that the signature (indicating a review of the letter) is documented in the monitoring report. Are any of you working on trials with this requirement in the monitoring plan?

    Reply
  3. Kelly Gagnier

    Hi Nadia,
    FOr our company it is good practice to have the investigator review and sign the monitor follow up letter as it shows good investigator oversight. We are not required to document this completion in our Monitor Reports though. I have had many audits and inspections where the auditors are quite impressed to see investigator reviews on everything and not only lab reports, ECG reports, source documents (monitor letters, DILs, newsletters, memos, etc).

    Reply
    • The Lead CRAThe Lead CRA

      Kelly, I’m glad to hear you have adopted this best practice. Anything we can do to produce additional documentation and proof of increased oversight can be a a plus in this highly regulated industry. Thanks for your thoughts on the topic.

      Reply

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