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.
|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
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.