Monitoring Visit Follow-Up Letters

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

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.

You may also like...from The Lead CRA archives:

• Meeting with the PI August 2011
• Routine Monitoring Visits March 2008
• Close-Out Visits July 2008

Efficiency Tips: Keep the Inbox and Sent Box Empty....and Archive Emails Weekly

This is my Outlook folder list. I try to 

keep the inbox at less than 20 items at 

all times.

Today is Wednesday. I have received/sent and processed over 300 emails. Other Clinical Operations people in my immediate working group see even more traffic in their inbox but I can conservatively say that around 120 emails per day is my typical average. A few folks in my department file nothing and just rely on the blackberry and Outlook search functions to run their email empire. However, I feel pretty panicky if my inbox goes over about 20 messages or so. I use my inbox as my tasklist and I rely on folders and flags to keep everything organized. I've developed a system over the years to keep my inbox slim and zen-like and today I'm going to describe it to you. I also try to review and file items in my Sent box at the conclusion of every day because I prefer to file email responses with the original thread and keep my Sent box empty (Outlook can do this automatically for any message sent from any folder rather than the inbox.  In Tools->Options->Advanced Email Options-> you can select "Save replies with original message").

The batch process approach to filing TMF correspondence
Most site managers I know wait until they are preparing to close out an investigative study site then they go back and read several years worth of emails, print out the ones they think should be filed (2 copies, one for the TMF and one for the site), carry the big bound stack with them to the site, and slip it in to complete the correspondence file. An issue with this approach is that it wastes a ton of time and paper plus you are almost assured to introduce duplicates since the coordinator has likely done something similar. Finally, you are assuming that A) you have time for this exercise at the end of the trial and B) that you will still be around/employed to execute this action. Sorry to be such a realist, but both A and B are not exactly solid suppositions. My approach is to file my emails weekly in the eTMF.  As a result, at the end of every week, I am confident that 90% of my TMF correspondence is filed. I am never more than two weeks behind.

Keeping the inbox empty (or nearly empty...)
I strive to process every email within an hour of receipt. When something hits my inbox I 1) delete it 2) respond to it quickly (and delete it or archive it) or 3) file it. Deleting an email straight away will save you time from re-reading it again; dump it! If the email doesn’t require action from me and I am not waiting on a response, I can just file that email or delete it. I have a folder for my manager/HR/corporate stuff and travel. I have a folder called Praise where I keep thank you notes and email records of major deliverables or accomplishments (this is useful at review time or when I need a pick me up after a defeating day/week). I have a folder for each study I work on. I have a folder for all sites in a study. I have a few folders to keep vendor communications. I have a folder called #Pending (the pound makes it sort to the top of my folder list) for anything with action indicated from me and that takes more than 2-3 minutes to address. I have a folder called #Waiting for things other people are tasked with but that I want to track or follow-up on. I have a folder called #File for items that may be candidates for the TMF correspondence section (no, I don’t file every email in the TMF).

You actually have to Process #Pending #Waiting #File & Sent
I deal with everything in #Pending (at least the items flagged Overdue, Today, and Tomorrow) in the mornings when I arrive at work and in the afternoon when I am wrapping up for the day.

I use flags (Today, Tomorrow, This Week, Next Week) and group by flag to keep #Pending manageable.

At the end of every day (or when I have a few minutes during the day) I go to my Sent folder and I group by conversation trail or category, delete most of the thread, and move the final message to #Pending, #Waiting, #File or one of my folders. Archived in a folder = no action indicated; never to be referenced again except possibly in a future search.

I go through #Waiting at least once a week. When something in #Waiting is addressed by an incoming email message I delete the item from #Waiting or archive it in a folder.

I process #File on Fridays or anytime the folder shows that it contains more than 50 items. I group it by category or stack it by subject line or conversation. I delete everything leading up to the final thread. I typically have about 15-20 actual emails to file each week and I copy those to our TMF. I can just drag and drop from Outlook into our Clinical Trial Management System.

Outlook Features Help Me Stay Organized
I use Outlook quick steps and rules to quickly file things and/or label/categorize (if an email goes to a certain person or has a certain site name referenced in the subject then it gets a label/category automagically for that site). I use Categorize extensively (newsletter, meeting minutes, issue, login credentials, one for every PI name, specific vendor, TMF, reference, reference doc, expense report, personal). I also use search folders, too (mail received this week, mail received this month, with attachments, logins, newsletter ideas, reference, reference docs, amendment items, mail to/from specific people).

Correspondence Reconciled. Easy.
Now that you are so organized, you can actually use correspondence to prepare for your visits and write your monitoring reports. A few days before every visit, I go to the Clinical Trial Management System eTMF, select all the correspondence since my previous monitoring visit and print it to one big PDF. I open that document when I am at the site and thumb through the correspondence that has been filed by the coordinator since my last visit (the coordinator always files new stuff in front of a colored piece of paper). If the coordinator has already filed the item I delete the page from my PDF. When I am all done I email the PDF to the coordinator (remember, the only pages left are the ones the coordinator did not have filed) and ask them to print it and we file it before I leave the site.

Conclusion
I know this all sounds really intense but the system works for me and I have inspired several colleagues to adopt the system (at least in part). Try a #Pending #Waiting of #File folder. You might find that you have a useable and less intimidating inbox moving forward. Be warned however, the whole system falls apart though if you aren’t disciplined about reviewing your new #Pending #Waiting #File and Sent boxes at regular intervals. Please share any email efficiency tips or tricks that you find helpful.

Efficiency Tips: Tackle the Correspondence Tab

Group and Organize the Paper Monster

That behemoth regulatory binder binder could definitely be less daunting. Section it out logically by slipping a colored piece of paper or a tab in to demarcate each quarter.

Replace the binder

A new binder is less than $5. If the rings are damaged and every time you flip a page entire chunks fall out or the holes get torn, stop fighting it and replace it.  Many of my sites have switched to a plastic bin system and use a hanging folder for each traditional tab. Finally, I can leave my three hole punch at home and making copies for the TMF is now a breeze. Sometimes I just put little colored stickies on the pages I want and I ask the coordinator to fax or scan them to me. When I get back to my office they are waiting in my mailbox and I just ferry them right over to the TMF room.

Hanging file folders during conduct are a brilliant way to organize the SMF.

Don't Put it Off Until the "Next Visit"

Review the correspondence tab at every visit but don't reconcile the old stuff again until the end of the trial at close-out. How do you do this? Just bring a colored piece of paper with you to the site and write “Everything behind this {color} paper was reconciled against the TMF during the monitoring visit on {date}. Attn: Study Coordinator, please file any new correspondence in front of this paper and I will review and file at the next monitoring visit. Thanks! {your name}”. File it at the top of the correspondence pile so the coordinator sees it when they open the binder.  Simple, elegant, and it works. Try it!

Other tips?

Every Email is an Essential Document...or perhaps not

Wait, you said I shouldn't file every email?

Please, no, for the love of all that is Holy, don't file every email. I currently manage 15 sites and as a general rule, only about 1 in 10 emails I generate end up in the correspondence tab. This is because I do a lot of back-and-forth emailing with my sites. I never file the first email, just the final thread with the conversation trail included, assuming it is worth filing.

Image courtesy of rmgimages.

Items that are worth filing reference clarifications, demonstrate training and oversight, address GCP issues, discuss protocol deviations, and document conversations involving the Medical Monitor. I have trained all my coordinators on this and when I go to monitor the correspondence tab is nice, slim, tidy, relevant, and useful.

Emails that probably do not need to be filed:

• “Happy Birthday to your administrative assistant!”
• “Ordering pizza, do you prefer veg or meat?”
• “Have a nice weekend!”
• If I am sending my site PK tubes and I email them tracking information, then they write back to say they received the tubes, then I look in the lab database and see that indeed, they did complete the required PK draws, this conversation really does not need to be filed.

Site Master File: Correspondence

The Site Master File (SMF) or Regulatory Binder contains all of the essential documents to provide a record of study conduct. The SMF when reviewed with the clinical charts and archived study materials allows sponsors, auditors, regulators, and all other interested parties to reflect back on a clinical trial and understand how things were conducted, when, and by whom. The Regulatory Binder is created at the beginning of a study, updated as needed throughout, reconciled with the sponsor's Trial Master File (TMF) along the way during routine monitoring visits, and then archived at the end of the study.

The SMF is usually a big chunky (broken) three ring binder (or series of many binders) stuffed to the gills, bulging at the seams, and typically just a little bit intimidating.

Most sponsors maintain documents electronically but our industry is very much still a world of paper and at a site level, most study documentation is physical original or copied papers. For a list of the required items in a regulatory binder for a US trial please refer to ICH E6 Guidance Document on Good Clinical Practice (E6), Section 8 “Essential Documents for the Conduct of a Clinical Trial.” (protocol, Investigator's Brochure, trial logs, lab documentation, IP documents, correspondence, etc.).

Today I am going to review the Correspondence section of the SMF and in a separate post provide some tips for monitoring this item. As a general rule, monitors do not enjoy reviewing the SMF; I would propose that the Correspondence section is one of the most detested sections and often skipped. I have seen correspondence that spans multiple volumes for longer trials and have personally lived the nightmare of organizing these on more occasions than I can count. Some people insist on filing every little stitch of paper but I encourage you to review the regulations, your company SOPs, and to file sparingly. Only file items that truly support the record of conduct and that tell the story of what happened, when, and by whom.

What needs to be filed in Correspondence?

Important emails/threads (As I discuss in a different post – not every email!), Note to File (sponsor/vendor generated), Official study memos, newsletters, Investigator Recruitment Plans, etc.

If found in Correspondence, File Elsewhere:

• Monitoring Visit Confirmation and Follow-Up letters (file these with the monitoring log or in their own tab for ease in reconciliation)
• Budget/Contract, generally anything with $$$ listed
• Duplicates (just shred the copy)
• Audit reports
• Training Files, agendas, and slide decks
• IND Safety Reports
• Investigational Product Documentation (packing lists, confirmation of receipt, destruction or return documents)
• Packing slips (study supplies, lab supplies, etc.)
• Subject identifying information (check-stubs for study participants, copies of IDs, medical records that have not been de-identified, etc.)
• Notes to File (site generated) If subject-specific file with the chart, If more global in nature, just give them their own tab (ensure copies are retrieved and submitted to the TMF)

How should correspondence be organized?

Please file correspondence in reverse chronological order; old stuff at the back, new stuff on top, sorted by date.

You may also like...from The Lead CRA archives:

• Efficiency Tips for Tackling the Correspondence Tab March 2011
• Routine Monitoring Visits March 2008
• Email Management April 2011