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Thursday, March 24, 2011

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.

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