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

Motivating your Study Coordinators

As monitors, we rely on the Study Coordinators (SC) to assist us in site management activities like record-keeping and re-supply.  We ask them to keep us informed of progress at the study site through reporting, screening/enrollment logs, issue identification, etc.  We have them prepare the CRFs, complete data-entry, attend trainings, review newsletters/correspondence/memos, answer emails, fax in documents, and answer queries.  On top of everything else, we insist that they organize and prepare for our monitoring visits.  During the monitoring visits, we request that they are available to resolve any issues that are identified or to complete additional training.  This ongoing administrative burden during study conduct is all in addition to the primary requirements that they assist the Principal Investigator in executing the study according to the protocol and monitor the safety of all study participants.

In short, we ask a lot.  Many coordinators have several studies competing for their time and attention and one of the most important skills for a CRA is to motivate the SC to focus and respond to the demands of the trial at hand.  For the most part, my coordinators are prepared for my visits; I owe that to a mix of luck, experience, and the following techniques:

Establish and Maintain Rapport - Whether you meet your coordinator for the first time at an Investigator's Meeting or a pre-study or initiation visit, every interaction is a chance to build the relationship.  Answer your voicemails and emails promptly and invite your coordinators to reach out to you with their concerns. If you can listen and empathize, your coordinator will trust you more and keep you informed if they are falling behind.  If your coordinator feels respected and valued they will put in the time to get the work done properly.

Communicate the Timelines and Study Status - Share the study progress through regular site contacts or a newsletter and ensure that study staff know the timelines and overall picture of the trial.  Review site performance regularly and let coordinators and investigators know how they are doing compared to other sites.  You can set goals and make comparisons in terms of recruitment, enrollment, data entry/query resolution, and monitoring completion; sites find this extremely motivating if you can deliver the message and metrics in a non-confrontational way.  SCs are juggling so many competing priorities that they may not be working on something you need just because they don't realize it is "on fire" at the moment, that is way regular site contact and effective communication is so important.

Recognize Good Performance - When your site completes a required task or important milestone let them know you appreciate this and thank them for their contributions. I am constantly complimenting my sites; they are not perfect but they do lots of things well and I think they deserve that recognition.  I produce a monthly newsletter and I try to include a regular "Site Profile" section where I introduce the site, highlight their study accomplishments, and discuss their tips for success. It is a bit corny but my sites are always flattered and this seems to produce great results.

Don't be afraid to submit to bribery.

Understand and adhere to your company's

policy on gifts. Typically a non-material

small appropriate token such as a box of

donuts or pastries will do a lot to "butter-up"

and endear you to your coordinator

without the risk of appearing coercive.

Partner with your Coordinator - Convince your coordinator that you are a team and that you want them to be successful, "I know you have a lot on your plate, so let's get through this so I can get out of your hair."  Ask your coordinator, "What are the obstacles preventing you from getting your work done? Would you find it helpful if the sponsor, the Project Leader, or I spoke to the PI?"


Break out the Big Guns - All of the techniques I mentioned above will keep your study sites on track and foster a productive and collaborative working relationship.  At the end of the day however, if the work just isn't getting done you may explore alternative less positive methods of motivation.  Expose the deficiencies to the Principal Investigator or withhold site payments pending completion of the work.


Above All, Be Patient - See a related post where I discuss how issues outside of work can sometimes distract coordinators: What is up with this coordinator?

Please comment to let me know if there are other tips or techniques I should highlight in regards to motivating study coordinators.

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

• Tips for Better Monitoring Visits March 2012
• What is up with this coordinator? November 2010
• Routine Monitoring Visits March 2008

Little Wrap Dress

One of my co-workers commented
the other day that I really own a
lot of dresses.  OK, that is true but
it hasn't stopped me from adding
this little beauty to my birthday wishlist!

My go-to garment in my work wardrobe is the wrap dress (recommended only for the ladies, sorry guys!).  The wrap dress is perfect for travel because it is easy to accessorize (scarf or long beaded necklaces or chains) takes up next to no space in my suitcase (read here about what I pack for a monitoring trip) and looks professional when paired with a cardigan sweater, pashmina, or blazer.  Also, I pay attention to fabrics and always go for a dress that is wrinkle resistant so I don't waste time ironing or money cleaning (think polyester, spandex, matte jersey, etc. - not totally luxurious but ideal for balling up in a suitcase and typically machine washable or can be hand-washed rather than going to the dry cleaner).  Spring is coming and these don't take up much room in my closet either so I can usually sneak in a new one every now and then without my fiancée noticing. ;)

I do like to pack a wrap dress for multi-day trips but I typically save it for day 2 or the midpoint of the visit. I make other choices on travel days because a dress is really not ideal for going through airport security; I don't want to take off my shoes and walk around barefoot there and I am a bit more restricted and limited in reaching or bending.  Gee and I would not be thrilled to receive a secondary pat-down/feel-up in one of my beloved wrap dresses (I refuse to go through back scanner x-ray machines).  Also, I might get a little cold on the airplane so I prefer long sleeves and slacks.  Other than that, I really feel this is must-have smart attire for all the young female monitors since it is forgiving enough to flatter most body types.  Ladies (again, sorry Gents, this post is just not for you), if you haven't rotated one of these pieces into your wardrobe I recommend you give it a try.


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

• Beauty Break April 2011
• Challenges to a New CRA May 2009
• Efficiency Tips for Expense Reports August 2008