All content copyright, Creative Commons Attribution-Noncommercial-Share Alike 3.0
Unported, with the attribution: "The Lead CRA Blog", and a link to the post.

Showing posts with label correspondence. Show all posts
Showing posts with label correspondence. Show all posts

Monday, April 16, 2012

Site Startup Series

Welcome to The Lead CRA Blog Site Startup Series.  This course of blog posts is designed to step you through the various activities of launching a clinical trial site.


What are the regulatory requirements before recruitment can begin? What are typical sponsor requirements? How do clinical trial sites even get chosen? These topics and more, demystified in the series below:
  • What are the typical milestones of site startup?
  • Metrics, trackers, reports, and dashboards
  • What is feasibility? How do sponsors choose which clinical trial sites they work with?
  • What is an essential document package and a regulatory submission?
  • Informed Consent Form templates
  • Why do contracts take so long? How are they complicated?
  • Site Budgets
  • IRB submissions
  • Calculating Investigational Product needs
  • Providing study supplies and source documents
  • Ensuring sites are adequately trained and prepared to participate
  • Developing Investigative Site Patient Recruitment Plans
  • What correspondence goes in the Trial Master File?
  • Gating tasks...bottlenecks
  • Lessons learned, where did the process breakdown?
  • How to speed up site startup?
Are there other questions or topics that you would like me to cover related to site startup? Please leave me a comment or drop me an email at leadcra-mail@yahoo.com.

Sunday, April 15, 2012

Thinking About Site Startup

I've been thinking a lot lately about how important it is to choose the right clinical trial sites for the success of your trial.  Just last week I blogged about the painful process and high costs of closing non-performing or under-performing sites.  I recently told a non-industry friend that it can take upwards of 18 months sometimes to usher a clinical site from selection to initiation.  He responded, "well that make sense since many clinical trials last several years and it takes a while to give the medication to enough patients to test it out thoroughly."  Then I realized he had misunderstood me, I clarified, "Initiation means the doors are open. At initiation, a doctor can start looking for patients.  I am telling you that it can take one year or more sometimes just to get a site open for recruitment to start the trial."  He was floored and responded, "no wonder we're paying so much for our prescriptions..."

I recently went to an ACRP seminar called 'Why Sites Fail in Study Startup'.  The dynamic speaker, Christine Pierre is the President of RxTrials Institute (RxTi) and gave a terrific talk.  If you would like to meet her or discuss this topic further, perhaps you would like to attend the Site Solutions Summit in October.  I haven't booked my travel yet but I am definitely considering going.

Early bird rates are available now!
I am excited to see the next-generatiion startup
tracker product when it is released. 
Then, a few days ago I traveled to downtown San Francisco, CA to visit the offices of goBalto. This innovative company has developed a web-based platform for Clinical Study Startup, Tracker™. The software "enables clinical trials sponsors to collaborate with multiple partners directly from the web in a transparent and regulatory compliant manner".  They invited me to a demo of their next generation product to participate in a user feedback session.  I was really impressed and found them to be extremely forward-thinking.  I am excited to see the product when it is released.

So, all of this has led me to develop a new series for the blog focusing on: Site Startup.  In addition to my work as a Lead CRA, I have been involved in clinical study site startup for a variety of pharmaceutical companies pretty much without interruption for the past 28 months.  Whoa, over 2 years you say?  "Surely, Nadia you must have tremendous experience launching study sites for many clinical trials in that time!"  Yeah, well uh, regrettably, no.  However, in that time I have worked with six disparate clinical operations teams and supported the process of opening a few hundred sites in five different countries (mostly Phase II trial sites).

As a regional monitor at a CRO, I would routinely assist with pre-study site selection visits and administration of feasibility questionnaires but the majority of my work was 85% regional monitoring and site management once sites were open.  Since I have moved to an in-house role, I spend a lot more time in the start-up side of things, buried in spreadsheets, trackers, dashboards, and demands from my boss and the board of directors, so I have gleaned some valuable insights. We'll be stepping through several broad topics of site startup in the coming weeks including:
  • What are the typical milestones of site startup?
  • What is feasibility? How do sponsors choose which clinical trial sites they work with?
  • What is an essential document package and a regulatory submission?
  • Informed Consent Form templates
  • Site Budgets
  • Why do contracts take so long? How are they complicated?
  • Developing Investigative Site Patient Recruitment Plans
  • IRB submissions
  • Calculating Investigational Product needs
  • Providing study supplies and source documents
  • Ensuring sites are adequately trained and prepared to participate
  • What correspondence goes in the Trial Master File?
  • Metrics, trackers, reports, and dashboards 
  • Gating tasks...bottlenecks
  • Lessons learned, where did the process breakdown?
  • How to speed up site startup?
What is missing from this list? Do you have other questions or topics that you would like me to cover related to site startup? Please leave me a comment or drop me an email at leadcra-mail@yahoo.com.

Wednesday, April 13, 2011

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.

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.



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