This is the first in a series of blog posts sharing the expertise and voices of SureClinical employees, advisors and customers. We welcome your feedback and your own experiences about your own digital journey.
As a consultant CRA with more than a decade of experience, I took on the assignment of managing the essential TMF documents for two large phase 3 dermatology studies in 2007 thinking “This won’t be so bad!” I bought a couple of new fireproof filing cabinets, made file labels and was ready to go. Six months later I was regretting my decision. Daily FedEx deliveries filled my office with more paper than the downtown library. Not only was the volume overwhelming, but those deliveries invariably contained problem documents: missing pages, unsigned “originals”, the mystery document, etc. I was overwhelmed with keeping up with the filing and indexing of all these documents along with making sure errors were addressed. Auditors were coming. Worries about how I could ever deem these paper files as complete and audit ready kept me up at night. Vacations were out of the question.
Sound familiar? Everyone managing clinical trials has a similar story. The average (if there is such a thing) clinical trial has over 3000 documents – some I’ve worked with have over 10,000. Our industry is one of the most highly regulated, requiring these documents to be filed, classified and checked for expiration, and submitted in a very specific format. It’s rare that you get to touch a document only once.
Clinical trial management is a textbook case for the benefits of going digital
The most conservative estimates show a 20% capacity increase by the same staff by going digital, but most are significantly higher. And, if productivity isn’t enough of a driver alone, anyone submitting to the FDA will need to do so digitally to comply with CFR-21 Part 11 requirements.
As a CRA, with now a couple of decades of experience, I’ve had the opportunity to review a LOT of eTMF systems in my career. While this list isn’t comprehensive, I thought I’d share my top criteria for any eTMF.
Top 5 must-haves in any eTMF
Intuitive User Interface
As a visual person, I need to SEE the document and the filing structure at the same time. Systems that require users to download the document before it can be viewed are not sustainable solutions. A user must be able to easily upload, tag, sort and see the eTMF contents. Keep it simple and easy! We all have multiple systems and logins to keep track of.
Trial Master Structure
The best way to organize vast amounts of data is to structure it. I look for an eTMF system that follows well-accepted standards, such as the OASIS reference model. At the same time, every client has slightly different needs, so I need to be able to customize. That’s a lot easier to accomplish when starting with a baseline. A well-defined structure with metadata makes it possible for the automated tagging and classification of documents, which is a huge time saver, and helps find the document when I invariably need it later.
Automated Workflows and Reporting
Automating processes and workflows is where the biggest bang for the buck comes in when going digital. Setting up workflows in advance and automated tracking and alerts saves not only time but significantly reduces risk. Personally, I love when I can take a quick action on an alert from my phone when I’m on the road. And, the ability to know in advance when I’m at risk and act on it saves me lots of sleepless nights.
FDA and EC-compliant digital signing
Wet signatures should be a thing of the past. Digital signing is a huge paper and time saver. In the click of a button, I can send out a document for review and signature and have it returned typically within hours. That same wet signing process took days in the best case, and often weeks or months. Considering the sheer amount of signatures needed, digital signing savings alone is typically enough to rationalize a decision to go digital.
Gotcha: ESigning and Digital Signing that is FDA and EC-compliant are two different things. Not all systems meet those guidelines. With SureClinical, I can send out documents to hundreds of sites, allow them to upload via a secure portal and have the document automatically tagged and classified into my eTMF. This alone is one of the biggest productivity wins.
Full TMF Search
This may sound obvious, but I need to be able to find specific documents when I need them. When looking at eTMF systems, test them out. Most TMF systems can support structured documents, but its usability to me as a user is highly dependent on my ability to locate relevant content in a search. How easy that is for me as a user is dependent on strong and comprehensive metadata tagging in my system. That level of sophistication in search makes all the difference between a place to store documents and a highly usable system.
Fast forward 12 years and now I can manage the regulatory documents for 5-6 concurrent large studies easily and mostly stress free. The difference is the advance of eTMF systems that manage digital copies of all the documents in sortable, searchable and reportable databases. A few clicks on the keyboard and I can be assured of what is in the eTMF, what is missing, and which documents need corrections or updates. With the advent of Part 11-compliant digital signatures, there are no longer any of those “hall of shame” documents that are scans and rescans of wet ink signature pages. Mobile client solutions allow access to the eTMF anywhere from any device. Auditors can inspect the eTMF from their home office and do not need to knock on my door!
I am planning my next vacation.
Contact SureClinical to learn more about optimizing the move to digital.
About the Author
Catherine is a highly qualified clinical research professional who specializes in clinical project management as well as eTMF consulting. She has over 20 years of experience working in clinical trials for pharma, biotech and device companies overseeing multiple projects, teams, vendors and eTMFs. In her free time, you can catch Catherine jumping horses and riding along bike trails in Lake Tahoe. Connect with Catherine today via LinkedIn.