Do you have a regulatory soul?
A VP of Regulation & Compliance told me that I did, a few months ago, when I collaborated with them to build a repeatable folder structure that aligns with the updated eTMF Reference Model guidelines that the DIA released last year.
Honestly, though, if you’re going to have valuable files that document a sensitive procedure like a clinical trial, then making sure that they have a place, and that they are controlled, is important. Really, it’s more than just important…it’s essential to have a place for everything, and everything in its place, especially when it comes time to be finding, amending, and auditing these files.
You don’t necessarily need to have a regulatory soul to think that’s a good idea, am I right?
An electronic Trial Master File (eTMF) is an exhaustive set of documents that an organization (like a pharmaceutical company, or a hospital research center) will assemble, in order to fully document the clinical trials of the treatment that they are testing. Clinical trials have so many different aspects that need to be fully documented, and fully audited, not least because of the ethical considerations that are key due to utilization of human subjects.
The documentation comes from several different sources, and needs to be regulated so that only authorized persons are allowed to access it—it can be difficult to assemble, and to have available, and yet, collaboration is a vast part of what needs to happen with these files. Reconciling these various needs has caused a lot of pain and wasted a lot of time in the industry.
In 2010, the Drug Industry Association (DIA) formed the TMF Reference Model Group, which includes hundreds of members from around the world. This group created the TMF Reference Model, which it released in 2010, and which it updated in 2012. The TMF Reference Model is a set of guidelines, that clearly delineate what documentation is to be filed where, and who should have access to it.
The TMF Reference Model is being adopted by many organizations in the industry in order to organize their data, and have a clear idea about where documentation is, and where it is lacking.
The information that is being gathered and organized in a TMF is sensitive, critical information. It documents that people are doing things properly, that patients are being informed about their rights, that they aren’t being coerced or misled. It documents that the investigators are fully vetted, and that their results are unbiased and reasonable. Everything, every piece of information that is related to a trial is in one central, secure location, where it can be easily audited.
This is difficult. Clinical trials take place at multiple sites, often globally, and it means that not only do you need documentation to keep the processes and the Contract Research Organizations (CRO’s) as transparent as possible, it also means that all parties need to have a way to access documents, and a place to collectively store them, while managing things like version control and audit trails.
There are different kinds of software that people have been using to tackle this, including Clinical Trial Management Systems (CTMS), Document Management Systems (DMS), and eTMF systems… and none of the answers are wrong (entirely). It depends on what an organization looks like, what resources it already has in place, and what areas need more support than others. In fact, integrating two or more systems, if done correctly, can be the smoothest working solution altogether.
In Part Two, I’ll be sharing how I integrated the eTMF Reference Model guidelines with some of the capabilities inherent in my software, Document Locator, and going over how the two can buttress each other, and to what purpose. See you there!