eTMF for the 99%

August 29, 2013

  • eTMF Resources

In this blog, we usually focus on regulatory guidance concerning the Trial Master File and best practices around business processes related to TMF and eTMF. Today’s post discusses how eTMF technology is often designed in such a way that users struggle with using it efficiently and successfully. Most often, these issues arise because of the assumption that all users of the eTMF are “power users” just like the people who designed it. But many eTMF users are more clerical in nature and while certainly competent, probably not the type of people who know all the keyboard shortcuts, Microsoft conventions, and other accelerators that the system designers assumed that “everyone” knows and uses.

To compound the situation, eTMF users may be temporary contract employees, people who are only working on a few trials, or other types of users who move in and out of the system briefly. Minimizing training requirements for them can significant improve productivity and reduce support requests.

Here are some of the assumptions I have seen built into many eTMF systems. If you are comfortable with all of these practices, count yourself as part of the 1%. But do you really want a system that is built for the 1%, or for the 99%?

  • Users know how to use Excel, right? So they will definitely know how to filter, sort and re-arrange columns. Wrong. Those of us who use Excel often are very comfortable with this approach. But a surprising number of people don’t use Excel, or use it at a very rudimentary level. These users may not even be aware that they can sort and filter – or they may apply a filter, log out, log back in some time later, and forget that they have applied a filter. Compare this with the facet style navigation used to reduce a results set on Amazon, eBay, and other commercial sites. No one had to be trained to use these tools.
  • Users know that they should just save browser shortcuts to their favorite pages and important documents, and that they can email those pages to others. In fact, creating an internet shortcut within the eTMF – and then setting up folders to manage a large number of shortcuts – would not occur to many people. In addition, all that does is give you access to either a page or one document at a time. The eTMF itself should manage favorites and keep track of recent documents – and present them as a list so that users can take action on multiple documents in that list.
  • Users know that multi-select is as simple as holding down the control key and clicking on multiple documents, then right-clicking to do something. In fact, many users are entirely unaware of the various multi-select options –which also don’t work well when everything you want to select is not visible on a single page. Providing an alternative such as a clipboard is easier to understand and use.
  • Users will page through sets of documents to find the one they are looking for. If you go back to the Amazon or eBay parallel – how many pages of results do you look through before giving up? Probably no more than a few. In eTMF, this problem is compounded by the fact that a single study could contain as many as 20,000 documents – not something you could page through. It’s important to give users an approach that lets then narrow their results set with a few clicks.
  • Users can deal with long lists such as studies, sites, etc. by just using type ahead (if anything). Users should not have to scroll through a list of 1000 sites to find a site they need! Type-ahead is often a poor solution as site IDs may not be unique until the last character. For lists containing a large number of values, intelligent forms of navigation should be provided.

Although similar issues exist in EDMS across life sciences, other systems such as regulatory and SOP tend to have a higher percentage of experienced, long-term users. For eTMF, it’s a good idea to look at the system as if you were the temporary worker hired to index documents for a large study. Is the UI really designed to support this user – or to support the 99% in general?