As part of our series covering all the do’s and don’ts surrounding protocols, I wanted to call attention to one of the greatest urban legends in clinical research…the requirement to include endless footnotes (in size 6 or 8 font no less!), at the end of the schedule of assessments in the protocol. I have searched high and low for regulatory guidance documents that mandate such a practice, to no avail. Common protocol templates created by organizations and industry collaboratives vary on their use of footnotes within the templates, but nowhere have I found that this is a requirement to get a protocol approved. Yet, it is a common practice and one that contributes more to non-compliance than just about any other facet of the protocol.
It is not uncommon to see upwards of 21 footnotes in a typical Phase III study. In one recent protocol I evaluated there were 17 footnotes, 6 “*’s” and 8 “notes” provided as part of the schedule of assessments. I confess that I wasn’t sure what the differences were between these and what prompted the decision to use three different formats for conveying the procedural requirements versus just using footnotes. But what I was sure about, is that the sites would have difficulty understanding and complying with the requirements.
The solution is simple. Just add an extra column to the schedule of events with the content of the footnote. Rather than the site having to hunt around for an important footnote that might appear several pages later in the protocol, the information will be readily available and easily readable right next to the required procedure.
Instead of this…
*Be sure to do this procedure prior to the morning dosing on days with fasting labs*
A coworker recently mentioned to me that Elon Musk’s claim to fame has been challenging the norm. The willingness to ask “why are we doing it this way?” has led to some of his innovative discoveries and his success. So I was inspired to ask the hard question for all you protocol writers out there:
“Why are you creating more unnecessary confusion for your sites by using footnotes instead of adding in an extra column to the schedule of assessments?”
It costs nothing but potentially saves hundreds of protocol deviations.
While you may not be rewarded with the billions of dollars that Mr. Musk has acquired for his inventions, challenging the norm when you write or review your next protocol will reap even greater rewards….happy sites….cleaner data…safer subjects. Now that’s what I call a great return on investment!
Beth Harper, Chief Learning Officer at Pro-ficiency, is on a mission to eliminate protocol deviations. Beth brings 35-plus years of experience in clinical research operations to Pro-ficiency, utilizing this knowledge along with her years of creating live protocol simulation training to create cutting-edge simulation training programs at Pro-ficiency. Beth has published and presented extensively in the areas of study feasibility, site selection, patient recruitment, protocol optimization, sponsor/site relationship management and clinical research professional competencies. Beth received her B. S. in Occupational Therapy from the University of Wisconsin and an M.B.A. from the University of Texas.