The Fallacy Of Footnotes Within Clinical Protocols

By Beth Harper, Chief Learning Officer, Pro-ficiency

I want 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.