The TMF Hierarchy of Needs

December 3, 2013

  • eTMF Best Practices

In a recent Information Management article, Kelle O’Neal examined how corporate behavior – with respect to information systems – could be explained by Maslow’s Hierarchy of Needs.  In this article, we will examine how Maslow’s Hierarchy of Needs might explicitly be applied to the world of Trial Master File.

Abraham Maslow, a 20th century American psychologist, defined a progressive set of human needs culminating in self-actualization.  The graphic below depicts the five levels of need, each building upon and dependent on the prior level.  At the base, we see Physiological needs which must be fulfilled in order to sustain life and before subsequent levels may be recognized and pursued.  Once Physiological needs are met, Safety needs including security, employment and health may be pursued to ensure the continued prosperity of the individual.  Afterwards, higher level needs such as Love and Esteem may be sought and obtained further enriching and fulfilling the individual.  Finally leading to a peak of Self-Actualization and the fulfillment of the person’s full potential.

Hierarchy of Needs

Examining these levels and mapping them to the TMF process, we might arrive at something like the following (from the foundational levels on up):

Physiological: This level represents the set of base capabilities required to declare that you have a TMF and include the processes of document receipt, some form of indexing, storage and the ability to find and retrieve content.   We can name this level Base Capability.

Safety:  This level is focused on sustainability and establishing stable and repeatable TMF processes capable of being shared and extended to others for their use and perpetuation of the system.  We will name this level Sustainable Process.

Love:  No, that’s not gonna happen!  Perhaps we look at Belonging.  At this point the TMF is recognized as fulfilling the need.  It is integrated with other upstream and downstream processes and it has demonstrated value.  We will name this level Return on Investment.

Esteem: The TMF is highly tuned, optimized and efficient.  It is a model for other process areas and is recognized and referenced as an example of best practice. We will name this level Best Practice.

Self-Actualization:  The TMF is driving business process excellence – not simply running the TMF process optimally – but providing outputs and insights that improve clinical trial execution and reduce time to file. We will name this level World Class or perhaps Process Actualization.

The result is the TMF Hierarchy of Needs which presents a general framework for gauging and planning the overall maturity of a TMF implementation.

 

TMF Hierarchy of Needs

 TMF Hierarchy of Needs

 

In order to move into World Class – Process-Actualization, the TMF must become actionable outside of the silo of content management and take on a strategic role in optimizing the execution of the trial as a whole.   It must usher in a shift from an after-the-fact document archive mentality to the use of TMF as a real-time planning, monitoring and decision making tool.  This is accomplished within Wingspan eTMF through a set of robust analytical dashboards which mine the rich set of operational metrics that are collected across the study, country and site levels. The ability to contrast and compare real-time trial operations and quality between countries and sites and examine the relative performance of trial partners elevates the role of TMF from back office necessity to prominent senior management decision making tool and places Wingspan eTMF at the pinnacle of the TMF pyramid.