Using a Knowledge Pyramid to Build the Wisdom for a Clinical Trial

In a previous blog (Importance of a Big Picture ), I discussed another use for a program hierarchy to depict a needed activity with multiple threads. In that spirit, I’d like to provide another visual you might consider using as part of your project or program. That visual aid is called a knowledge or DIKW (Data, Information, Knowledge, and Wisdom) Pyramid. The objective is to highlight how each step of the pyramid answers questions and the value of the data.

I recently had the opportunity to develop a DIKW pyramid during discussions with a client dealing with a potential system harmonization program. This was driven by a conversation with a cross-functional team, including one of the organization's Sr. VPs, who, during the meeting, highlighted the desire to, at some point, harmonize their systems. The future state desired was to have everything in one place, providing a line of sight from a clinical overview. He noted that he looked at it as an Information or Knowledge pyramid. At the close of the meeting, a follow-up was scheduled.

Based on that direction, I felt that if I could develop and present the objective beyond the documented charter requirements, and as I’ve noted in the past, having a single-page pictorial for team members to have as an aid to understanding objectives and scope of an effort is beneficial for all.

So, how did I structure this within the four noted levels? I used the following.

• Data consisted of what is used within the life of the study, from functional areas including:

  • Regulatory

  • Clinical Operational Management

  • Quality

  • Clinical Data Management

  • Finance and Procurement

• Information uses the study data to build the information tier through operational and systematic standards (I.E., Required document templates and limited data entry points…). Systems such as:

  • TMF

  • QMS

  • CTMS

  • IWRS

  • Safety

  • RIM

  • EDC

• Knowledge uses the information stemming from the data to build the needed plans, to collaborate throughout the study, measure KPIs and KPRs, deviations, controlling supply chains. . .

• Wisdom is built through the lower tiers of the pyramid needed to respond successfully to regulatory inspections and ensure the study is closed and archived with a quality TMF telling the whole story.

This was used on a single slide during a follow-up meeting to help understand certain aspects of the charter and open discussions for a desired future state.

Want help with ways to structure your project into a presentational view to simplify the understanding of an effort and help facilitate those discussions? Let's connect.