Importance of a Big Picture Program View for a Complex Effort

While most are familiar with the use of a program hierarchal view to depict the projects that make up the overall structure, another valuable use for this type of representation is when putting together a pictorial view of the different threads involved in a critical launch or for a must complete effort that needs to be accomplished to meet another final goal. This single-page picture allows the team to see, from a high level, the different activities required and any other influences that could impact the timeline.

For example, a couple of years back, I worked with multiple business functions in developing the activities required to get us to our targeted timeline for multiple database locks for some pivotal clinical trials that were ongoing at the time. With this one, I had to play around to get what I felt was the best representation of what was needed to reach our goal. At first, I developed the structure from a functional standpoint; however, as I was drafting this, it became clear that this wasn’t the proper format for this effort since this was indeed an all-hands-on-deck need. So, in place of that, I set level 2 as “ongoing” and “one-time” activities that might present a risk to meeting our target.

With that in place, for Level 3 of the hierarchy, we focused on what we determined the major influences were, and we landed on the following activities: 

• For ongoing, we looked at the following:

  • Monthly Data creation and the processes needed to ensure those were all completed and required datasets were generated and, where needed, provided to third-party vendors for further processing or review.

  • Site Ongoing activities highlighted the site’s critical milestone dates.

  • Issue resolution of queries and closing out the query resolution backlog.

• For one-time activities, we considered:

  • Outside influences, including the various required committee reviews.

  • Current development efforts were also factored in; for example, while working on this goal, we implemented a new eTMF.

A checkpoint was put in place aligned with all of the level 3 activities to gauge our readiness which also required an adjudication step (level 4) before we could complete the locks per protocol by study.

This is just one example; as you can see, there isn’t a standard format for this pictorial. The program-level view and sub-levels should reflect the best representation of what you’re trying to accomplish. Do your best to keep the focus as high level as possible so that it is, preferably, a single-page view of the activities, highlighting concurrent and linked tasks.

If you’d like support on developing a program hierarchal structure for a launch or complex milestone needed, let’s connect.