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U5 Stakeholder engagement plan developed and agreed.

Stakeholder engagement is about getting all of the many and varied people that have a role and or an interest in your project pulling in the same direction. In clinical research some of the key stakeholders like investigators are not affiliated to the either the pharmaceutical sponsor or the Clinical Research Organisation,(CRO), managing the project, however they are ultimately responsible for recruiting suitable patients, so keeping them engaged is vitally important. There are four key steps to devising an effective stakeholder engagement plan.

Key Steps:

  1. Identification of stakeholders.

  2. Assessment of stakeholder relevance.

  3. Effective communication plan.

  4. Feedback to update the original plan.

1 Identification of stakeholders The application of system thinking has been used to identify and prevent risk, (Stewart and Fortune 1995), but it is also an excellent and comprehensive way of identifying stakeholders.

Systems thinking is a way of making sense of the complexity of a project by looking at it holistically. The use of techniques like mind mapping allows us to look at the project as a whole and to identify the relationships that are impacting upon delivery.

2 Assessment of Stakeholder relevance Stakeholders are assessed according to the interest and influence that they have in the project. Stakeholders with:

  • High interest and low influence – Keep in the loop encourage participation.

  • Low interest and low influence – Check occasionally and provide key information.

  • High interest and high influence (Key Players) – Contact regularly and educate thoroughly.

  • Low interest and high influence (Stakeholder that can spoil your day) – Monitor closely give them access to information.

Not all stakeholders are supporters so you also need to be aware of those that could be against your project.

3 Effective Communication Plan.

A communication plan is much more than a list of names and addresses. Below is an example from Project Management Student Learning Guide and workbook (Bo Tonnquest 2009) which ticks all the boxes.

4 Feedback to update the original plan.

The influence and interest of various stakeholders will change as the project progresses. New stakeholders will come into play and others will leave. It is important that your engagement plan is kept up to date.

Why is it in the Lab?

A key success factor in any project is stakeholder satisfaction, so engagement with your stakeholders, especially those with influence over the outcome is essential. The level and nature of the engagement needs to be agreed and understood by the whole project team. People that feel ignored are less likely to perform. Stakeholder recognition does not need to be tackled on a grand scale, regular feedback, especially positive feedback can be a very effective way of downgrading relational risk.



“I really love systems thinking as a way of identifying stakeholders. The use of mind maps and rich pictures make the whole project more accessible decreasing the chance of missing an important stakeholder. I also love the simplicity and power of the Bo Tonnquest communication plan, in particular the question why. Instead of copying in the whole world the question why focuses on who really needs to know.”


“This is such a broad topic expect to see a lot here on this. I have been a huge advocate for systems thinking for many years and its application continues to yield value in all sorts of areas.”

Dave “Systems thinking has been around for a long time but, arguably, given the complexities in contemporary clinical research, it has never been more useful as a tool to help us make sense of these complexities as it is now, specifically in terms of working out how to engage with the multitude of stakeholders that have either an interest in, or influence over, a clinical trial.”

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