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C7 Method of Contract Change Agreed.

“The best laid schemes o' mice an' men Gang aft agley” (“To a Mouse” by Robert Burns). No matter how good our project plans might be it can go awry.

Clinical research protocols are becoming more complex which brings with it an increased uncertainty.

Everything we know and don’t know about a project fit into the four-quadrant model below. David Cleden 2009 Managing Uncertainty Published by Gower

The two areas of concern with reference to contract changes are risk and uncertainty. The problem with contact changes is that they attract transaction costs i.e., the costs related to implementing the change. They can also be contentious and time consuming. An effective risk analysis can help to reduce the need for contract changes by predicting potential problems and either downgrading the risk or putting in place contingency plans. This leaves us with uncertainty: those bolts from the blue. It is important to understand that any deviation from your plan, be it negative or positive, is a potential threat, and that the sooner you recognise the deviation the better.

Despite your risk analysis you may need to amend the plan to take account of the inevitable deviations. To keep transaction costs at a minimum you need an agreed process. The key elements to a change order request leading to a contract change are:

  • Project name

  • Requester name

  • Description of the change 

  • Reason for change

  • Priority

  • Requested implementation date

  • Changes to project timelines

  • Changes to the planned budget

It is important that the process is agreed by all parties and the project governance is aligned to negate potential delays in getting it signed off. Finally, your choice of contact type (pricing criteria) will be an important factor in the number of changes generated. When considering complex projects with a high level of uncertainty, the relatively inflexible outcome-based contracts will generate more change orders than the more flexible behavioral based contracts.

Why is it in the Lab?

No project goes 100% to plan, so you need an agreed process to cope with the inevitable changes. A clear and objective process helps to undermines those relational risks associated with the blame culture that can occur when the project deviates from the plan.



“What I love about the four-quadrant model is that it puts into perspective what you can and cannot control. An appreciation of project uncertainty will hopefully focus the project team on solutions rather than attributing blame.”


“I agree with Roger here, being able to differentiate between what is a real scope change and that which is the realisation of a risk will make a big difference to the narrative and execution around change which will help sustain positive relationships.”


“Yes, I agree - understanding the difference between dealing with risk and dealing with uncertainty is very important and focusing on solutions rather than blame when managing the consequences of high levels of uncertainty is crucial.”

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