The Clinical Safety Case (CSC) work will be managed as a project using PRINCE2 principles. This includes the formation of a project team, the creation of a Project Initiation Document and a Project Plan covering the agreed timescales for delivering the CSC.

Using PRINCE 2 principles helps to:

• clearly define the scope of the CSC
• define timelines on delivery of the CSC products
• clearly define roles and responsibilities
• put in place a governance structure with clear escalation paths