We have SOPs to define our processes throughout the different stages of our CSCs. These are version controlled, and regularly reviewed and updated to align with improvements in the CSC process.

Examples of the SOPs we use include:

Pre Project Tasks
• Microsoft Forms Questionnaires
• Sizing a CSC
• Commission Agreement
• Finance for CSCs

Stage 1: Project Start Up
• Creating a Project in SharePoint
• Roles and Responsibilities in CSCs

Stage 2: Initiation
• Scoping a CSC
• Clinical Risk Management Plan (CRMP)
• Booking Regular CSC Meetings
• Clinical Risk Management File (CRMF)
• CSC Programme Digital Solution Documentation
• Reviewing Previous CSCs
• Subject Matter Experts and Other Contacts
• Orientation Workshop

Stage 3: Managing Product Delivery
• Hazard Workshop
• SME Sessions
• Developing a Hazard Mind Map
• Issues Clinic
• Gathering Evidence

Stage 4: Managing Product Delivery
• Mapping Hazards, Causes and Controls
• Evidence Review
• Creating Hazard Log
• Clinical Impact Statements
• Initial Risk Scoring
• Clinical Safety Case Report
• Control Evidence List

Stage 5: Managing Product Delivery
• Residual Risk Scoring

Stage 6: Managing Product Delivery
• Final CSC Report Presentation
• Clinical Risk Management File Handover
• CSC Project Lessons Learned