Guidance

Listed below are links to internal guidance documents:

• HSCR-GD001 How to Save and Export an IRAS as a PDF V1.0 07052025
• HSCR-GD002 How to Submit Your IRAS Application V1.0 08112024
• HSCR-GD004 Review Route Route Guide V1.0 06052025
• HSCR-GD005 Risk Scoring Matrix V1.4 02072024
• HSCR-GD006 Participant Information Sheet GDPR Wording V1.0 07052025
• HSCR-GD007 Involving Adults Who Lack Capacity in Research V1.0 16072025
• HSCR-FLOW002 Post-award Sponsorship Request Flowchart V1.0 31102024
• HSCR-FLOW003 Identifying Approvals Ethics Sponsorship and Subsequent Applic
• HSCR-FLOW006 Adverse Event Documenting and Reporting V1.0 16072025
• HSCR-FLOW007 GCP Breach and Protocol Non-Compliance V1.0 06082025
• HSCR-FLOW008 End of Study Procedure Flow Chart V1.0 02072025
• HSCR-FLOW009 Approvals for Involving Adults Lacking Capacity V1.0 16072025

Standard Operating Procedures

Listed below are links to internal Standard Operating Procedures:

• HSCR-SOP001B Research Sponsorship Procedure V2.0 06052025
• HSCR-SOP002 Project Risk Assessment V2.0 07052025
• HSCR-SOP003 Adverse Event Procedure V1.0 16072025
• HCSR-SOP004 GCP Breach and Protocol Non-Compliance V1.0 06082025
• HSCR-SOP006 Amendments to LU Sponsored Studies V1.0 20052025
• HSCR-SOP007 End of Study Procedure for LU Sponsored Studies V1.0 16062025

Forms

Listed below are links to internal forms:

• HSCR-FORM002 Post-Award Sponsorship Request Form V1.0 12012024
• HSCR-FORM003 External Sponsor Collaboration Form V1.0 07112024
• HSCR-FORM004 CI Responsibilities Declaration V1.0 06052025 - please request via the sponsorship team
• HSCR-FORM005 Project Risk Assessment Form V1.0 07052025
• HSCR-FORM006 Adverse Event Form V1.0 17102024
• HSCR-FORM007 GCP Breach and Protocol Non-Compliance V1.0 06082025

Templates

Listed below are links to internal templates: