SOP 09
- Associated document 1 Legal Definitions of Medical Devices [PDF 90KB]
- Associated document 2 Early Engagement Meeting Clarification Tool [PDF 126KB]
- Associated document 3 Clinical Investigation Plan template [DOC 397KB]
- Associated document 4 JRMO document submission checklist [DOC 86KB]
- Associated document 5 Clinical Investigations Guidance for GCP and Governance section staff [DOC 52KB]
- Associated document 6 Sponsor CI agreement (Barts Health) (Not a public document)
- Associated document 7 Sponsor CI agreement (Queen Mary) (Not a public document)
- Associated document 8 GCP Managers checklist [DOC 53KB]
- Associated document 9 Governance team sponsorship review for Clinical Investigations [DOC 64KB]
- Associated document 10a Barts Health Medical Devices sponsorship with conditions letter (Not a public document)
- Associated document 10b Queen Mary Medical Devices sponsorship with conditions letter (Not a public document)
- Associated document 11 Sponsorship with conditions email template (Not a public document)
- Associated document 12 Final governance meeting report [DOC 72KB]
- Associated document 13 Sponsors Confirmation of sponsorship email (Not a public document)
The effective date of the SOP has been extended to April 2024
