SOP 45 Study Specific Essential File Documentation [PDF 734KB]

• Associated Document 1 TMF Checklist for MHRA regulated Studies (single site) [DOC 63KB]
• Associated Document 2 TMF Checklist for MHRA Regulated Studies (Multi-Site) [DOC 79KB]
• Associated Document 3 TMF Checklist for Interventional and Research Studies (Single Site) [DOC 72KB]
• Associated Document 4 TMF Checklist for Interventional and Research Studies (Multi-Site) [DOC 80KB]
• Associated Document 5  Source Data Agreement [DOC 108KB]
• Associated Document 6 ISF Checklist for MHRA Regulated Studies [DOC 68KB]
• Associated Document 7 ISF checklist for Interventional and Research Studies [DOC 60KB]
• Associated Document 8 Pharmacy site checklist [DOC 56KB]
• Template 1 Enrolment log [DOC 96KB]
• Template 2 Site delegation log [DOC 98KB]
• Template 3 Coordinating team delegation log [DOC 95KB]
• Template 4 Document version control log [DOC 95KB]
• Template 5 PIS ICF and GP letter version control log [DOC 106KB]
• Template 6 Amendment Log [DOC 77KB]
• Template 7 File note template [DOC 186KB]
• Template 8 File note log [DOC 72KB]
• Template 9 Deviation log [DOC 70KB]
• Template 10 Study specific training log [DOC 78KB]