SOP 45
SOP 45 Study Specific Essential File Documentation [PDF 264KB]
- Associated Document 1 TMF Checklist for MHRA regulated Studies (single site) [DOC 80KB]
- Associated Document 2 TMF Checklist for MHRA Regulated Studies (Multi-Site) [DOC 81KB]
- Associated Document 3 TMF Checklist for Interventional and Research Studies (Single Site) [DOC 75KB]
- Associated Document 4 TMF Checklist for Interventional and Research Studies (Multi-Site) [DOC 84KB]
- Associated Document 5 Source Data Agreement [DOC 109KB]
- Associated Document 6 ISF Checklist for MHRA Regulated Studies [DOC 67KB]
- Associated Document 7 ISF checklist for Interventional and Research Studies [DOC 71KB]
- Associated Document 8 Pharmacy site checklist [DOC 61KB]
- Template 1 Enrolment log [DOC 50KB]
- Template 2 Site delegation log [DOC 51KB]
- Template 3 Coordinating team delegation log [DOC 54KB]
- Template 4 Document version control log [DOC 61KB]
- Template 5 PIS ICF and GP letter version control log [DOC 68KB]
- Template 6 Amendment Log [DOC 44KB]
- Template 7 File note template [DOC 151KB]
- Template 8 File note log [DOC 39KB]
- Template 9 Deviation log [DOC 44KB]
- Template 10 Study specific training log [DOC 51KB]