SOP 45:essential documentation and Trial Master file [PDF 279KB]

• Associated document 1: TMF checklist template [DOC 118KB]
• Associated document 2:TMF site sections checklist template [DOC 69KB]
• Associated document 3: ISF checklist template [DOC 84KB]
• Associated document 4: pharmacy site file checklist template [DOC 75KB]
• Associated document 5: enrolment log [DOC 105KB]
• Associated document 6:site delegation log [DOC 87KB]
• Associated document 7: co-ordinating team delegation log [DOC 37KB]
• Associated document 8: protocol version control log [DOC 135KB]
• Associated document 9: PICS, ICF and GP letter version control log [DOC 147KB]
• Associated document 10:amendment log [DOC 42KB]
• Associated document 11: file note [DOC 169KB]
• Associated document 12: file note log [DOC 34KB]
• Associated document 13: trial-specific training log [DOC 63KB]
• Associated document 14: deviation log [DOC 63KB]

This SOP has exceeded the review date and is currently being reviewed by the JRMO.