SOP 45 - Essential documentation including Trial Master Files and files for all external sites and facilities

• Associated document 1: TMF checklist template
• Associated document 2: TMF site sections checklist template
• Associated document 3: ISF checklist template
• Associated document 4: Pharmacy site file checklist template
• Associated document 5: Enrolment log
• Associated document 6: Site delegation log
• Associated document 7: Co-ordinating team delegation log
• Associated document 8: Protocol version control log
• Associated document 9: PICS, ICF and GP letter version control log
• Associated document 10: Amendment log
• Associated document 11: File note
• Associated document 12: File note log
• Associated document 13: Trial-specific training log
• Associated document 14: Deviation log

This SOP is currently being reviewed by the JRMO.