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SOP 45

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.

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