Log of Deviations, Breaches and Urgent Safety Measures Study Title: EudraCT Number: CI: Site Name and Address: Deviation, Urgent Safety Date Breach, Measure incident Incident Participant Date reported to Serious Breach or Site corrective action Site preventive action reported to added to date number Sponsor Urgent Safety MHRA, REC, R&D log Measure (USM) QA
Log of Deviations, Breaches and Urgent Safety Measures Study Title: EudraCT Number: CI: Site Name and Address: Date incident added to log Incident date Participant number Deviation, Breach, Serious Breach or Urgent Safety Measure (USM) Site corrective action Site preventive action Date reported to Sponsor Urgent Safety Measure reported to MHRA, REC, R&D QA
TMP-QA-51_Log_of_Deviations_Breaches_and_Urgent_Safety_Measures.docx