APPENDIX 3: Below is a template form adapt for your trial. – EXPEDITED SAFETY REPORT FORM Reporting requirement: All sites to report to Sponsor-Investigator all *SAEs, SUSARs and USMs within 24 hours of staff becoming aware of the event. trial *Except those identified in the protocol as not needing immediate reporting HREC Reference # Project title Section A: To be completed by the Site Site: Site Principal Investigator: Participant Enrolment OR Randomisation No.: Date the safety occurred: Date Local Site Principal Investigator became aware of the safety event: Participant’s date of birth, age and weight: Event description and management: Event outcome (synopsis): Screening Trial phase (amend to reflect Treatment protocol) Follow Up Relationship to the trial drug Unrelated Unlikely to be related Possibly related Probably related Expectedness (only complete for SAEs that are Not applicable probably/possibly related): Expected *Unexpected
APPENDIX 3: Below is a template form – adapt for your trial. EXPEDITED SAFETY REPORT FORM Reporting requirement: All sites to report to Sponsor-Investigator all *SAEs, SUSARs and USMs within 24 hours of trial staff becoming aware of the event. *Except those identified in the protocol as not needing immediate reporting HREC Reference # Project title Section A: To be completed by the Site Site: Site Principal Investigator: Participant Enrolment OR Randomisation No.: Date the safety occurred: Date Local Site Principal Investigator became aware of the safety event: Participant’s date of birth, age and weight: Event description and management: Event outcome (synopsis): Trial phase (amend to reflect protocol) Screening Treatment Follow Up Relationship to the trial drug Unrelated Unlikely to be related Possibly related Probably related Expectedness (only complete for SAEs that are probably/possibly related): Not applicable Expected *Unexpected
2018_05_16_clin_trial_imp_annotated_prot_template_final.docx