SECTION G: SERIOUS ADVERSE EVENTS Global Global Local Local Site site Number of SAE’s for number of SAE’s since start reporting period of Summary of LOCAL SITE SAE’s for reporting period Causality Outcome Ref. No./ Previously reported to HREC (Related/ (Resolved/ Participant Date Event (Yes/No) unrelated/ unresolved/ No. unknown) death) SECTION H: PROTOCOL NON-COMPLIANCE (Please attach details) Global South Global Local Local Africa Africa Site Site Number of protocol Total protocol deviations deviations for reporting period Summary of LOCAL SITE DEVIATIONS for reporting period Ref. No. (If applicable) Date Incident Explanation
SECTION G: SERIOUS ADVERSE EVENTS Local Site Global Local site Global Number of SAE’s for reporting period number of SAE’s since start of Summary of LOCAL SITE SAE’s for reporting period Ref. No./ Participant No. Date Event Causality (Related/ unrelated/ unknown) Outcome (Resolved/ unresolved/ death) Previously reported to HREC (Yes/No) SECTION H: PROTOCOL NON-COMPLIANCE (Please attach details) Local Site Africa Global Local Site South Africa Global Number of protocol deviations for reporting period Total protocol deviations Summary of LOCAL SITE DEVIATIONS for reporting period Ref. No. (If applicable) Date Incident Explanation
20150624%20HREC%20Progress%20Report%20Clinical%20Trials%20V2.5.doc.docx