Site 3: (name of site) SAEs Outside South Africa (Provide detailed text here) National Principal Investigator report on other safety concerns Line Listing of all major protocol violations at the site: Protocol Violation is any change, divergence, or departure from the study design or procedures defined in the protocol and well-being and/or the reliability of that might significantly affect a participants’ safety, the study data Protocol Deviation is accidental or unintentional changes to, or non-compliance with the research protocol that does not increase risk or decrease benefit or does not have a significant effect on the participants, safety or well-being; and/or the reliability of the study data. Note: Protocol Deviations must be reported separately to MCC. Major Protocol Violations Comment Site 1: (name of site) Site 2: (name of site) Site 3: (name of site)
Site 3: (name of site) SAEs Outside South Africa National Principal Investigator report on other safety concerns (Provide detailed text here) Line Listing of all major protocol violations at the site: Protocol Violation is any change, divergence, or departure from the study design or procedures defined in the protocol that might significantly affect a participants’ safety, and well-being and/or the reliability of the study data Protocol Deviation is accidental or unintentional changes to, or non-compliance with the research protocol that does not increase risk or decrease benefit or does not have a significant effect on the participants, safety or well-being; and/or the reliability of the study data. Note: Protocol Deviations must be reported separately to MCC. Major Protocol Violations Comment Site 1: (name of site) Site 2: (name of site) Site 3: (name of site)
6970a21f6.27_CT_Six_monthly_progress_report_form_Nov17_v1.docx