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MTN-016

MTN-016. Safety Monitoring and Reporting. Objectives. Apply safety assessment and reporting processes for both woman and their infants participating in MTN-016. Safety Monitoring and Reporting. Unanticipated problems/events related to MTN-016 PARTICIPATION :

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MTN-016

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  1. MTN-016 Safety Monitoring and Reporting

  2. Objectives • Apply safety assessment and reporting processes for both woman and their infants participating in MTN-016.

  3. Safety Monitoring and Reporting • Unanticipated problems/events related to MTN-016 PARTICIPATION: • Are the problem/event and participation in MTN-016 related in time? • Are the problem/event and participation in MTN-016 directly associated? • If yes, IoR to report • Appropriate IRB/EC • MTN-016 DAIDS Medical Officer (Dr. Jeanna Piper) • piperj@niaid.nih.gov

  4. Safety Monitoring and Reporting What if an MTN-016 participant has what appears to be an SAE or EAE? • Any SAE or EAE that is considered reportable in the parent protocol should be reported via the safety reporting system utilized by the parent protocol.

  5. Safety Monitoring and Reporting Women • All AEs related to woman as per ASPIRE reporting guidelines • Fetal loss NOT reportable as AE in ASPIRE • However, medical conditions resulting from or in fetal loss are reportable Infants • Congenital anomalies • Record as part of ASPIRE and MTN-016 Pregnancy Outcome • Complete ASPIRE and EAE reporting form

  6. In the event of pregnancy loss, refer to the ASPIRE protocol & SSP Manual for reporting guidance. Fetal loss is NOT an adverse event in MTN-016 or ASPIRE.

  7. Safety Monitoring and Reporting Social Harms Confirm whether related to MTN-016 participation or to the parent protocol Report on the relevant CRF Consult the MTN-016 team as needed

  8. What is a Critical Event? Any unanticipated study-related incident likely to cause harm or increase risk of harm to participants or others or has a significant adverse impact on study outcomes or integrity. If incident appears to be a critical event, follow all applicable procedures in the DAIDS Critical Event Manual!

  9. Scenario

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