Safety

Please note that the effective date for these finalized DAIDS Policies and Standard Procedures is February 5, 2007.

Study Progress and Safety Monitoring  (PDF)

Appendice(s):

• Guidance On Study Monitoring Reports (PDF)
• Study Progress and Safety Monitoring Plan (SPSMP) Template (PDF)
• DAIDS Standing Data and Safety Monitoring Boards (DSMBs) (PDF)
• Charter for the Data and Safety Monitoring Boards of the Division of AIDS (PDF)
• DAIDS Safety Monitoring Committee (SMC) Guidelines (PDF)
• DAIDS Independent Safety Monitor (ISM) Guidelines (PDF)

Expedited Adverse Event Reporting Policy (PDF)

Appendice(s):

• Manual for Expedited Reporting of Adverse Events to DAIDS (PDF)
• Table for Grading the Severity of Adult and Pediatric Adverse Events (PDF)
• Expedited Adverse Event (EAE) Form (PDF)
• Completion Instructions for DAIDS Expedited Adverse Event (EAE) Form (PDF)
• Template Wording for the Expedited Adverse Event Reporting Section of DAIDS-sponsored Protocols (PDF)