Division of AIDS (DAIDS) Clinical Research Policies and Standard Procedures Documents

Event Reporting and Safety Monitoring

This section provides links to policies and standard procedures related to requirements for critical event reporting, expedited adverse event reporting, and the monitoring of study progress for safety in DAIDS supported and/or sponsored clinical trials.

Expedited Adverse Event Reporting Policy (PDF)

Study Progress and Safety Monitoring (PDF)

• Appendix 1 - Guidance On Study Monitoring Reports (PDF)
• Appendix 2 - Study Progress and Safety Monitoring Plan (SPSMP) Template (PDF)
• Appendix 3 - DAIDS Standing Data and Safety Monitoring Boards (DSMBs) (PDF)
• Appendix 4 - Charter for the Data and Safety Monitoring Boards of the Division of AIDS (PDF)
• Appendix 5 - DAIDS Safety Monitoring Committee (SMC) Guidelines (PDF)
• Appendix 6 - DAIDS Independent Safety Monitor (ISM) Guidelines (PDF)

Requirements for Data Management and Statistics for DAIDS Funded and/or Sponsored Clinical Trials (PDF)

• Appendix 1 - Data Management Requirements for Data Collection Sites (PDF)
• Appendix 2 - Data Management Requirements for Central Data Management Facilities (PDF)
• Appendix 3 - Statistical Requirements (PDF)

Identification and Classification of Critical Events: Site Responsibilities (PDF)

Critical Events Manual (PDF)

• Appendix 1- Examples of Critical Events (PDF)
• Appendix 2- Determining Which Adverse Events are Unanticipated Problems (PDF)
• Appendix 3- Examples of Corrective Actions(PDF)
• Appendix 4- Reporting Critical Events to DAIDS (PDF)