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
- Study Progress and Safety Monitoring
- Appendix 1 - Guidance On Study Monitoring Reports
- Appendix 2 - Study Progress and Safety Monitoring Plan (SPSMP) Template
- Appendix 3 - DAIDS Standing Data and Safety Monitoring Boards (DSMBs)
- Appendix 4 - Charter for the Data and Safety Monitoring Boards of the Division of AIDS
- Appendix 5 - DAIDS Safety Monitoring Committee (SMC) Guidelines
- Appendix 6 - DAIDS Independent Safety Monitor (ISM) Guidelines
- Requirements for Data Management and Statistics for Clinical Trials
- Identification and Classification of Critical Events: Site Responsibilities
- Critical Events Manual
Content last reviewed on December 9, 2016