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Division of AIDS (DAIDS) Clinical Research 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)

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

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

Critical Events Manual (PDF)


Last Updated May 04, 2010