Safety Reports

All DSMB Reports must be forwarded as soon as they are available and must be accompanied by a letter from the Local Principal Investigator indicating that s/he accepts the findings and recommendations of the DSMB.

Sponsor-generated reports must contain the following information:

  • Total number of participants
  • Total number of serious adverse events
  • Total number of serious adverse events likely related to the study drug/intervention
  • Whether the study should continue

The Sponsor-generated report must be accompanied by a Cover Letter from the Local Principal Investigator indicating his/her assessment of the seriousness and causality of the side effects and whether in his/her opinion they alter the risk/benefit ratio and/or require changes to the Information/Consent documents, Protocol, or other study documents.