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February 18 , 2020

There has been ongoing confusion around the intersection of Vanessa's Law, Serious Adverse Events (SAEs), and Reporting Learning System (RLS) requirements for reporting.

Key Messages for Principal Investigators:

  • Adverse events, close calls and hazards should be reported (voluntary) through the RLS system;
  • All clinically serious adverse events must be reported to the most responsible Covenant Health practitioner and manager;
  • All adverse events – SAEs and including SADRs, must be reported to the study sponsor as established within the study protocol; and
  • All adverse events – SAEs and including SADRs, must be reported to the local REB(s) that approved the study.

 

The entire Guidance document can also be found on our website under <Research Community<Tools & Resources

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