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Serious Adverse Events

This section will be helpful for CRAs who need to report a Serious Adverse Event for a subject. 

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*Institutional required fields marked in red, bold font

 

Common Terminology Criteria for Adverse Events (CTCAE):

  •  Set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy.
  • Each oncology protocol should specify which version of the CTCAE should be utilized.
  • The CTCAE version can be updated/changed in the management tab of the PC console by the regulatory coordinator as long as no SAEs have been documented.