Adverse Event Log

Variable / Field Name	Section Header	Field Type	Field Label	Choices or Calculations
ae_event		text	Adverse Event and relationship to the study procedure
ae_sae		yesno	Is this a serious adverse event (SAE)?	1, Yes ; 0, No
sae_criteria		radio	SAE criteria	1, Death ; 2, Life threatening ; 3, Hospitalisation ; 4, Medically significant ; 5, Congenital abnormality/birth defect
ae_severity		radio	Severity	1, Mild ; 2, Moderate ; 3, Severe ; 4, Fatal
ae_action		dropdown	Action	0, None ; 1, Study interrupted ; 2, Drug therapy given ; 3, Non-drug therapy given
ae_action_det		notes	Action (Further details if required)
ae_start_date		text	Start Date
ae_stop_date		text	Stop Date
ae_outcome		radio	Outcome	1, Resolved ; 2, Resolved with sequelae ; 3, Ongoing ; 4, Fatal ; 5, Unknown