Adverse Events
Form Completion Date
date
Course Number
integer
Course Day Number
(For an adverse event that begins on the first day of the course PRIOR to any study medications being given, select "Y". - For an adverse event that begins on the first day of the course AFTER study medications have been given, select "N".)
boolean
Adverse Event Onset Date
(Leave this field as well as the Outcome field blank if the adverse event is ongoing.)
(Using the pick list to select a CTCAE Common Terminology Criteria for Adverse Events Term. - - In the absence of a specific adverse event term, choose the "Other" term from the appropriate general category and be sure a meaningful adverse event description is entered in the "adverse event description" field.)
text
(Note: For studies using CTCAE version 3.0, this field is CTC category. This field is derived from the selected CTCAE Term.)
(Enter a succinct clinical description of the adverse event. - - Note: This field is mandatory, unless the CTCAE term is the same as the description e.g. nausea, diarrhea.)
(Note: Some grades are disallowed for some categories in the CTCAE. )
(Select one of the following codes to record this evaluation:)
(Enter an explanation when Attribute to Other is selected.)
Unexpected Adverse Event
(Note: Refer to the protocol for the definition of a dose limiting toxicity which should include the grade of the events and the duration of the event. - Note: Mandatory for Phase I Clinical Trials.)
(Indicate if the adverse event was a "serious" event by selecting from the following codes, as per the Code of Federal Regulations 21 Part 312. If multiple categories are applicable, select the worst.)
(Indicate any changes made to the study regimen in response to the adverse event using the following codes.)
(Indicate if additional therapy is required to treat the adverse event.)
(Select the final status of the patient when the adverse event is considered "resolved".)
Adverse Event Expedited Report
Adverse Event Expedited Report to Sponsor
Adverse Event Expedited Report to FDA
Adverse Event Expedited Report to OBA
Adverse Event Report to Manufacturer