Set CTCAE Version to the version specified in the Clinical Trial Detail.
In Common Toxicities Quick Select, find and select a common toxicity. The values in this list depend on the selected CTCAE Version. iKnowMed fills in the Category and Type for you.
To indicate this event is a Severe Adverse Event, check SAE.
Tip: When checked, "(SAE)" displays in the Type column of the Adverse Event list (see second image).
In Grade, select the reaction experienced.
Enter the Onset Date and, if known, the Resolution Date.
Tip: You can enter the date in various formats: the full date, just the year and month, or simply the year.
In Related to Study Drug, select the probability of this Adverse Event being related to a study drug.
Select what this Adverse Event is Most likely related to.
Find and select a Medication related to this Adverse Event.
Select one or more actions in Action taken.
Tip: To select an additional action, hold down the CTRL key when you click the action in the list.
Enter Comments.
Click SAVE.

About Adverse Events