eCRF XForms example
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Form: Adverse Events
Study Event ID
Group: Common
Site number
Must be an integer.
Subject ID
Visit Date
Must be a valid date. Correct format is: yyyy-mm-dd
Visit Start Time
Must be a valid time. Correct format is: hh:mm:ss
Group: Adverse events
Has the subject experienced any adverse events
No
0
Yes
1
Group: Adverse events
Insert after selected Group
Remove selected Group
Event No.
Must be an integer.Value must be lower than 1000
Adverse event
Start Date
Must be a valid date. Correct format is: yyyy-mm-dd
Is the adverse event still continuing
No
0
Yes
1
Stop Date
Must be a valid date. Correct format is: yyyy-mm-dd
Duration of the adverse event
Must be a valid duration. Correct format is: PnYnMnDTnHnMnS
Was event serious
No
0
Yes
1
Severity
Mild
1
Moderate
2
Severe
3
Is there a reasonable possibility that the AE may have been caused by the study drug
No
0
Yes
1
Action taken with study drug
None
1
Study drug regimen changed
2
Temporarily stopped study drug
3
Study drug discontinued
4
Subject outcome
Subject remains in study
1
Withdrawn from study
2
Lost to follow-up
3
Death
4
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