file:///usr/local/tomcat/apache-tomcat-5.5.17/webapps/XML4PharmaServer/temp/xform2007218153938.0994.xhtml F_AE Test Subject system-generated 2007-02-18 15:39:38.099+01:00 0 0 enter text 2007-02-182007-02-18 2007-02-18 P0DT0H 0 1 0 1 1

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Subject outcome Subject remains in study 1 Withdrawn from study 2 Lost to follow-up 3 Death 4

Insert after selected Group Remove selected Group

Submit Data Reset

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