Protocol Title
Item
Protocol Title
text
Site Number
Item
Site Number
integer
Subject ID
Item
Subject ID
integer
Visit Date
Item
Visit Date
date
Prior and Concomitant Medications
Item
Were any Concomitant medications taken by the subject ___ days before or during the study? If Yes, record below.
text
Prior and Concomitant Medications
Item
If yes, how many days before?
integer
Prior and Concomitant Medications
Item
Prior and Concomitant Medications: No
boolean
Medication
Item
Medication
text
Route
Item
Route (see Description)
integer
Route
Item
Route: If Other, please specify
text
Frequency
Item
Frequency (see Description)
integer
Frequency
Item
Frequency: If Other, please specify
text
Indication
Item
Indication
text
Start Date
Item
Start Date
date
Stop Date
Item
Stop Date OR Check If continuing at study end
date
Item
Was medication used to treat AE?
text
Code List
Was medication used to treat AE?
Specification
Item
If Yes, specify event
text