Study Name
Item
Study Name
text
Site Number
Item
Site Number
integer
Visit Date
Item
Visit Date
date
Did this participant have any protocol deviations?
Item
Did this participant have any protocol deviations?
boolean
Description of Protocol Deviation
Item
Description of Protocol Deviation
text
Deviation Category (See Description)
Item
Deviation Category (See Description)
text
Deviation Code
Item
Deviation Code
integer
Date Deviation Occurred
Item
Date Deviation Occurred
date
Date IRB Notified (if applicable)
Item
Date IRB Notified (if applicable)
date
Principal Investigator´s Signature
Item
Principal Investigator´s Signature
text
Date Signed
Item
Date Signed
date