Protocol Title
Item
Protocol Title
text
Site Number
Item
Site Number
integer
Subject ID
Item
Subject ID
integer
1. Did the subject meet the eligibility requirements for this study?
Item
1. Did the subject meet the eligibility requirements for this study? (see description)
boolean
a. Date randomized (See description)
Item
a. Date randomized (See description)
date
Item
b. If eligible and not randomized, indicate reason
text
Code List
b. If eligible and not randomized, indicate reason
CL Item
Failed to return (1)
CL Item
Declined participation (2)
CL Item
Other (specify) (3)
If Other, please specify
Item
If Other, please specify
text
2. Randomized to study group or treatment
Item
2. Randomized to study group or treatment
text
Completed by (initials)
Item
Completed by (initials)
text
Date completed
Item
Date completed
date