Protocol Title
Item
Protocol Title
text
Site Number
Item
Site Number
integer
Subject ID
Item
Subject ID
integer
Visit Date
Item
Visit Date
date
Item
1. Did the subject attend this visit?
text
Code List
1. Did the subject attend this visit?
CL Item
Yes (If yes, continue) (1)
CL Item
No (If no, enter comments below) (2)
2. Study Visit
Item
2. Study Visit: Date of Informed Consent Signed
date
Study Visit
Item
Study Visit: Demographics
boolean
Study Visit
Item
Study Visit: Medical History
boolean
Study Visit
Item
Study Visit: Vital Signs
boolean
Study Visit
Item
Study Visit: Physical Exam
boolean
Study Visit
Item
Study Visit: Prior and Concomitant Medication
boolean
Study Visit
Item
Study Visit: Inclusion/Exclusion Criteria
boolean
Study Visit
Item
Study Visit: Randomization
boolean
Study Visit
Item
Study Visit Enrollment
boolean
3. Is the subject continuing in the study?
Item
3. Is the subject continuing in the study?
boolean
Comments
Item
Comments
text
Completed by
Item
Completed by (initials)
text
Date completed
Item
Date completed
date