Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
Time of subject completion or withdrawal
Item
Time of subject completion or withdrawal
time
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
Item
If YES, specify primary reason for withdrawal
text
Code List
If YES, specify primary reason for withdrawal
CL Item
Adverse event (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Sponsor terminated study (5)
If OTHER, specify
Item
If OTHER, specify
text
Item
Case book ready for signature
text
Code List
Case book ready for signature
Office Use 1
Item
Office Use 1
boolean