HEADER: PI NAME, Protocol or IRB Number, Protocol Short Title

Subject Initials Subject ID Date: / /

Month Day Year

Subject Off Study

Date subject went Off Study: / /

Month Day Year
INDICATE OFF STUDY REASON:
1
Study Activities Completed
2
Side effects of study intervention (complete applicable SAE form or AE Tracking Log)
3
Death
4
Subject lost to follow-up* (provide comments below)
5
Subject refused follow-up* (provide comments below)
6
Other* (provide comments below)
7
Subject withdrew (complete Early Withdrawal section below)
1 2 3
Was subject treatment unblinded? Yes No Not Applicable

Early Withdrawal
Last Visit Completed: Early Withdrawal form not completed

Form Number: Version Date: 01/31/2016 Page 1 of 3

1 4 7
Visit # Visit # Visit #
2 5 8
Visit # Visit # Visit #
3 6
Visit # Visit #
Indicate the primary reason the subject has withdrawn from the study (select only one):
1
Subject deemed eligible but declined participation
2
Subject deemed inappropriate for study participation by the PI
3
Participant was determined to be ineligible after enrollment* (provide comments below)
4
Identification of disease/condition after enrollment that warrants withdrawal*
5
Unable to continue due to personal constraints*
6
Side effects of study intervention * (complete UWI-02-007 Adverse Event Tracking Log)
7
Other *

*Additional explanation required:

FORM COMPLETED BY:

OnCore Entry Instructions:

The Off Study form is not a separate eCRF in OnCore, but rather a standard form for every subject part of the Subject Console.
To enter the off study data, click ‘Follow-up’ menu item on the left side menu bar within the Subject Console. Enter the Off Study
Date field. Select the appropriate Off Study. If the subject withdrew early, select ‘Subject Withdrew’ from the Off study Reason
drop down box, then click the ‘Eligibility’ menu item on the left side menu bar within the Subject Console, and select the Reason
Withdrawn from the drop down menu.