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

Subject Initials Subject ID

Subject Deviation/Unanticipated Event/Violation

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

Start Date*: / / End Date*: / /
Month Day Year Month Day Year

Reported Date: / / Reported By:

Month Day Year
Description of Deviation:

Deviation Category*: (check one)

Consent Deviation
Drug/Device Administration Deviation
Enrollment Deviation
Procedural Deviation
Other

Effect on Patient Care:

Action Taken:

Report to the IRB: Immediately Not Applicable (i.e. does not meet Reportable Event criteria)

Date Reported to the IRB: / /

Month Day Year

Principal Investigator Signature: Date:

OnCore Entry Instructions:

The Subject Deviation/Violation form is not a separate eCRF in OnCore, but rather a standard form for every subject
part of the Subject Console. To enter the Deviation/Violation data, click the ‘Deviations’ menu item on the left side
menu bar within the Subject Console. Click ‘New’ and enter data obtained on the paper version of the form .

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