Kentucky State University Office of Research and Innovation 400 E Main St, Frankfort KY, 40601 ORI@KYSU.EDU (502) 597-5997
Modification Request Form
PI Signature
The quick brown fox jumps over the lazy dog.
Date
PI signature
Date
Modification Details
1 Address change for protocol correspondence?
If yes, indicate new address:
Yes
6 No
New address
Study title
2 Study Title:
Title change? 6 Yes
6 Yes
If yes, indicate new title:
6 No
New title
3 Is this a one-time request for a deviation from the currently approved protocol, or an exception to the currently approved enrollment criteria? Yes No
Yes
Yes
4 Consent / Assent Form change?
6 No
Yes
If yes, be sure changes are reflected in all revised consent/assent documents and any applicable HIPAA documents.
5 Check one:
6 This modification does NOT increase risk to study participants. 6 This modification may or will increase risk to study participants.
no_increase
no_increase
6 Is this modification request due to an Unanticipated Problem or Adverse Event? Yes No
Yes
Yes
7 In your professional opinion, does this modification involve information that might relate to a subject's willingness to continue to take part in the research? Yes No If yes, state how the information will be communicated to subjects (i.e., re-consent, send letter, etc.):
Yes
Yes
How communicated
Research & Innovation (ORI) · IRB Guidelines · ORI@kysu.edu