PI Signature

The quick brown fox jumps over the lazy dog.

Date

Modification Details

1 Address change for protocol correspondence?

If yes, indicate new address:

Yes

6 No

2 Study Title:

Title change? 6 Yes

6 Yes

If yes, indicate new title:

6 No

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

4 Consent / Assent Form change?

6 No

5 Check one:

6 This modification does NOT increase risk to study participants. 6 This modification may or will increase risk to study participants.

6 Is this modification request due to an Unanticipated Problem or Adverse Event? Yes No

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