Change Request Memo

Date:

July 12, 2023

To:

Office of Management and Budget (OMB)

Through:

Reports Clearance Officer, DHHS
Project Clearance Chief, NIH
Project Clearance Liaison, NCI

From:

Michael Montello, Pharm. D., CTEP (National Cancer Institute)

Subject:

Nonmaterial/Non-substantive change request for:
CTSU OPEN Rave Request Form (National Cancer Institute)
(OMB #0925-0753, Expiration Date: 05/31/2024)

This is a request for OMB to approve non-substantive changes to the attached CTSU OPEN Rave
Request Form. The updates to the CTSU OPEN Rave Request Form are updates to Section II a new
question 2.8 (“Will this protocol use IROC credentialing? If yes, indicate each type of credentialing
that will be collected in OPEN (i.e. IMRT, 3D).”), Section IV question 4.3 (“If yes, will this trial use the
standard Phase 2/3 Form Timeliness Windows?” There is also a notation defining the Phase 2/3
Form Timeliness Windows.), and Section IV a new question 4.5 (“What method will be used to assign
reviewable data points in Rave?”). These additional questions are needed as part of the initial
protocol set up in our regulatory application to support new functionality that was added in OPEN
and Rave. The addition of the three questions will not increase the burden to complete the form.
Attached to this request is the revised form (clean and tracked versions). All the changes can be
seen in bold red (additions and strikes) in the “Revised Marks” file.

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