Justification Memo

D ate: May 2, 2012

To: Office of Management and Budget (OMB)

Through: Keith Tucker, Report Clearance Officer, HHS

Seleda Perryman, Project Clearance Officer, NIH

Vivian Horovitch-Kelley, PRA OMB Project Clearance Liaison, NCI

From: Dr. Mike J. Montello, Pharm. D., CTEP (National Cancer Institute)

Mary Williams, BS (Westat)

Subject: Nonmaterial/Non-substantive change request for:

Cancer Trials Support Unit (CTSU) Customer Satisfaction Surveys (NCI).

OMB #0925-0624, Expiration Date: 12/31/2013

This is a request for OMB to approve a nonmaterial/non-substantive change to the Cancer Trials Support Unit program. CTSU initially received approval on 12/30/2010, and a non-substantive change request was approved for modifications to administrative forms on 8/26/2011. CTSU also collects surveys of customer satisfaction for clinical site staff that utilize the CTSU Help Desk and the CTSU web site. These surveys were approved in the initial submission and this request is to add three questions to the survey. The addition of these questions will not change the purpose, objectives of the program or to the estimated usage.

The Cancer Trials Support Unit (CTSU) is a contractor operated service offered by the National Cancer Institute - Cancer Therapy Evaluation Program (CTEP) - to enhance and facilitate access to cancer clinical trials in the United States and Canada. The CTSU maintains a broad menu of trials developed by the cancer Cooperative Groups and other research consortia and works with these organizations to offer patient enrollment, data collection, data quality management, regulatory services and enrollment reimbursement services to clinical sites entering patients in these trials. Westat is the prime contractor for this project.

User satisfaction surveys are compiled as part of the project quality assurance activities and are used to direct improvements to processes and technology. Although it is difficult to calculate the number of respondents and their frequency of responses, burden estimates are based on the average number of respondents from previous customer satisfaction surveys. It is estimated that the burden of usage will not change.

Three additional questions are being added to the web survey to measure the levels of satisfaction with specific functions of the CTSU website that have not been previously measured. New system integrations were recently completed which impact both the Oncology Patient Enrollment Network (OPEN) tab and Clinical Data tab of the CTSU website. There is a survey in place for the OPEN system but it does not address the informational page, known as the OPEN tab, on the CTSU website. These questions were not previously asked and are being added to obtain client feedback for further improvements.

Screenshots have been provided. As well, the web survey is being submitted with the yellow highlights indicating what and where the new questions will be located. Thanks for giving this your utmost consideration.

Attachments:

1: Survey showing new questions in yellow highlights

2: Screenshot of survey

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