2010-17038. Proposed Collection; Comment Request; Cancer Trials Support Unit (CTSU) Public Use Forms and Customer Satisfaction Surveys (NCI)

SUMMARY:

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Proposed Collection: Title: Cancer Trial Support Unit (CTSU). Type of Information Collection Request: Existing Collection in Use Without an OMB Number. Need and Use of Information Collection: CTSU collects annual surveys of customer satisfaction for clinical site staff using the CTSU Help Desk and the CTSU web site. An ongoing user satisfaction survey is in place for the Oncology Patient Enrollment Network (OPEN). User satisfaction surveys are compiled as part of the project quality assurance activities and are used to direct improvements to processes and technology. In addition, the CTSU collects standardized forms to process site regulatory information, changes to membership, patient enrollment data, and routing information for case report forms. This questionnaire adheres to The Public Health Service Act, Section 413 (42 U.S.C. 285a-2) authorizes CTEP to establish and support programs to facilitate the participation of qualified investigators on CTEP-supported studies, and to institute programs that minimize redundancy among grant and contract holders, thereby reducing overall cost of maintaining a robust treatment trials program.

Frequency of Response: The help desk and web site survey are collected annually. The OPEN survey is ongoing. Submission of forms varies depending on the purpose of the form and the activity of the local site.

Affected Public: CTSU's target audience is staff members at clinical sites and CTEP-supported programs. Respondent and burden estimates are listed in the Table below. The annualized burden is estimated to be 27,861 hours and the annualized cost to respondents is estimated to be $757,828. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

Attach No.	Section/form or survey title	Use metrics/ month—# respond	Estimated time for site to complete (minutes)	Estimated burden (minutes/ hours)	Frequency of response	Total annual usage/annual burden hours
1a	CTSU IRB/Regulatory Approval Transmittal Form	9,000	2	0.03	12.00	3,240
1b	CTSU IRB Certification Form	8,500	10	0.17	12.00	17,340
1c	CTSU Acknowledgement Form	500	5	0.08	12.00	480
1d	Optional Form 1—Withdrawal from Protocol Participation Form	10	5	0.08	12.00	10
Roster Forms:
1e	CTSU Roster Update Form	50	2-4	0.07	12.00	42
1f	CTSU Radiation Therapy Facilities Inventory Form	20	30	0.50	12.00	120
Drug shipment:
1g	CTSU IBCSG Drug Accountability Form	11	5-10	0.17	12.00	22
1h	CTSU IBCSG Transfer of Investigational Agent Form	3	20	0.33	12.00	12
Data Management:
1i	Site Initiated Data Update Form (generic)	10	5-10	0.17	12.00	20
1j	N0147 CTSU Data Transmittal Form	330	5-10	0.17	12.00	673
1k	Site Intimated Data Update Form (DUF), Protocol: NCCTG N0147*	30	5-10	0.17	12.00	61
1l	TAILORX/PACCT 1 CTSU Data Transmittal Form	1200	5-10	0.17	12.00	2,448
1m	Data Clarification Form	144	15-20	0.33	12.00	570
1n	Unsolicited Data Modification Form (UDM), Protocol:TAILORx/PACCT1	30	5-10	0.17	12.00	61
1o	Z4032 CTSU Data Transmittal Form	58	5-10	0.17	12.00	118
1p	Z1031 CTSU Data Transmittal Form	54	5-10	0.17	12.00	110
1q	Z1041 CTSU Data Transmittal Form	48	5-10	0.17	12.00	98
1r	Z6051 CTSU Data Transmittal Form	12	5-10	0.17	12.00	24
1s	RTOG 0834 CTSU Data Transmittal Form*	60	5-10	0.17	12.00	122
1t	CTSU 7868 Data Transmittal Form	30	5-10	0.17	12.00	61
1u	Site Initiated Data Update Form, protocol 7868	10	5-10	0.17	12.00	20
1v	MC0845(8233) CTSU Data Transmittal*	40	5-10	0.17	12.00	82
1w	8121 CTSU Data Transmittal Form*	40	5-10	0.17	12.00	82
1x	Site Initiated Data Update Form, Protocol 8121	10	5-10	0.17	12.00	20
1y	USMCI 8214/Z6091: CTSU Data Transmittal *In Development	50	5-10	0.17	12.00	102
1z	USMCI 8214/Z6091 Crossover Request/Checklist Transmittal Form	5	5-10	0.17	12.00	10
Patient Enrollment:
1aa	CTSU Patient Enrollment Transmittal Form	600	5-10	0.17	12.00	1,224
1bb	CTSU P2C Enrollment Transmittal Form	30	5-10	0.17	12.00	61
1cc	CTSU Transfer Form	40	5-10	0.17	12.00	82
Administrative:
1dd	CTSU System Account Request Form	10	15-20	0.33	12.00	40
1ee	CTSU Request for Clinical Brochure	35	10	0.17	12.00	71
1ff	CTSU Supply Request Form	130	5-10	0.17	12.00	265
Surveys/Web Forms:
2	CTSU Web Site Customer Satisfaction Survey	250	10-15	0.2500	1.00	63
3	CTSU Helpdesk Customer Satisfaction Survey	300	10-15	0.2500	1.00	75
4	CTSU OPEN Survey	120	10-15	0.2500	1.00	30
Annual Totals		21,770				27,861

Request for Comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Michael Montello, Pharm. D., CTEP, 6130 Executive Blvd., Rockville, MD 20852. At non-toll-free number 301-435-9206 or e-mail your request, including your address to: [e-mail].

Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.

Dated: July 7, 2010.

Vivian Horovitch-Kelley,

NCI Project Clearance Liaison, National Institutes of Health.