#8_Justif Memo_PIO CTEP

Date: December 14, 2010

To: Office of Management and Budget (OMB)

Through: Seleda Perryman, DHHS Report Clearance Officer

Mikia Currie, Program Analyst, NIH Project Clearance Branch, OPERA

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

From: Steve Friedman, Branch Chief, Operations and Infomatics Branch,

Cancer Therapy Evaluation Program (CTEP), and

National Cancer Institute (NCI)/NIH

Nina Goodman, Project Officer,

Office of Communications and Education,

National Cancer Institute (NCI)/NIH

Subject: Bundled Generic Sub-studies under “Formative Research, Pretesting, and Customer Satisfaction of NCI’s Office of Communications and Education”, OMB No. 0925-0046, Expiry Date 02/28/2013

Sub-Study #8, “Protocol and Information Office External Customer Satisfaction Survey,” Proposed OMB No. 0925-0046-08

Background, Need and Use of Information

The Cancer Therapy Evaluation Program (CTEP)'s Operations and Informatics Branch serves to improve the protocol development and conduct processes through the use of efficient business practices and informatics tools within the Division of Cancer Treatment and Diagnosis at the National Cancer Institute (http://ctep.cancer.gov/branches/pio/default.htm). The creation of OIB in 2008 brought together the operations hub and informatics strength of the Protocol and Information Office (PIO) and the CTEP Enterprise System in one organization. The PIO collects, processes, tracks and monitors all protocol related information between CTEP and its extramural collaborators as well as with other CTEP and NCI programs. The purpose of the Protocol and Information Office is to facilitate the development of quality clinical trials in the most efficient and expeditious manner possible and to relieve the administrative burden related to clinical trial development and management on CTEP staff and the extramural community.

This request is for an external customer satisfaction survey that will assess the PIO’s performance. PIO is made up of contractors serving customers internal and external to the NCI. The request for an external customer satisfaction survey is a contract requirement and is intended to occur on an annual basis. The results and findings from this survey will further help NCI ensure the relevance, utility, and appropriateness of the many services and tasks that the PIO performs for the external customers who collaborate with CTEP to conduct CTEP sponsored clinical trials. The results of the survey will be evaluated by the Chief of the Operations and Informatics Branch, the Head of PIO (staff in OIB), PIO contract leadership, and NCI contracts as part of the assessment of contract deliverables and awarding of performance fee if applicable.

Participants

The survey will be sent out to all clinical trial site personnel captured in the CTEP Enterprise database which amount to an estimated 600 individuals over three years. The survey is sent via email by PIO. It is anticipated that 80 customers will respond annually to the survey, which amounts to a total of 240 customers over a three-year period.

Methodology

A letter is sent to clinical trial site personnel listed in the CTEP Enterprise database to include principle investigators, site coordinators, and operation center personnel (see Attachment 8B). This includes the vast majority of external personnel that the CTEP PIO interacts with. The letter is sent by email and references the survey tool which also includes a website and login information. PIO sends the survey out to all external personnel listed in the database is due to the fact that interactions can vary greatly between organizations and type of personnel and a sampling of personnel would not provide the full potential range of feedback necessary to use for process and customer service improvements. The intent and contract requirement of the PIO is to send the survey out annually.

Respondents are encouraged to complete the survey and the email letter includes a completion date, typically 15-30 days from the date the survey is sent out. Since the survey is a web based tool, the software utilized will automatically collect responses and will allow report generation and sorting of responses to further analyze the feedback collected in the survey tool. Results are not made public but are shared internal to the NCI with personnel such as the PIO Project Officer, Head of PIO, CTEP Associate Director, CTEP Branch Chiefs and NCI contracts office.

Research Instrument

The survey is made up of 5 general questions asking respondents to answer using a 10 point scale (see Attachment 8A). There is also a free text field to enter general comments. The survey will only collect NCI affiliation and the email address used as a username to log into the survey. The general categories include a list of all of the contracted Cooperative Groups as well as a category of “Other” where respondents can fill in another organization. As the majority of the PIO interactions with external customers are Cooperative Groups, the ability to track the volume of responses from the Groups was important for feedback assessment.

The information that will be collected is related to the respondents’ perception of the service, professionalism, timeliness, and knowledge provided by PIO staff. Respondents will receive an email letter from PIO (see Attachment 8B) that will include a link to the survey and will use their work email address to serve as a username to access the survey.

The information will be collected and assessed by PIO contract staff as well as the government personnel overseeing the contract which includes the Head of PIO and the Chief of the Clinical Trials Operations and Informatics Branch. The survey will be analyzed using descriptive statistics for the scaled items and theme analysis to quantify the comments. The results will be used to assess any gaps in performance by PIO as well as identify areas of process improvement that can come to light during the survey process. The results may indicate that PIO needs to improve how it communicates to and with external stakeholders. It may also reveal the need to conduct a training session on information or processes that cause ongoing issues. The results are also used to score this related measure in the PIO Quality Assurance Surveillance Plan (QASP). The QASP is a 22 measure performance plan which assesses PIO performance in areas of timeliness and quality. The PIO Survey helps verify areas of high quality performance and areas for improvement as identified by the external stakeholders.

Other Considerations

No personally identifiable information is collected.

Burden

The survey should take each of the participants approximately 10 minutes (.16 hour) to complete. It is anticipated that 80 customers will respond annually to the survey, which amounts to a total of 240 customers over a three-year period. The total respondent burden for this effort is estimated to be 40 hours over the three-year data collection period. The total burden approved for this generic study was 7050 hours and this sub-study accounts for less than 1% of the burden hours for this package.

Estimates of Hour Burden and Respondent Cost Over a Three-Year Period
Types of Respondents	Number of Respondents	Frequency of Response	Average Time Per Response (Hours)	Total Hour Burden
Project Investigators, Clinical Staff	240	1	10/60 ( .167 )	40

Attachment (attached below):

8B. Email Letter to Respondents

Attachment (attached in a separate file):

8A. Protocol and Information Office Survey (word document version of web screens)

Attachment 8B: Email Letter to Respondents

To: [email protected]

Subject: NCI CTEP Protocol and Information Office (PIO) External Customer Satisfaction Survey

Dear Customer,

As someone who has worked with the National Cancer Institute (NCI), Cancer Therapy Evaluation Program (CTEP), Protocol and Information Office (PIO), we invite you to take a Customer Satisfaction Survey so that we may continue to meet your evolving needs.

This survey should take less than 10 minutes to complete and respondent information will be kept secure to the extent permitted by law.

 

Please click https://secure.cabezongroup.com/PQRS/ and enter the following login information: 

 

Email address: [email protected]

Password:      012345

Please be sure to complete the survey by MM/DD/YYYY. 

If you have any questions or concerns regarding this survey, please do not hesitate to contact me.  On behalf of PIO, thank you!

Peter Hmel - Program Manager

Cabezon Group Contractor for:

NCI CTEP Protocol and Information Office (PIO)

301-451-4471 direct

301-496-1367 main

http://ctep.cancer.gov

mailto:[email protected]

(signature will be included)

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