OMB Ssb_cirb_11-05-10

Supporting Statement B for:

NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI)

November 5, 2010

Mike Montello, Pharm. D.

NCI CIRB

National Cancer Institute

6130 Executive Blvd.

Rockville, MD 20852

Telephone: 301-435-9206

Fax: 301-402-0557

E-mail: montellom@mail.nih.gov

Table of Contents

B. STATISTICAL METHODS 1

B.1 Respondent Universe and Sampling Methods 1

B.2 Procedures for the Collection of Information 2

B.3 Methods to Maximize Response Rates and Deal with Nonresponse 5

B.4 Test of Procedures or Methods to be Undertaken 5

B.5 Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 5

List of Attachments

Attachment 1: CIRB Helpdesk Survey

Attachment 2: NCI CIRB Institution Enrollment Worksheet

Attachment 2A: CIRB Institution Enrollment Worksheet

Attachment 2B: IRB Staff at Signatory Institution’s IRB

Attachment 2C: Investigator at Signatory Institution

Attachment 2D: Research Staff at Signatory Institution

Attachment 2E: Investigator at Affiliate Institution

Attachment 2F: Research Staff at Affiliate Institution

Attachment 2G: IRB at Signatory Institution

Attachment 2H: Component Institution at Signatory Institution

Attachment 2I: IRB at Affiliate Institution

Attachment 2J: Affiliate Institution without an IRB

Attachment 2K: Request for 30 Day Website Access Form

Attachment 2L: Facilitated Review Acceptance Form

Attachment 2M: Study Review Responsibility Transfer Form

Attachment 3: CIRB New Board Member Orientation 2009

Attachment 3A: CIRB New Board Member Welcome Letter

Attachment 3B: CIRB Board Member Biographical Sketch Form

Attachment 3C: CIRB Board Member Contact Information Form

Attachment 3D: CIRB Board Member W-9

Attachment 3E: CIRB Board Member Non-Disclosure Agreement (NDA)

Attachment 3F: CIRB Board Member Orientation Steps

Attachment 3G: NCI’s Privacy Policy

Attachment 3H: CIRB Adult Query of Candidate Interest

Attachment 3I: CIRB Pediatric Query of Candidate Interest

Attachment 3J: Confirming Candidate Qualifications and Conflict of

Interest (COI) Statement

Attachment 3K: CIRB Notification of Selection to Serve on NCI CIRB

Attachment 3L: CIRB Notice of Rotation Off

Attachment 3M: CIRB Thank you to Retiring Members and Acknowledgement of Resignation

Attachment 3N: CIRB Internal Plaque Order Form

Attachment 3O: CIRB Operations New Member Checklist

Attachment 3P: CIRB Educational Checklist for Member File

Attachment 3Q: CIRB Operations Checklist for Retiring Board Members

Attachment 4: CIRB Direct Deposit Form

Attachment 5: CIRB Application Forms:

Attachment 5A: Adult CIRB Application

Attachment 5B: Pediatric CIRB Application

Attachment 5C: Adult/Pediatric CIRB Application - Ancillary Studies

Attachment 5D: Summary of CIRB Application Revisions

Attachment 5E: Adult/Pediatric CIRB Application for Continuing Review

Attachment 6: CIRB Reviewer Forms

Attachment 6A: Adult CIRB Reviewer Findings – Initial Review of

Cooperative Group Protocol

Attachment 6B: Pediatric CIRB Reviewer Findings - Initial Review of

Cooperative Group Protocol

Attachment 6C: Adult CIRB Reviewer Findings Cooperative Group

Response to CIRB Review

Attachment 6D: Pediatric CIRB Reviewer Findings Cooperative Group

Response to CIRB Review

Attachment 6E: Adult CIRB Reviewer Findings Amendment to

Cooperative Group Protocol

Attachment 6F: Pediatric CIRB Reviewer Findings Amendment to

Cooperative Group Protocol

Attachment 6G: Adult CIRB Reviewer Findings Continuing Review of

Cooperative Group Protocol

Attachment 6H: Pediatric CIRB Reviewer Findings Continuing Review of

Cooperative Group Protocol

Attachment 6I: CIRB Pharmacy Reviewer Form

Attachment 6J: CIRB Statistical Reviewer Form

Attachment 6K: CIRB SAE Reviewer Worksheet

Attachment 7: Privacy Act Memo

Attachment 8: Office of Human Subjects Research (OHSR) Determination

B. STATISTICAL METHODS

The Central Institutional Review Board (CIRB) collects one survey. The purpose of this survey is not statistical but rather an in-obtrusive way to determine customer satisfaction with CIRB Operations and to identify ways for improving service. This survey provides valuable input on customer satisfaction of CIRB Operations. Simple descriptive statistics are used to interpret results of survey.

B.1 Respondent Universe and Sampling Methods

The CIRB satisfaction survey was developed to collect customer feedback in an in-obtrusive way to improve customer service of the CIRB Helpdesk.  All customers (local site, member of Cooperative Group, public inquiry) submitting a request to the Helpdesk (via email or phone) will receive an email request to complete the survey if an email address is provided.  Having the survey available to all is necessary to ensure that every person that has contacted the Helpdesk has an opportunity to respond.

We receive approximately 140 helpdesk inquiries per month. This average is based on the total per month for one year (total received inquiries in one year: 1682) and dividing the total by # of associated months (1682/12 = 140). No sampling is performed: 100% of the people inquiring to the CIRB Operations helpdesk have the potential to be surveyed as long as there is a valid email address. There is no consideration of other characteristics beyond inquiry and use of the services.

Since this is a voluntary survey, we receive approximately 30-35 completed surveys a month.  The surveys are anonymous.  They are completed online through SurveyMonkey.com.  We do not collect any identifiable information on the customer completing the survey.

B.2 Procedures for the Collection of Information

CIRB Helpdesk Survey (Attachment 1) is an ongoing, electronic generated survey sent via email in response to CIRB Helpdesk inquiries. The Helpdesk Survey has 3 core questions used quantitatively over time to demonstrate trends in user satisfaction. Other questions are used to poll suggestions for improvement to operations. Questions are kept to a minimum to decrease the time necessary to complete the survey and to encourage response rate.

The project team conducts a formal meeting to develop the survey questions. The survey questions fall into three general categories of satisfaction: time, completeness of response, and overall interaction. The survey is made up of 3 multiple choice questions. One of the multiple choice questions includes an additional free text field for providing open comments. One question is purely open text requesting recommendations on how customer service could be improved.

To avoid bias, there is no attempt to stratify users. Several methods are used to obtain objective results:

• To avoid sampling bias, all customers inquiring to the helpdesk have the potential to receive a survey questionnaire as long as a valid email address is available

• Identification of individual respondents is withheld from the staff involved in the service being surveyed

• To avoid interpretation of single survey results, trends are measured over time

• Whenever possible, a core set of satisfaction measures are used over time

• Customers are provided opportunity for open-ended responses

Survey notifications are sent by e-mail, and include instructions for completion as well as a hyperlink to the survey. The survey is deployed using SurveyMonkey.com, an online survey system. All information collected is related to user experience with CIRB Operations services. No identifying information is collected in the survey and no questions of a sensitive nature are asked in the survey. E-mail information is not used within analysis of survey response.

Following survey deployment, the project team reviews the survey data on a monthly basis to identify recommendations for continuous improvement activities. Analysis tools such as fishbone diagrams, flow charts and graphs are used to compare relationships to activities and operations of the CIRB. This process includes identifying:

• Time

• Completeness

• Overall interaction

• Opportunities for improvement and priority recommendations

Survey results for all multiple choice questions are categorized as “very satisfied”, “satisfied”, and “not satisfied.” Results are compared across surveys to show general customer satisfaction trends. In addition, free text comments are reviewed and categorized by area, when appropriate. Often comments are related to other CIRB processes and these are shared with the team members from the appropriate task area. The quality assurance/quality control specialist drafts survey findings using a template graph and results are reported within the Monthly Progress Report. The results are reviewed and discussed internally and with program team.

b. Rationale for Sample Size.

For the helpdesk surveys, an estimated1500 people are polled on a yearly basis from the customer service base. These participants are selected because they contacted the CIRB Operations Helpdesk. Of the accumulative number of participants that contact the helpdesk annually, the response rates from the surveys generated is generally less 30%.

3. Quality Control.

The contractor follows an internal process developed for the NCI CIRB Helpdesk Surveys. This process includes monitoring the survey responses, response rates, and completeness of acquired data. These processes are reviewed annually, and staff is trained on procedures in their work areas.

B.3 Methods to Maximize Response Rates and Deal with Nonresponse

The purpose of this survey is not statistical but rather an in-obtrusive way to determine customer satisfaction with CIRB Operations and identify ways for improving service. Expected response rates are approximately 15 to 25%. The number of questions asked is kept to a minimum to limit the time needed to complete the survey and encourage response. In addition, most of the responses to questions are in multiple choice format; therefore, minimizing time needed to respond. No follow-up is completed for non respondents.

B.4 Test of Procedures or Methods to be Undertaken

Surveys are distributed to a small number of staff for review prior to distribution to the target population. Previous contact with population indicates that they are willing to answer questions regarding customer satisfaction. The Short Questionnaire consists of a limited number of questions. No pre-test or sampling is completed for the surveys.

B.5 Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

No consultations with persons outside of the NCI CIRB contracting team or the contractor have been made for the purposes of the survey. The survey team is lead by the CIRB PI, Claudine Valmonte; CIRB Director of Operations, Bianca Collins; and the CIRB Quality Assurance Manager, Laura Covington. The implementation team consists of the CIRB Project Manager, CIRB Outreach Specialist, the CIRB Helpdesk Coordinator, and other CIRB staff members as assigned.

Claudine Valmonte CIRB Principal Investigator EMMES Corporation Telephone: 301-251-1161 x214 Email: cvalmonte@emmes.com	Bianca Collins CIRB Director of Operations EMMES Corporation Telephone: 301-251-1161 x2855 Email: bcollins@emmes.com
Jennifer Dugan CIRB Project Manager EMMES Corporation Telephone: 301-251-1161 x2827 Email: jdugan@emmes.com	Laura Covington CIRB Quality Assurance Manager EMMES Corporation Telephone: 301-251-1161 x2742 Email: lcovington@emmes.com
Diana Orr CIRB Outreach Specialist EMMES Corporation Telephone: 301-251-1161 x129 Email: dorr@emmes.com

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