Ssb_cirb_11-13-2013

Supporting Statement B:

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

OMB No. 0925-0625, Expiry Date: 1/31/2014

November 2013

Revisions from the 2011 approved submission are highlighted in yellow.

Submitted by:

CAPT Michael Montello, Pharm. D., MBA

National Institutes of Health

National Cancer Institute

Cancer Therapy Evaluation Program (CTEP)

Operations and Informatics Branch (OIB)

BG 9609 RM 5W344

9609 Medical Center Drive

Rockville, MD 20850

(240) 276-6080

E-mail: [email protected]

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 2

B.4 Test of Procedures or Methods to be Undertaken 3

B.5 Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 3

List of Attachments

Attachment 1: CIRB Customer Satisfaction Survey

Attachment 1A: Email Invitation to Participate in Survey

Attachment 1B: Survey

Attachment 2: NCI CIRB Institution Enrollment Worksheet

Attachment 2A: Request for 30 Day NCI CIRB Website Access Form

Attachment 2B: Authorization Agreement / Division of Responsibilities between the NCI CIRB and the Signatory Institution

Attachment 2C: NCI CIRB Signatory Enrollment Form
Attachment 2D: IRB Staff at Signatory Institution’s IRB

Attachment 2E: Investigator at Signatory Institution

Attachment 2F: Research Staff at Signatory Institution

Attachment 2G: Investigator at Affiliate Institution with an IRB
Attachment 2H: Research Staff at Affiliate Institution with an IRB

Attachment 2I: Investigator at Affiliate Institution without an IRB
Attachment 2J: Research Staff at Affiliate Institution without an IRB

Attachment 2K: Institutional Contact for Signatory Institution

Attachment 2L: IRB at Signatory Institution

Attachment 2M: Component Institution at Signatory Institution

Attachment 2N: IRB at Affiliate Institution

Attachment 2O: Affiliate Institution without an IRB

Attachment 2P: Facilitated Review Acceptance Form

Attachment 2Q: Study Review Responsibility Transfer Form

Attachment 2R: Annual Institution Worksheet About Local Context

Attachment 2S: Annual Principal Investigator Worksheet About Local Context

Attachment 2T: Study-Specific Worksheet About Local Context

Attachment 2U: Study Closure or Transfer of Study Review Responsibility Form

Attachment 2V: Potential Unanticipated Problem or Serious or Continuing

Noncompliance Reporting Form

Attachment 2W: Add or Remove Signatory and/or Component Institution

Personnel

Attachment 2X: Add or Remove Affiliate Institution Personnel

Attachment 2Y: Add or Remove Component Institution

Attachment 2Z: Add or Remove Affiliate institution

Attachment 2ZA: One Time Study Roll Over Worksheet

Attachment 2ZB: Change of Signatory Institution PI Form

Attachment 3: CIRB New Board Member Orientation

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: NCI Adult/Pediatric CIRB Application for Treatment Studies

Attachment 5B: NCI Adult/Pediatric CIRB Application for Ancillary Studies

Attachment 5C: NCI Adult/Pediatric CIRB Application for Continuing Review

Attachment 5D: Summary of CIRB Application Revisions

Attachment 5E: Locally-Developed Material Submission Form

Attachment 5F: Application Request to Review Translated Documents

Attachment 6: CIRB Reviewer Worksheets

Attachment 6A: Adult Initial Review of Cooperative Group Protocol

Attachment 6B: Pediatric Initial Review of Cooperative Group Protocol
Attachment 6C: Adult Continuing Review of Cooperative Group Protocol

Attachment 6D: Pediatric Continuing Review of Cooperative Group Protocol

Attachment 6E: Adult Amendment of Cooperative Group Protocol

Attachment 6F: Pediatric Amendment of Cooperative Group Protocol

Attachment 6G: Adult Cooperative Group Response to CIRB Review

Attachment 6H: Pediatric Cooperative Group Response to CIRB Review Attachment 6I: Adult Pharmacist’s Review of a Cooperative Group Study

Attachment 6J: Pediatric Pharmacist’s Review of a Cooperative Group Study

Attachment 6K: CIRB Statistical Reviewer Form

Attachment 6L: Determination of Unanticipated Problem and/or Serious or Continuing Noncompliance

Attachment 6M: Adult Expedited Amendment Review

Attachment 6N: Ped Expedited Amendment Review

Attachment 6O: Adult Expedited Continuing Review

Attachment 6P: Ped Expedited Continuing Review

Attachment 6Q: Adult Expedited Closure

Attachment 6R: Ped Expedited Closure

Attachment 6S: Adult Expedited Study Chair Response to Required Mod

Attachment 6T: Ped Expedited Study Chair Response to Required Mod
Attachment 6U: Reviewer Worksheet of Translated Documents

Attachment 6V: Reviewer Advertisement Checklist

Attachment 7: Privacy Act Memo

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

Attachment 9: Privacy Impact Assessment (PIA)

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 has not changed since the previous OMB submission. All customers: public inquiry, member of Cooperative Group, National Clinical Trials Network (NCTN), the Early Therapeutics Clinical Trials Network (ET-CTN) submitting a request to the Helpdesk (via email or phone) will receive an email request to complete the survey if a valid email address is provided (Attachment 1A).

We receive approximately 335 helpdesk inquiries per month. This average is based on the total per month for one year (total received inquiries in one year: 4020) and dividing the total by # of associated months (4020/12 = 335). No sampling is performed: 100% of the people inquiring to the CIRB Operations helpdesk have the potential to be surveyed as long as a valid email address is provided. There is no consideration of other characteristics beyond inquiry and use of the services.

Since this is a voluntary survey, we receive approximately 55-65 completed surveys a month.  The surveys are anonymous.  They are completed online through SurveyMonkey.com.  We do not request any identifiable information on the customer completing the survey.

B.2 Procedures for the Collection of Information

The procedures for the collection of information with the CIRB Customer Satisfaction Survey (Attachment 1B) have not changed since the previous OMB Submission.

b. Rationale for Sample Size.

For the helpdesk surveys, an estimated 4020 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 25%.

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 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 Project Manager, Jennifer Dugan; and CIRB Quality Assurance Manager. The implementation team consists of the CIRB Outreach Coordinator, 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: [email protected]	Jennifer Dugan CIRB Project Manager EMMES Corporation Telephone: 301-251-1161 x2827 Email: [email protected]
Laura Covington CIRB Quality Assurance Manager EMMES Corporation Telephone: 301-251-1161 x2742 Email: [email protected]	Allison Peel CIRB Outreach Coordinator EMMES Corporation Telephone: 301-251-1161 x17411 Email: [email protected]
Diana Orr CIRB Outreach Specialist EMMES Corporation Telephone: 301-251-1161 x129 Email: [email protected]

viii