Scientific Review Committee

POLICIES and PROCEDURES
Fred & Pamela Buffett Cancer Center

First Edition: Version 1.0, September 26, 2003

Revised: Version 2.0, August 12, 2004

Version 3.0, February 23, 2005

Version 3.1, August 31, 2005

Version 3.2, December 23, 2005

Version 4.0, February 15, 2006

Version 4.1, March 13, 2006

Version 4.2, August 8, 2008

Version 5.0, January 29, 2009

Version 5.1, October 6, 2009

Version 5.2, November 4, 2009

Version 6.0, December 30, 2009

Version 6.1, January 11, 2010

Version 6.2, July 9, 2010

Version 6.3, September 15, 2011

Version 7.0, December 15, 2011

Version 7.1, July 10, 2012

Version 8.0, October 8, 2012

Version 9.0, March 10, 2014

Version 9.1, June 01, 2014

Version 10.0, December 14, 2015

Version 11.0, January 23, 2017

CONTACT INFORMATION

ASSOCIATE DIRECTOR for CLINICAL RESEARCH

Apar Ganti, M.D.

PRMS SCIENTIFIC REVIEW COMMITTEE (SRC)

Gregory Bociek, M.D., Chair

Justin Mott, M.D., Ph.D., Vice-Chair

SCIENTIFIC REVIEW COMMITTEE MEMBERS

Fred & Pamela Buffett Cancer Center SRC Policies and Procedures

Version 11.0, January 23, 2017

Janina Baranowska-Kortylewicz, Ph.D.

Vijaya Bhatt, M.D.

Adrian Black, Ph.D.

Don Coulter, M.D.

Nicole de Rosa, M.D.

Krishna Gundabolu, MBBS

Gleb Haynatzki, Ph.D.

David Kelly, Ph.D.

Jairam Krishnamurthy, M.D.

Rudy Lackner, M.D.

James D. Landmark, M.D.

Chi Lin, M.D.

Quan Ly, M.D.

Timothy R. McGuire, Pharm.D.

Aru Panwar, M.D.

Gail Paulsen, IRB

Jane Rips

Carol Russell

Karen Schumacher, Ph.D.

Yuri Sheinin, M.D., Ph.D.

Lynette Smith, Ph.D.

Gary Yee, Pharm.D.

Fang Yu, Ph.D.

Fred & Pamela Buffett Cancer Center SRC Policies and Procedures

Version 11.0, January 23, 2017

PRMS STAFF

Fred & Pamela Buffett Cancer Center SRC Policies and Procedures

Version 11.0, January 23, 2017

Anna Grant, RRT

PRMS/CPDMU Administrator

Eppley Institute 3009 A

(402) 559-4232 office

(402) 559-4970 fax

Kara Grau, RRT, MS

Regulatory Specialist/Auditor

Eppley Institute 3009 B

(402) 559-4935 office

(402) 559-4970 fax

TBA

Regulatory Data Associate

Eppley Institute 3009 B

(402) 559-4969 office

(402) 559-4970 fax

Fred & Pamela Buffett Cancer Center SRC Policies and Procedures

Version 11.0, January 23, 2017

PRMS/CPDMU OFFICE WEBSITE

SEARCHABLE WEBSITE OF ACTIVE CLINICAL TRIALS

Major Changes from Version 10 dated 11/30/15 to Version 11 dated 01/23/17

  1. Updated member list.
  2. Added clarifications regarding review process: See Section 1.B.
  3. Updated language regarding exempt review:See Section I.C, and II.B.1.b.
  4. Added job responsibility to PRMS Administrator: I.F.3
  5. Added a section regarding subcommittee review: II.A
  6. Updated language regarding review of multi-site trials based on guidance from p30:See section II.B.1.a, VI.1.b and VI.1.c.
  7. Updated PRMS email address: Throughout document.
  8. Added New Protocol Review Flowsheet: See Figure 1.
  9. Added the Requirement of acknowledgement from Disease Teams for New Protocols: See Section II.C.1.
  10. Further developed Prioritization: See Section IV.
  11. Added Decline to Review for Submissions: See Section VI.B.1.g and VI.B.2.g.
  12. Signature Authority for the PRMS Administrator added: See Section VII.
  13. Further Detail added for Response Deadlines: See Section VIII.
  14. Further Detail added for Study Closure: See Section IX.E.
  15. Low Accrual Policy with Appeal Process: See Section IX.F and Figure 2.

Major Changes from Version 9.1 dated 06/01/2014 to Version 10 dated 11/30/15

  1. Updated Formatting Throughout Document.
  2. Updated Member and Staff List: See Cover Page.
  3. Updated PRMS and Searchable Trials Websites throughout document.
  4. Removal of Language Regarding Campus Mail Submissions to the PRMS Office throughout document, and addition of SRC email address.
  5. Additional Examples of Studies that Do and Do Not Require SRC Review: See Section I.B, Page 1.
  6. Changes to National Cooperative Group Reviews: See Section B.2 Continuing Reviews,
  7. Change from Nebraska Medical Center (NMC) to Nebraska Medicine(NM): throughout document
  8. Abbreviation of Fred & Pamela Buffett Cancer Center to FPBCC: throughout document
  9. Change to CTRP Accrual Reporting for Participating Sites: See Section IX.B.2, Page 24.
  10. Mention Revised Submission Forms and Reviewer Sheets – Integration with RSS
  11. Addition of organizational chart
  12. Addition of Language Regarding Disease-focused Oncology Teams (DOTs) in the prioritization of trials: See Section IV. Prioritization, Page 12 of 31.

SCIENTIFIC REVIEW COMMITTEE

ADMINISTRATIVE POLICIES AND PROCEDURES5

PURPOSE5

CANCER RELATED STUDIES THAT REQUIRE REVIEW BY THE SRC COMMITTEE5

CANCER RELATED STUDIES THAT MAY BE REVIEWED ADMINISTRATIVELY5

FINAL DETERMINATION OF NEED FOR SRC REVIEW6

MEETING SCHEDULE6

MEMBERSHIP6

Appointment Terms6

Voting and Non-voting Members6

Roles and Responsibilities6

Chair7

Vice Chair7

PRMS Administrator7

PRMS Office7

Current Members7

Quorum7

PROTOCOL SUBMISSIONS7

SUBMISSION DEADLINES7

TYPES OF SUBMISSIONS8

New Protocol8

Full Committee8

Accelerated (Administrative) Review8

Exempt from Further SRC Review9

Continuing Review11

Change(s) in Protocol11

SUBMISSION REQUIREMENTS11

New Protocol11

Investigator-Initiated Institutional Protocols and Multi-Institutional

Protocols Sponsored by UNMC 11

Multi-Institutional Protocols Not Sponsored by UNMC, National Cooperative

Group, Industrial and Other Externally Peer Reviewed Protocols12

Intervention Pilot Protocols12

Non-Intervention Pilot Protocols12

Non-Intervention Protocols12

Studies That Are Partially Cancer Related13

Continuing Review13

Request for Change13

PROTOCOL CLASSIFICATION SYSTEMS AND DEFINITIONS13

NCI STUDY SOURCE CLASSIFICATIONS (i.e. sponsor)14

Institutional Trials14

Investigator-Initiated Institutional Protocols14

Multi-Institutional Protocols14

Other Externally Peer Reviewed (OEPR) Institutional Trials14

National Cooperative Group Trials14

Industrial Trials14

Other Externally Peer Reviewed (OEPR) Non-Institutional Trials15

NCI PRIMARY PURPOSE CLASSIFICATIONS15

Intervention Trials15

Treatment Intervention Trials15

Prevention Intervention Trials15

Other Intervention Trials15

Non-Intervention Trials 15

Ancillary Trials15

Correlative Trials16

Observational Trials16

NCI STUDY PHASE CLASSIFICATION16

Pilot or Feasibility Intervention Studies16

Phase 0 Intervention Studies16

Phase 1 Intervention Studies16

Phase 2 Intervention Studies16

Phase 3 Intervention Studies 16

Phase 4 Intervention Studies 16

Combination Phase Intervention Studies 17

Compassionate Use, Expanded Access, or Single Patient Access

Intervention Studies17

NCI STUDY TYPE CLASSIFICATION17

Basic Science Trials17

Diagnostic Trials17

Health Service Research Trials17

Screening Trials17

Supportive Care Trials17

Other Non-Intervention Trials17

PRIORITIZATION17

OTHER REQUIREMENTS18

PROTOCOL REVIEW PROCEDURES18

SRC PROTOCOL REVIEW PROCEDURES18

Assignment of Reviewers18

Types of Reviews 19

Reviewer Responsibilities20

Changes to the Protocol 21

Continuing Reviews22

Continuing Review with Request for Change22

REVIEW OUTCOMES 22

New Protocol and Continuing Reviews22

Request for Change Reviews23

VOTING PROCEDURES23

REPORTING RESULTS OF SRC REVIEW23

DEADLINE FOR PI RESPONSE24

REPORTING REQUIREMENTS24

ACCRUAL REPORTING24

ACCRUAL REPORTING FOR STUDIES THAT ARE NOT ENTIRELY

CANCER RELATED 24

FINAL SRC REVIEW and STUDY COMPLETION24

STUDY TERMINATION or WITHDRAWAL BY THE PRINCIPAL INVESTIGATOR (PI)25

STUDY TERMINATION BY THE SRC25

STUDY CLOSURE FOR INSUFFICIENT ACCRUAL25

TOXICITY AND ADVERSE EVENTS REPORTING TO THE DSMC27

ADHERENCE REPORTING TO THE AUDIT COMMITTEE28

CLINICAL TRIALS REPORTING PROGRAM (CTRP)28

PRIMARY RESPONSIBILITY FOR CTRP REGISTRATION29

Institutional Trials29

National Cooperative Group Trials29

Industrial Trials29

Other Externally Peer Reviewed Trials29

QUARTERLY ACCRUAL REPORTING TO CTRP29

Subjects Registered at UNMC and at UNMC’s Associated Locations29

Subjects Registered at Participating Sites30

Quarterly Accrual Verification31

CTRP REGISTRATION DEADLINES for INSTITUTIONAL TRIALS31

New Protocols31

Protocol Amendments31

Study Updates31

Status Changes31

Reporting Subjects Registered at Participating Sites 31

CTRP REGISTRATION DEADLINES FOR INDUSTRIAL TRIALS31

CTRP REGISTRATION DEADLINES for NATIONAL COOPERATIVE GROUP TRIALS

andOTHER EXTERNALLY PEER REVIEWED TRIALS 31

COMPLIANCE w/ CTRP REGISTRATION and ACCRUAL REPORTING

REQUIREMENTS32

Written Notification of PI’s Responsibilities

Compliance Monitoring by the PRMS Office32

Referral of Non-Compliance to the SRC32

Corrective Action Plan32

Right to Appeal32

LINK TO CTRP USER’S GUIDES32

APPENDIX D.1: FRED & PAMELA BUFFETT CANCER CENTER SRC PROTOCOL FORMAT33

APPENDIX D.2: SRC SUBMISSION REQUIREMENTS40

SCIENTIFIC REVIEW COMMITTEE

I.ADMINISTRATIVE POLICIES AND PROCEDURES

A.PURPOSE

A functioning Scientific Review Committee (SRC) is a mandatory element of a National Cancer Institute (NCI) designated clinical cancer center. The SRC oversees the scientific aspects of cancer-related research involving human subjects conducted by members of the University of Nebraska Medical Center (UNMC) faculty and students, and members of the Fred & Pamela Buffett Cancer Center (FPBCC). The SRC facilitates the development of innovative, collaborative, and scientifically sound studies that focus on the prevention, detection, diagnosis, and treatment of cancer and its long-term follow-up and care. The SRC helps investigators to prioritize studies to ensure optimal allocation of FBPCC resources. The SRC review process also mentors and guides inexperienced investigators in the development of research proposals that will result in scientifically sound outcomes.

B.CANCER RELATED STUDIES THAT REQUIRE REVIEW BY THE SRC COMMITTEE

All new submissions to the SRC are triaged by the PRMS Administrator and processed according to the committee’s new protocol review process (fig. 1 p 10). In addition, trials that meet the SRC criteria for “exempt from further review”along with minor personnel changes that do not include a change in the PIare approved and released by the PRMS Administrator. Any trial that falls outside of the criteria outlined in section II.B.1.b below will be screened by the SRC Chair.All cancer-related studies involving human subjects or material of human origin for which the investigator directly interacts with human subjects are considered “clinical research” by the NCI and require SRC review. Examples of clinical research studies that require SRC review include the following:

  • Studies that require consent of human subjects and/or involve cancer patients;
  • Studies that have as a principal investigator a UNMC faculty member or a FPBCC member;
  • Treatment or therapeutic intervention studies involving agents or medical devices for cancer management;
  • Late effects and quality of life studies;
  • Studies to develop new technology related to diagnosis or disease management;
  • Laboratory studies of the mechanism of human disease that maintain identifiers or involve previously banked tissues connected to subjects by identifiers;
  • Studies that investigate cancer etiology, prevention, or control;
  • Studies that investigate secondary cancer prevention, symptom management during and following treatment, and survivorship;
  • Studies that investigate cancer risk factors (e.g., dietary studies, studies that involve surrogate endpoints such as precancerous lesions, polyps for colon cancer, genetic markers, and interventions for cancer prevention);
  • Studies that require consent of human subjects that address the specific effects of a cancer diagnosis or its related treatments on family members and/or healthy controls if they are matched or dyadic with cancer patients;
  • Prospective, hypothesis-driven chart review studies.

C.CANCER RELATED STUDIES THAT MAY BE REVIEWED ADMINISTRATIVELY

  • Database infrastructure and tissue banking studies;
  • Cancer Control, Quality of Life (QOL), and prevention, screening, or detection studies involving healthy subjects that do not have cancer as a disease end-point or outcome;
  • Studies that involve the promotion of a healthy lifestyle in healthy subjects without a cancer endpoint;
  • in vitro studies utilizing human tissues that cannot be linked to a living individual;
  • Studies that do not require patient consent;
  • Studies that require a one-time emergency IRB approval to treat a specific cancer patient.

D.FINAL DETERMINATION OF NEED FOR SRC REVIEW

When a Principal Investigator believes a study does not fall within the purview of the SRC, the PI may submit a completed IRB application only and request that a preliminary review be conducted by the SRC Chair. If a determination is made that the study does not require full SRC review, this decision must be confirmed by the entire SRC at the next regularly scheduled meeting. The IRB review continues to be required.

Questions regarding need for SRC review can be directed to the FPBCC Protocol Review and Monitoring System (PRMS) Administrator at (402) 559-4232. Final determination of whether or not a study requires SRC review will be made by the SRC.

E.MEETING SCHEDULE

SRC meetings are held on the second Monday of each month. A list of scheduled meetings and SRC submission deadlines is available from the FPBCC PRMS office, (402) 559-4969, via ,or on the PRMS website at Criteria for consideration of accelerated/urgent SRC subcommittee review may be found in section II.A.

F.MEMBERSHIP

1.Appointment Terms: Members are appointed for three year terms that can be renewed at the discretion of the SRC Chair. All SRC members receive an orientation to the SRC and a copy of the SRC Policies and Procedures manual.

2.Voting and Non-voting Members: SRC members are appointed by the FPBCC Director. Voting members include one biostatistician, one community member, and representatives of academic units/departments. Non-voting members include an IRB representative and the PRMS Administrator. At large or additional ad hoc members may be appointed or asked to review submissions in situations where the required specific expertise is not already present on the SRC for a particular content area. Academic units include, but are not limited to the following:

Fred & Pamela Buffett Cancer Center SRC Policies and Procedures

Version 10.0, November 30, 2014

Page 1 of 40

  • Adult Oncology/Hematology
  • College of Nursing
  • College of Pharmacy
  • Eppley Institute for Research in Cancer

Fred & Pamela Buffett Cancer Center SRC Policies and Procedures

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Page 1 of 40

  • Head and Neck Surgery/Otolaryngology
  • Biostatistics
  • Pathology/Microbiology
  • Pediatric Oncology/Hematology
  • Radiation Oncology
  • Surgery/Surgical Oncology

Fred & Pamela Buffett Cancer Center SRC Policies and Procedures

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Page 1 of 40

3.Roles and Responsibilities:

Chair

  • Appointed by the FPBCC Director;
  • Chairs monthly SRC meetings;
  • Corresponds with investigators;
  • Orients new members to SRC policies and procedures;
  • Reports to the Associate Director for Clinical Research, Director of the FPBCC and the Chancellor of UNMC.

Vice-Chair

  • Voting member of the SRC appointed by the Chair;
  • Assumes the Chair’s duties as needed;
  • Reports to the Chair of the SRC.

PRMS Administrator

  • Reviews and releases new research proposals for studies eligible for exempt status as defined in Figure 1.
  • Reviews and approves minor personnel changes other than a change in the PI.

PRMS Office

  • Assigns reviews to committee members;
  • Records meeting minutes;
  • Generates correspondence to investigators following the SRC’s review;
  • Maintains data on studies reviewed by the SRC;
  • Generates protocol and accrual reports;
  • Assists investigators in preparing submissions;
  • Ensures adherence of protocol submission formats and supporting documentation;
  • Maintains data on subject accrual;
  • Maintains the data in the PRMS database;
  • Participates in new study coordinator training;
  • Obtains annual feedback on the SRC Policies and Procedures from SRC members, PIs and study coordinators;
  • Consults on the design and revisions of the PRMS website;
  • Ensures that a copy of the current SRC Policies and Procedures are available at all SRC meetings;
  • Reports to the Associate Director for Clinical Research and to the Director of the FPBCC.

4.Current Members:A list of current members is available in the PRMS Office.

5.Quorum:The number of SRC members required to be present at any regularly scheduled SRC meeting in order to transact business shall be six (6) members. Those present must include at least: 1) the Chair, Vice Chair or their designee; 2) two (2) M.D.’s.; 3) two (2) Ph.D’s.; and 4) one (1) statistician or ad hoc statistical at large member.

II.PROTOCOL SUBMISSION

A.SUBMISSION DEADLINES

The SRC submission deadline is the 4th Friday of every month, unless otherwise noted on the list of scheduled meetings and SRC submission deadlines. A list of scheduled meetings and SRC submission deadlines is available from the FPBCC PRMS office or on the PRMS Website at

Submissions to the SRC should be made directly to the PRMS Office (ECI, Room 3009A), or to .

Subcommittee Review:

The SRC meets once a month and has no provision for reviewing protocols that are submitted beyond the regular deadlines. If an investigator believes one of the conditions below applies to the submission the investigator may request that a Subcommittee of the SRC review new protocols or changes to a previously approved protocol (see SRC Section VI.A.2.) To be eligible for a subcommittee reviewone of the following conditions must apply:

  1. The study source (i.e. sponsor) or funding agency’s deadline is such that consideration at a regularly scheduled SRC meeting would not be feasible given the time constraints; and the study represents an important research venture for the PI UNMC, or involves an important/urgent treatment option for patients.
  2. The proposed protocol change(s) involves an important treatment option for a potential patient already identified by the investigator and directly affects that patient’s ability to begin treatment as outlined in the protocol.
  3. The study is a single subject compassionate use protocol.

Although the subcommittee may grant approval to the investigator, the decision must be confirmed by the entire SRC at the following meeting. The IRB review remains required.

B.TYPES OF SUBMISSIONS

1.New Protocol: Any new cancer-related clinical research study that is cancer-related involving human subjects. Fig 1 summarizes the process of how the SRC makes a determination of the need for protocol review and type/level of review (i.e., full board review, Accelerated {Administrative} review, exempt from further review).

  • New protocol submission requirements are defined in SRC Section II.C.1.
  • See SRC Section I.B for what constitutes a cancer-related clinical research study.
  • See Appendix D.2 for a bulleted list of SRC new protocol submission requirements by SRC classification.
  • See SRC Section C.1 for protocol sub-type descriptions
  • See SRC Section VI. A. 2 for types of reviews.
  • See Appendix D.1 for directions on creating a protocol in FPBCC SRC Protocol Format

NOTE: Protocols in FPBCC Center SRC format are required for the following types of submissions:

  • Investigator-Initiated Institutional Intervention studies (treatment intervention, prevention intervention, or other intervention trials)
  • Multi-Institutional Intervention studies (treatment intervention, prevention intervention, or other intervention trials) with UNMC as the sponsor
  • Institutional, Ancillary and Companion studies that are Investigator Initiated (i.e. written by a local PI with UNMC as the sponsor)
  • Interventional Pilot studies
  • Full Committee Protocol Review: Protocols which will require full committee protocol review include Investigator-Initiated Institutional Protocols, Multi-Institution Protocols Sponsored by UNMC, and Industrial Protocols.
  • Accelerated (Administrative) Review: All cancer-related protocols require initial review by the SRC to determine whether or not ongoing SRC review is necessary.

While the full SRC is ultimately responsible for deciding whether a study requires ongoing SRC review, investigators may ask the SRC Chair or his/her designee to conduct an Accelerated(Administrative) Review, which will be presented to the full SRC at its next regularly scheduled meeting for confirmation. Accelerated reviews will focus on prioritization and the feasibility of conducting the proposed research at UNMC. Some examples of such research include:

  • CIRB approved NCG studies
  • Multi-Institutional studies where UNMC is not the sponsor

Investigators who believe that their research qualifies for SRC Accelerated (Administrative) Review should begin by submitting only a copy of the completed IRB application to the SRC for review.