NOTE: All Changes from Previous Versions of This

NOTE: All changes from previous versions of this

form are highlighted in grey for your convenience.

NEW PROTOCOL SUBMISSION FORM

Instructions: Please complete and submit this form to the Fred & Pamela Buffett Cancer Center Protocol Review and Monitoring System (PRMS) Office (Campus Zip 6805) by the fourth Friday of each month. Submissions received after this deadline will be reviewed at the subsequent SRC meeting. NOTE: Due to the holidays, the submission deadline for November and December is the 3rd Friday of the month.

SECTION I: BASIC PROTOCOL DATA

Current IRB#:

Title:

Principal Investigator (PI):Phone: Email:

PI Dept.: PI Zip:

Study Coordinator/Contact: Phone: Email:

Data Coordinator/Contact: Phone: Email:

Statistician (if applicable):Phone: Email:

Is this a re-submission of a previously tabled protocol? YesNo

NOTE: Tabled protocols must be resubmitted in their entirety.

SECTION II: Check here if you believe this protocol qualifies for SRC ACCELERATEDREVIEW

NOTE: Many specimen studies, retrospectivemedical record reviews, and projects involving existing documents or records may qualify for “SRC Accelerated Review”. Some examples of SRC Accelerated Review research include:

Anonymous surveys and retrospective chart reviews;
Analysis of discarded pathological specimens without personal identifiers;
Proposals involving previously banked materials and/or tissues;
Protocols to obtain tissue or other biological samples for prospective or undetermined future research.

SECTION III: NCI STUDY SOURCECLASSIFICATION (i.e. sponsor) –Please select A1, A2, A3, B1, B2 OR B3 below as the sponsor classification that best matches this protocol.

A.INSTITUTIONAL TRIALS: Includes studies authored or co-authored by a local PI and studies authored by PIs at other institutions with a local PI participating. Please select A1 OR A2 below to indicate if the study is an Investigator-Initiated Institutionaltrial OR a Multi-Institutional trial.

A1. INVESTIGATOR-INITIATED INSTITUTIONAL TRIAL: Protocol that has been designed and developed by a local investigatorwith UNMC as the sponsor. Protocol may be implemented only at UNMC and its1associated locationsor at multiple 2participatingclinical sites. Protocol may or may not have received external funding and may include collaborative studies conducted with industry in which the local PI is the primary contributor to the design, implementation and monitoring of the trial.

1NOTE: A UNMC/NMC associated location includes but is not limited to the Bellevue Medical Center, Village Pointe Medical Center, NE Orthopedic Hospital, and UNMC/NMC Clinics.This does not include Children’s Hospital and Medical Center.

2NOTE: The previous definitions of “Affiliate” and “Participating” sites are no longer valid. All sites other than UNMC/NMC and their associated locations are now considered “Participating” sites. This includes Children’s Hospital and Medical Center.

Investigator-InitiatedInstitutional Trial––Single-Site: Protocol sponsored by UNMC and being implemented by local PI only at UNMC/NMCand their 1associated locations.

Investigator-InitiatedInstitutional Trial––Multi-Site: Protocol sponsored by UNMC and being implemented by local PI at UNMC and their 1associated locations and at least one additional *participating site.

*Additional participating sites(s) where trial will be implemented:

If this is an Investigator-Initiated Institutional––Multi-site trial with UNMC serving as sponsor, please provide the following information:

Monitor for Study/Contact:(if other than the UNMC/NMC Study Coordinator)

Phone:Email:

Investigator-InitiatedInstitutional Trial––Industry-Supported: Protocol that is receiving some funding from industry but that is authored by a local PI.

Investigator-InitiatedInstitutional Trial––Grant-Funded: Protocol that has been externally peer reviewed for funding purposes only.

Grant Funding Source:

Grant Number: Anticipated Grant Submission Date:

A2. MULTI-INSTITUTIONAL TRIAL:Protocol in which a local PI is participating in a studythat is designed and developed at another institution. Although more than one IRB approval may be required for these protocols, UNMC is not serving as the sponsor of these trials.

Study Source (i.e. Sponsor or Lead Institution):

A3. OTHER EXTERNALLY PEER-REVIEWED INSTITUTIONAL TRIAL: R01, P01 or other trial funded by NIH or supported by other peer-reviewed funding organizations, but not listed under Section III.B3 below.

B.NON-INSTITUTIONAL TRIALS: Includes National Cooperative Group studies, studies not authored by a local PI, and studies authored and conducted by Industry. Please select B1, B2 OR B3 below to indicate if the study is a National Cooperative Group trial, Industry trial OR Other Externally Peer Reviewed trial.

B1. NATIONAL COOPERATIVE GROUP TRIAL: Protocol that is initiated by an NCI funded study group and receives CTEP review. NOTE: Only those study groups listed below qualify for this classification.

ALLIANCE Alliance for Clinical Trials in Oncology Foundation

ACRINAmerican College of Radiology Imaging

ACOSOGAmerican College of Surgeons Oncology Group

COG Children’s Oncology Group

ECOG Eastern Cooperative Oncology Group

EORTC European Organization for Research and Treatment of Cancer

GOGGynecologic Oncology Group

NCI CANational Cancer Institute of Canada, Clinical Trials Group

NSABPNational Surgical Adjuvant Breast and Bowel Project

NCCTGNorth Central Cancer Treatment Group

RTOGRadiation Therapy Oncology Group

SWOGSouthwest Oncology Group

Did you as investigator play a major role in the development of this protocol? No Yes

If yes, please explain your level of participation.

B2. INDUSTRIAL TRIAL: Protocol that is designed, developed and monitored by Industry.

Study Source (i.e.Sponsor):
Did you as investigator play a major role in the development of this protocol? No Yes

If YES, please explain your level of participation.

B3. OTHER EXTERNALLY PEER-REVIEWED NON-INSTITUTIONALTRIAL: R01, P01 or other trial funded by NIH or supported by other peer-reviewed funding organizations, such as the ACS, the Komen Foundation, Leukemia and Lymphoma Society, U.S. Army (DOD) etc. (For a complete list of NIH supported peer-reviewed organizations, please see

ACS American Cancer Society

AICR American Institute for Cancer Research

BMT/CTNBlood and Marrow Transplant Clinical Trials Network

CIRBNCI Central Institutional Review Board

DODDepartment of Defense

FDAFood and Drug Administration

KOMENSusan G. Komen for the Cure

LLS Leukemia and Lymphoma Society

MMRFMultiple Myeloma Research Foundation

VACentral Office of the Veterans Administration (excluding local/regional awards)

OtherPlease Specify

If Other, has this protocol been previously reviewed by the NCI’s Cancer Therapy Evaluation Program (CTEP) or Division of Cancer Prevention (DCP)? No Yes
Did you as investigator play a major role in the development of this protocol? No Yes

If YES, please explain your level of participation.

SECTION IV: NCIPRIMARY PURPOSE and PHASE (for intervention trials only)

DEFINITION OF INTERVENTION TRIALS: Clinical trial in which individuals are assigned to receive specific interventions by an investigator based on a protocol. The participants may receive diagnostic, therapeutic, behavioral or other types of interventions. The assignment of the intervention may or may not be random. The participants are followed and biomedical and/or health outcomes are assessed.

PRIMARY PURPOSE for all Intervention Trials:Please select either A1, A2 OR A3 below as the Primary Purpose for the trial.

A1. TREATMENT INTERVENTION TRIAL: Clinical trial designed to evaluate one or more interventions for treating a disease, syndrome, or condition. NOTE: This equates to “therapeutic” trials in previous NCI definitions.

A2. PREVENTION INTERVENTION TRIAL: Clinical trial designed to assess one or more interventions aimed at preventing the development of a specific disease or healthcondition using behavioral modification, nutrition, dietary or other interventions.

A3. OTHER INTERVENTION TRIAL: Clinical intervention trialthat does not meet the definition of treatment intervention or prevention intervention studies as described above.

PHASE: For all Intervention trials, whether Treatment Intervention, Prevention Intervention OR Other Intervention trial.Please select B1, B2, B3, B4, B5, B6, B7, OR B8 below as the PHASE for the trial.

B1.Pilot or Feasibility: Protocols where primary objective is to collect preliminary data to plan a future protocol. The trial must be limited in duration and the investigator must specify future plans.

B2.Phase 0: Exploratory trials involving very limited human exposure, therapeutic, or diagnostic intent (e.g. microdose studies).

B3.Phase 1: Protocols designed to determine a safe method/dose for Phase 2 trials and define acute effects that occur with a relatively high frequency in normal tissues.

B4.Phase 2: Protocols designed to a) determine whether a treatment/agent has anti-tumor activity and b) estimate the response rate in a defined patient population.

B5.Phase 3: Protocols designed to compare the new drug or treatment modality with standard treatment or observation, if no standard treatment exists.

B6.Phase 4: Protocols designed to evaluate side effects that were not apparent in Phase 3 trials after a treatment has been approved and is being marketed.

B7.Combination: Phase 1/2 Other: Please specify

B8.Compassionate Use, ExpandedAccess, or Single Patient Access Study

SECTION V: NCIPRIMARY PURPOSE and TYPE (for Non-Intervention trials only).

DEFINITION OF NON-INTERVENTION TRIAL:AnAncillary, Correlative or Observational trialusing clinical specimens that can be linked to individual patient or participant data.

PRIMARY PURPOSE for Non-Intervention Trials:Please select either A1, A2 OR A3 below as the Primary Purpose for the trial.

A1. ANCILLARY TRIAL: Study that is stimulated by, but not a required part of, a main clinical trial and that utilizes patient or other resources of the main trial to generate information relevant to it.

NOTE: Ancillary studiesmust be linked to an active clinical research study and should include only patients accrued to that clinical research study.

A2. CORRELATIVE TRIAL: Laboratory based study using specimens to assess cancer risk, clinical outcomes, response to therapies, etc.

NOTE: Correlative studies must be linked to individual patient or participant data

A3. OBSERVATIONAL TRIAL: Study that focuses on cancer patients and healthy populations that involve no intervention or alteration of the status of the participants. Biomedical and/or health outcome(s) are assessed in pre-defined groups of participants.

NOTE: Participants in Observational studies may receive diagnostic, therapeutic or other interventions but the investigator is not responsible for assigning specific interventions to the participants of the study.

TYPE: For Ancillary, Correlative or Observational trials.

Please select B1, B2, B3, B4, B5, OR B6 below as the TYPE for the trial.

B1.Basic Science Trial: Protocol designed to examine the basic mechanism of action (e.g. physiology, structure functioning, composition, configuration, or biomechanics) of an intervention.

B2.Diagnostic Trial: Protocol designed to evaluate interventions aimed at identifying a disease or health condition

B3.Health Services Research Trial: Protocol designed to evaluate the delivery, processes, management, organization or financing of health care.

B4.Screening Trial: Protocol designed to assess methods of identifying a condition or risk factor in subjects who are not yet known to have the condition or risk factor.

B5.Supportive Care Trial: Protocol designed to evaluate interventions that are intended to maximize comfort, minimize side effects, or mitigate against decline in health or function.

NOTE: Supportive Care studies are not intended to cure a disease.

B6.Other Non-Intervention Trial: Clinical Non-Intervention trial that does not meet the definition of a Basic Science, Diagnostic, Health Service Research, Screening or Supportive Care study as described above.

SECTION VI: Please indicate 1) whether this protocol is a transplant protocol; 2) if it involves randomized treatment or an investigational drug; and 3) if it is intended for newly diagnosed or relapsed subjects, or both.

Transplant Protocol: Yes No

Randomized Treatment: Yes No

Investigational Drug: Yes No

Intended Subjects:Newly Diagnosed Relapsed Both Newly Diagnosed and Relapsed

SECTION VII: Please identify the tumor type/s and/or anatomic site/sthe protocol addresses.

Fred & Pamela Buffett Cancer Center Protocol Review and Monitoring System (PRMS) Office Eppley Institute (ECI) Room 3009

986805 Nebraska Medical Center Phone: (402) 559-4969

Omaha NE 68198-6805 Fax: (402) 559-4970

New Protocol Submission Form (Version 06/01/2014)Page 1 of 8

Ancillary

Brain and Neuro

Breast

Cervical

Colorectal

Endocrine

Endometrial

Esophageal

GI – Other

Genitourinary

GVHD

GYN - Other

Head/Neck

Hepatocellular

Leukemia

Lung

Lymphoma

Melanoma/Skin

Multiple Myeloma

MDS

Ovarian

Pancreatic

Prostate

Sarcoma

Other

Please Specify:

Fred & Pamela Buffett Cancer Center Protocol Review and Monitoring System (PRMS) Office Eppley Institute (ECI) Room 3009

986805 Nebraska Medical Center Phone: (402) 559-4969

Omaha NE 68198-6805 Fax: (402) 559-4970

New Protocol Submission Form (Version 06/01/2014)Page 1 of 8

SECTION VIII: Does this protocol compete with other ongoing studies at UNMC/NMCand their 1Associated Locations? Yes No

If YES, please list any competing studies (i.e. those with similar eligibility criteria) and rank them in the order of priority that they would be offered to the patient (e.g.#1, #2). Please remember to include this protocol submission in the list of studies

NOTE: Per NCI Guidelines, protocols must be ranked in the following order of priority: 1)Institutional trials; 2)National Cooperative Group trials; 3) Industry trials; and 4)Other Externally Peer Reviewed––Non-Institutional trials. A list of active studiesis available from the Fred & Pamela Buffett Cancer Center PRMS office or on their searchable web site at

ALSO NOTE: It is only necessary to list studiesthat treat the same disease population and have similar eligibility criteria when determining priority below.

Rank / IRB # / Protocol Classification / Title

SECTION IX: ACCRUAL INFORMATION and REPORTING:

During the NEXT 12 MONTHS:
What is the targeted accrual at UNMC/NMC and their1associated locations?
Forany trial with UNMC as the Study Source (i.e. Sponsor): What is the targeted accrual atall other2participating sites (if applicable)? NOTE: If more than one other site is participating, please break the targeted accrual down by site.
Forany trial with UNMC as the Study Source (i.e. Sponsor): What is the targeted accrual for the entire study, including UNMC/NMC and their 1associated locations, and all other 2participating sites?
During the DURATION OF THE STUDY:
What is the targeted accrual at UNMC/NMC andtheir1associated locations?
Forany trial with UNMC as the Study Source (i.e. Sponsor): What is the targeted accrual at all other 2participating sites (if applicable)? NOTE: If more than one other site is participating, please break the targeted accrual down by site.
Forany trial with UNMC as the Study Source (i.e. Sponsor): What is the targeted accrual for the entire study, including UNMC/NMC and 1their associated locations, plus all 2participating sites?
What is the targeted number of years this study will remain active?

1NOTE: A UNMC/NMC associated locations include but are not limited to the Bellevue Medical Center, Village Pointe Medical Center, NE Orthopedic Hospital, and UNMC/NMC Clinics.This does not include Children’s Hospital and Medical Center.

Definition of a Study That Is Partially Cancer Related: A study that includes subjects with cancer but also includes subjects who do not have cancer as their current disease diagnosis.
What is the estimated number of subjects with cancer as their current diagnosis that are expected to be included in the total targeted accrual for the entire study (answer to IX.B.3 above)?
What is the percentage of the trial that is projected to be cancer related?

NOTE: The percentage of the trial that is projected to be cancer related is determined by dividing the estimated number of subjects with cancer as their current diagnosis (answer to IX.C.1 above) by the total targeted accrual for the entire study (answer to IX.B.3 above).

SECTION X: If this is an Investigator-Initiated Institutional Treatment (i.e. Therapeutic) Intervention trial that is being conducted at participating Sites, does the PI require that pathology reports performed by the participating site(s) be reviewed by a UNMC pathologist before study related treatment begins? Yes No

SECTION XI: ACCRUAL REPORTING REQUIREMENTS:

I agree to submit copies of the consent forms for each subject registered to this study to the Fred & Pamela Buffett Cancer Center PRMS Office (Campus Zip 6805) within one week of enrollment.
NOTE: Only copies of the consent forms for subjects with cancer as their current disease diagnosis should be submitted to the PRMS office for accrual reporting for studies that are partially cancer related.

SECTION XII: New Protocol Submission Checklist (please mark all that apply and submit in order listed)

Original Signed and Dated SRC New Protocol Submission Form-required

For any trial with UNMC as the Study Source (i.e. Sponsor) that has multiple participating sites: Documentation of participating site's agreement to abide by UNMC Audit Committee and DSMC reporting requirements. - required for all sites currently participating

Cover letter and/or copy of relevant correspondence (if applicable)

Copy of the IRB Application for Biomedical Research form - required

Data collection form(s) (if applicable) - required for all Investigator-Initiated Institutional and Multi-Institutional trials

Investigator Brochure (if applicable)

Grant application (if applicable)

Protocol with version and date clearly marked on the face page

NOTE: A protocol in SRC format is required for all Investigator-Initiated Institutional Treatment Intervention, Prevention Intervention, Other Intervention, and Ancillary trials sponsored by UNMC. Instructions on preparing a protocol in SRC format are available from the Fred & Pamela Buffett Cancer Center PRMS office or on their web site at

______

Signature of Principal Investigator Date

Fred & Pamela Buffett Cancer Center Protocol Review and Monitoring System (PRMS) Office Eppley Institute (ECI) Room 3009

986805 Nebraska Medical Center Phone: (402) 559-4969

Omaha NE 68198-6805 Fax: (402) 559-4970

New Protocol Submission Form (Version 06/01/2014)Page 1 of 8