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):
PI Dept.:
Phone:
Email:
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?
Yes
No
NOTE: Tabled protocols must be resubmitted in their entirety.
SECTION II:
Check here if you believe this protocol qualifies for SRC ACCELERATED REVIEW
NOTE: Many specimen studies, retrospective medical 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 SOURCE CLASSIFICATION (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 InvestigatorInitiated Institutional trial OR a Multi-Institutional trial.
A1. INVESTIGATOR-INITIATED INSTITUTIONAL TRIAL: Protocol that has been designed and developed by a
local investigator with UNMC as the sponsor. Protocol may be implemented only at UNMC and its 1associated
locations or at multiple 2participating clinical 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.
UFred & Pamela Buffett Cancer Center Protocol Review and Monitoring System (PRMS) Office
986805 Nebraska Medical Center
Omaha NE 68198-6805
New Protocol Submission Form (Version 06/01/2014)
Eppley Institute (ECI) Room 3009
Phone: (402) 559-4969
Fax: (402) 559-4970
Page 1 of 7
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-Initiated Institutional Trial––Single-Site: Protocol sponsored by UNMC and being
implemented by local PI only at UNMC/NMC and their 1associated locations.
Investigator-Initiated Institutional 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-Initiated Institutional Trial––Industry-Supported: Protocol that is receiving some funding from
industry but that is authored by a local PI.
Investigator-Initiated Institutional Trial––Grant-Funded: Protocol that has been externally peer reviewed
for funding purposes only.
Grant Funding Source:
Grant Number:
Anticipated Grant Submission Date:
NOTE: If the protocol is part of a grant submission and is not sufficiently detailed to allow evaluation
of the science, the SRC may request a copy of the entire grant. Please attach a copy of the entire
grant if you believe this will aid the SRC in its review.
A2. MULTI-INSTITUTIONAL TRIAL: Protocol in which a local PI is participating in a study that 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
Fred & Pamela Buffett Cancer Center Protocol Review and Monitoring System (PRMS) Office
986805 Nebraska Medical Center
Omaha NE 68198-6805
New Protocol Submission Form (Version 06/01/2014)
Eppley Institute (ECI) Room 3009
Phone: (402) 559-4969
Fax: (402) 559-4970
Page 2 of 7
ACRIN
ACOSOG
COG
ECOG
EORTC
GOG
NCI CA
NSABP
NCCTG
RTOG
SWOG
American College of Radiology Imaging
American College of Surgeons Oncology Group
Children’s Oncology Group
Eastern Cooperative Oncology Group
European Organization for Research and Treatment of Cancer
Gynecologic Oncology Group
National Cancer Institute of Canada, Clinical Trials Group
National Surgical Adjuvant Breast and Bowel Project
North Central Cancer Treatment Group
Radiation Therapy Oncology Group
Southwest 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.
1. Study Source (i.e. Sponsor):
2. 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-INSTITUTIONAL TRIAL: 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 http://cancercenters.cancer.gov/documents/NCIApprovedFundingOrganizations508C.pdf)
ACS
AICR
BMT/CTN
CIRB
DOD
FDA
KOMEN
LLS
MMRF
VA
Other
American Cancer Society
American Institute for Cancer Research
Blood and Marrow Transplant Clinical Trials Network
NCI Central Institutional Review Board
Department of Defense
Food and Drug Administration
Susan G. Komen for the Cure
Leukemia and Lymphoma Society
Multiple Myeloma Research Foundation
Central Office of the Veterans Administration (excluding local/regional awards)
Please Specify
1. 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
2. Did you as investigator play a major role in the development of this protocol?
No
If YES, please explain your level of participation.
NOTE: Other Externally Peer-Reviewed trials that have not been previous reviewed by an
organization listed above will be classified as an OEPR Institutional study.
Fred & Pamela Buffett Cancer Center Protocol Review and Monitoring System (PRMS) Office
986805 Nebraska Medical Center
Omaha NE 68198-6805
New Protocol Submission Form (Version 06/01/2014)
Eppley Institute (ECI) Room 3009
Phone: (402) 559-4969
Fax: (402) 559-4970
Page 3 of 7
Yes
SECTION IV: NCI PRIMARY 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.
A. 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 health condition using behavioral modification, nutrition, dietary or
other interventions.
A3. OTHER INTERVENTION TRIAL: Clinical intervention trial that does not meet the definition of treatment intervention
or prevention intervention studies as described above.
B. 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, Expanded Access, or Single Patient Access Study
SECTION V: NCI PRIMARY PURPOSE and TYPE (for Non-Intervention trials only).
DEFINITION OF NON-INTERVENTION TRIAL: An Ancillary, Correlative or Observational trial using clinical specimens
that can be linked to individual patient or participant data.
A. PRIMARY PURPOSE for Non-Intervention Trials: Please select either A1, A2 OR A3 below as the Primary
Purpose for the trial.
Fred & Pamela Buffett Cancer Center Protocol Review and Monitoring System (PRMS) Office
986805 Nebraska Medical Center
Omaha NE 68198-6805
New Protocol Submission Form (Version 06/01/2014)
Eppley Institute (ECI) Room 3009
Phone: (402) 559-4969
Fax: (402) 559-4970
Page 4 of 7
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 studies must 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.
B. 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/s the protocol addresses.
Ancillary
Brain and Neuro
Breast
Cervical
Colorectal
Endocrine
Fred & Pamela Buffett Cancer Center Protocol Review and Monitoring System (PRMS) Office
986805 Nebraska Medical Center
Omaha NE 68198-6805
New Protocol Submission Form (Version 06/01/2014)
Endometrial
Esophageal
GI – Other
Eppley Institute (ECI) Room 3009
Phone: (402) 559-4969
Fax: (402) 559-4970
Page 5 of 7
Genitourinary
GVHD
GYN - Other
Head/Neck
Hepatocellular
Leukemia
Lung
Lymphoma
Melanoma/Skin
Multiple Myeloma
MDS
Ovarian
Pancreatic
Prostate
Sarcoma
Other
Please Specify:
SECTION VIII: Does this protocol compete with other ongoing studies at UNMC/NMC and 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
studies is available from the Fred & Pamela Buffett Cancer Center PRMS office or on their searchable web site at
http://crweb.unmc.edu/CTO/CTO_Main_Page.jsp.
ALSO NOTE: It is only necessary to list studies that 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:
A. During the NEXT 12 MONTHS:
1. What is the targeted accrual at UNMC/NMC and their 1associated locations?
2. For any 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.
3. For any 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?
B. During the DURATION OF THE STUDY:
1. What is the targeted accrual at UNMC/NMC and their 1associated locations?
2. For any 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.
3. For any 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?
4. What is the targeted number of years this study will remain active?
Fred & Pamela Buffett Cancer Center Protocol Review and Monitoring System (PRMS) Office
986805 Nebraska Medical Center
Omaha NE 68198-6805
New Protocol Submission Form (Version 06/01/2014)
Eppley Institute (ECI) Room 3009
Phone: (402) 559-4969
Fax: (402) 559-4970
Page 6 of 7
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.
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.
C. 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.
1. 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)?
2. 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
http://www.unmc.edu/cancercenter/prms.htm.
___________________________________
Signature of Principal Investigator
Fred & Pamela Buffett Cancer Center Protocol Review and Monitoring System (PRMS) Office
986805 Nebraska Medical Center
Omaha NE 68198-6805
New Protocol Submission Form (Version 06/01/2014)
________________
Date
Eppley Institute (ECI) Room 3009
Phone: (402) 559-4969
Fax: (402) 559-4970
Page 7 of 7