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NEW PROTOCOL SUBMISSION FORM
For Trials to be Opened ONLY at Children's Hospital and Medical Center (Children's)
Instructions: Please complete and submit this form to the UNMC Eppley 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: In 2012, the submission deadline is Friday,
September 21st; Wednesday, November 21st due to Thanksgiving; and Friday, December, 19th due to
Christmas.
SECTION I: BASIC PROTOCOL DATA
Current IRB#: Previous Children's IRB #:
Title:
PI: Phone: Email:
Study Coordinator/Contact: Phone: Email:
Data Coordinator/Contact: 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, 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: SRC CLASSIFICATION – Please identify the Classification that best matches this protocol.
A. INVESTIGATOR-INITIATED INSTITUTIONAL TRIAL: Protocol that has been designed and developed by a
local investigator. Protocol may be implemented only at UNMC/The Nebraska Medical Center (UNMC/NMC) or
at multiple 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.
Single-Site Trial: Protocol being implemented by local PI at UNMC/NMC only.
Multi-Site Trial: Protocol being implemented by local PI at more than one *Affiliate site.
*Affiliate Site(s) where trial will be implemented:
*NOTE: An Affiliate Site is defined as a hospital, clinic, or other provider of medical services who has been
granted a limited license to use the designation “an AFFILIATE of the Eppley Cancer Center” for purposes
related to oncology research conducted pursuant to an “Affiliate Agreement”.
Industry-Supported Trial: Protocol that is receiving some funding from industry.
UNMC Eppley Cancer Center Protocol Review and Monitoring System (PRMS) Office Eppley Science Hall (ESH) Room 10006, 10007 AND 10018
986805 Nebraska Medical Center Phone: (402) 559-4969
Omaha NE 68198-6805 Fax: (402) 559-4970
New Project Submission Form - Open at Children's ONLY (Version 09/10/2012) Page 1 of 5
Grant-Funded Trial: 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.
B. MULTI-CENTER INSTITUTIONAL TRIAL: Protocol being implemented at multiple Participating clinical sites
and where more than one IRB approval is required.
C. 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 (ACSOG, CALGB and NCCTG)
ACRIN CALGB ECOG GOG NSABP RTOG
ACSOG COG EORTC NCICA NCCTG SWOG
Did you as investigator play a major role in the development of this protocol? No Yes
If yes, please explain your level of participation.
D. INDUSTRIAL TRIAL: Protocol that is designed, developed and monitored by Industry.
Did you as investigator play a major role in the development of this protocol? No Yes
If YES, please explain your level of participation.
E. OTHER EXTERNALLY PEER-REVIEWED 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.
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: NCI CLASSIFICATION and PHASE (for intervention trials) or TYPE (for non-intervention trials)
A. THERAPEUTIC INTERVENTION TRIAL: Clinical trial with therapeutic intent using an agent or device (e.g.
drugs, radiation, surgery, and/or biological agents).
B. PREVENTION INTERVENTION TRIAL: Clinical trial for the modulation of cancer risk and inhibition of cancer
progression using behavioral modification, nutrition, dietary or chemoprevention interventions.
1. PHASE: For either (A) Therapeutic or (B) Prevention Intervention Trials, please indicate the study PHASE.
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.
UNMC Eppley Cancer Center Protocol Review and Monitoring System (PRMS) Office Eppley Science Hall (ESH) Room 10006, 10007 AND 10018
986805 Nebraska Medical Center Phone: (402) 559-4969
Omaha NE 68198-6805 Fax: (402) 559-4970
New Project Submission Form - Open at Children's ONLY (Version 09/10/2012) Page 2 of 5
Phase I: Protocols designed to determine a safe method/dose for Phase II trials and define acute
effects that occur with a relatively high frequency in normal tissues.
Phase II: Protocols designed to a) determine whether a treatment/agent has anti-tumor activity and
b) estimate the response rate in a defined patient population.
Phase III: Protocols designed to compare the new drug or treatment modality with standard
treatment or observation, if no standard treatment exists.
Phase IV: Protocols designed to evaluate side effects that were not apparent in Phase III trials after
a treatment has been approved and is being marketed.
Combination: Phase I/II Other: Please specify
C. OTHER INTERVENTION TRIAL: Clinical trial designed to study treatment for symptoms and side effects of
cancer-related therapies and trials that do not meet the definition of therapeutic or prevention intervention
studies as described above.
D. NON-INTERVENTION TRIAL: 1) Epidemiologic, outcome, or other observational study; or 2) study
associated with a clinical trial or other biological study using clinical specimens that can be linked to individual
patient or participant data.
1. TYPE: For Non-Intervention Trials, please indicate the study TYPE.
Screening, Early Detection, or Diagnostic Trial: Protocol designed to test the efficacy of devices,
techniques, procedures, or tests for earlier/more accurate detection or diagnosis of disease.
Supportive Care Trial: Protocol designed to improve the comfort and quality of life for the patient.
Epidemiologic/Observational Trial: Study among cancer patients and healthy populations that
involve no intervention or alteration in the status of the participants (e.g., surveillance, risk
assessment, environmental and behavioral studies, etc.)
Ancillary or Companion Trial: Auxiliary 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: Companion or ancillary studies must be linked to an active trial, or epidemiologic or other
observational study (screening, early detection, diagnostic; therapeutic; or prevention) and should
include only patients accrued to that trial or study.
Correlative Trial: Laboratory based study using specimens to assess cancer risk, clinical outcomes,
response to therapies, etc.
NOTE: Correlative studies must be linkable to other patient data.
SECTION V: 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
UNMC Eppley Cancer Center Protocol Review and Monitoring System (PRMS) Office Eppley Science Hall (ESH) Room 10006, 10007 AND 10018
986805 Nebraska Medical Center Phone: (402) 559-4969
Omaha NE 68198-6805 Fax: (402) 559-4970
New Project Submission Form - Open at Children's ONLY (Version 09/10/2012) Page 3 of 5
SECTION VI: Please identify the tumor type/s and/or anatomic site/s the protocol addresses.
Ancillary Genitourinary Multiple Myeloma
Brain and Neuro GVHD MDS
Breast GYN - Other Ovarian
Cervical Head/Neck Pancreatic
Colorectal Hepatocellular Prostate
Endocrine Leukemia Sarcoma
Endometrial Lung Other
Esophageal Lymphoma Please Specify:
GI - Other Melanoma/Skin
SECTION VII: Does this protocol compete with other ongoing studies currently open to accrual at Children's?
Yes No
If YES, please list any competing protocols (i.e. those with similar eligibility criteria) and rank them in the order of
priority that they would be offered to the patient (i.e. #1, #2).
NOTE: Per NCI Guidelines, protocols must be ranked in the following order of priority: 1) Investigator-Initiated
Institutional trials; 2) Multi-Center Institutional trials; 3) National Cooperative Group trials; 4) Industry trials; and 5)
Other Externally Peer Reviewed trials. A list of active Children's protocols is available from the Eppley Cancer Center
PRMS office or on their web site at http://www.unmc.edu/ccto/.
ALSO NOTE: It is only necessary to list protocols that treat the same disease population and have similar
eligibility criteria when determining priority below.
Rank IRB # Protocol Classification Title
(Investigator-Initiated, Multi-
Center, National Cooperative
Group, Industrial or Other
Externally Peer Reviewed)
SECTION VIII: CHILDREN'S and OVERALL ACCRUAL PROJECTION, INFORMATION and REPORTING:
A. During the NEXT 12 MONTHS:
1. What is the targeted accrual at Children's? (if applicable)
2. What is the targeted accrual for the entire study, including all participating sites?
B. During the DURATION OF THE STUDY:
1. What is the targeted accrual at Children's?
UNMC Eppley Cancer Center Protocol Review and Monitoring System (PRMS) Office Eppley Science Hall (ESH) Room 10006, 10007 AND 10018
986805 Nebraska Medical Center Phone: (402) 559-4969
Omaha NE 68198-6805 Fax: (402) 559-4970
New Project Submission Form - Open at Children's ONLY (Version 09/10/2012) Page 4 of 5
2. What is the targeted accrual for the entire study, including all participating sites?
3. What is the targeted number of years this study will remain active?
C. ACCRUAL REPORTING REQUIREMENTS:
I agree to submit copies of the consent forms for each subject registered to this protocol to the UNMC Eppley
Cancer Center PRMS Office (Campus Zip 6805) within one week of enrollment.
SECTION IX: New Protocol Submission Checklist (please mark all that apply and submit in order listed)
Original Signed and Dated SRC New Protocol Submission Form - required
Cover letter and/or copy of relevant correspondence (if applicable)
Copy of the IRB Application for Biomedical Research form, Sections I and II - required
Consent form/s (if applicable)
Data collection form/s (if applicable) - required for all Investigator-Initiated and Multi-center 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 and Therapeutic Intervention Pilot trials.
Instructions on preparing a protocol in SRC format are available from the UNMC Eppley Cancer Center Clinical Trials
office or on their web site at http://www.unmc.edu/ccto/.
___________________________________ ________________
Signature of Principal Investigator Date
UNMC Eppley Cancer Center Protocol Review and Monitoring System (PRMS) Office Eppley Science Hall (ESH) Room 10006, 10007 AND 10018
986805 Nebraska Medical Center Phone: (402) 559-4969
Omaha NE 68198-6805 Fax: (402) 559-4970
New Project Submission Form - Open at Children's ONLY (Version 09/10/2012) Page 5 of 5
