Cancer Consortium Submission Form

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Cancer Consortium Submission Form
Submit completed forms to Clinical Research Support via [email protected] If you have questions about
the form, or would like information about Clinical Research Support, please call 206-667-4520 or visit the website.
Note: The completed form is subject to review by CRS. Certain data elements may need to be changed to conform to
NCI definitions.
Information from this form will be used to determine:

Data reporting
 NCI Cancer Center Support Grant
 NCI Clinical Trials Reporting Program
 ClinicalTrials.gov

Committee review
Note: SRC review is required for all Interventional studies, both therapeutic (a drug, agent or device) and
non-therapeutic (diet, exercise, behavior), prior to IRB submission. (Studies sponsored by an NCIrecognized national cooperative group undergo expedited SRC review.)

Study monitoring
Date:
Protocol Number:
Principal
Investigator:
Mailstop:
Phone:
Contact Person:
Mailstop:
Phone:
Protocol Title
00312 Cancer Consortium Submission Form
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Version: 05/11/2015
Cancer Consortium Submission Form
Section A
General Information (this section is required for all studies)
1.
Protocol will be submitted to IRB at:
Cancer Consortium/Fred Hutch
2.
Western IRB
Seattle Children’s
NCI CIRB
Other:
Institution receiving grant/award/contract (check only one):
__________________________________________________________________________________________
Fred Hutchinson Cancer Research Center:
Identify Fred Hutch division or group submitting study:
CRD
PHS
Basic Sciences
VIDD
Human Biology
__________________________________________________________________________________________
University of Washington
REMINDER: Please be sure to include the Cancer Consortium Protocol Fees in your study budget. For details,
please see our website: http://www.cancerconsortium.org/en/support/study-management/study-startup/protocol-fees.html
__________________________________________________________________________________________
Seattle Children’s
3.
Is this a multi-center study?
Yes
No
If yes, what is the name of the coordinating center and/or operations center (institution, company, cooperative group)?:
________
4.
Does this study include study-related services, items or tests provided by a practitioner or entity that bills through UW
Physicians, UW Medicine Patient Financial Services, CRBB and/or SCCA?
Yes
No
See https://depts.washington.edu/crbb/docs/UWMedicinePolicy01.pdf and
https://depts.washington.edu/crbb/docs/UWMedicinePolicy01Appendix01BillingEntityBySite.pdf for additional
information.
If yes, you must submit your study to both the SCCA Research Implementation Office [email protected] and the UW
Clinical Research Budgeting and Billing Office [email protected] for review.
00312 Cancer Consortium Submission Form
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Cancer Consortium Submission Form
5.
Study Source (Primary sponsor/funding source)
For definitions, see:
http://cancerconsortium.org/en/support/forms/ReferenceDocuments/cancer-consortium-submission-form--data-guidance.html
Check only one
For CRS purposes only
Investigator-initiated with peer-reviewed funding (e.g., NCI, NHLBI, ACS)
EXT
Agency:
Investigator-initiated with other funding (or without any study-specific funding)
INS
Name(s) of company, foundation, pilot funds, other:
Industry sponsored and funded
Company:
INDustrial
Sponsor Study # (optional):
NCI National Clinical Trials Network (NCTN) and other NIH-supported National Trial Networks
NAT
Group:
6.
Primary Purpose (check only one):
Treatment
Protocol designed to evaluate one or more interventions for treating a disease, syndrome or
condition.
Supportive Care
Protocol designed to evaluate one or more interventions where the primary intent is to
maximize comfort, minimize side effects or mitigate against a decline in the subject's health or
function. In general, supportive care interventions are not intended to cure a disease.
Prevention
Protocol designed to assess one or more interventions for preventing, or decreasing the chance
of getting, a specific disease or condition. For example, cancer prevention may include avoiding
risk factors and increasing protective factors.
Screening
Protocol designed to assess or examine methods of identifying a condition (or risk factors for a
condition) in people who are not yet known to have the condition (or risk factor).
Basic Science
Protocol designed to examine the basic mechanism of action (e.g., physiology, biomechanics) of
an intervention.
Diagnostic
Protocol designed to evaluate one or more interventions aimed at identifying a disease or health
condition.
Health Services
Research
Protocol designed to evaluate the delivery, processes, management, organization or financing of
health care.
Other (specify):
00312 Cancer Consortium Submission Form
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Cancer Consortium Submission Form
7.
Phase of study (check only one):
For definitions, see:
http://cancerconsortium.org/en/support/forms/ReferenceDocuments/cancer-consortium-submission-form--data-guidance.html
Pilot/Feasibility
I
I/II
II
II/III
III
IV
Not applicable (State reason: e.g., behavioral, epidemiologic, etc.):
8.
Primary diseases / disease sites being investigated in this study (not site of symptoms or complications)
Check all that apply. If this is a cancer-related, treatment study, select at least one of the hematological or solid tumor terms
listed below.
Hematological
Non-Hodgkin Lymphoma
Multiple Myeloma
Myeloid and Monocytic Leukemia
Hodgkin Lymphoma
Lymphoid Leukemia
Leukemia, other
Other Hematopoietic
Solid Tumor
Lip, oral cavity,
pharynx
Pancreas
Kaposi's sarcoma
Prostate
Other Digestive Organ
Mycosis Fungoides
Other Male Genital
Esophagus
Larynx
Other Skin
Bladder
Stomach
Lung
Breast – Female
Kidney
Small intestine
Other Respiratory and
Intrathoracic Organs
Breast – Male
Other Urinary
Colon
Cervix
Eye and Orbit
Rectum
Bones and Joints
Uterus (Corpus Uteri)
Brain and Nervous system
Anus
Soft Tissue
Ovary
Thyroid
Liver
Melanoma, skin
Other Female Genital
Other Endocrine System
Other
Aplastic Anemia
GVHD
Rheumatoid Arthritis
Barrett's Esophagus
HIV/AIDS
Scleroderma
Crohn's Disease
Immune Disorders
Sickle Cell Disease
Cystic Fibrosis
Influenza
Other (non-cancer) disease:
Disease not listed. Specify disease (non-treatment studies only):
9.
Research program or affinity group with which the study is aligned (check only one):
For program descriptions, see http://cancerconsortium.org/en/science.html
Women’s Cancer
Biostatistics and Computational Biology
Hematologic Malignancies
Prostate Cancer
Cancer Basic Biology
Cancer Epidemiology, Prevention and Control
Gastrointestinal Cancer
Immunology & Vaccine Development
Not programmatically aligned
Global Oncology
00312 Cancer Consortium Submission Form
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Cancer Consortium Submission Form
10. Does the protocol only enroll healthy volunteers?
Yes
No
11. Core grant exclusions (Check any that apply):
A.
This is an in vitro study that utilizes human tissues that cannot be linked to a living individual
B.
Studies assembling repositories of data, tissue, or samples for unspecified future use.
C.
Participants do not provide written consent for this specific study (e.g. retrospective)
D.
Single patient treatment use protocol
E.
Humanitarian Use Device
F.
Expanded Access protocol
If you chose A, B or C, stop here and submit the form to CRS. (Answer questions 1 – 11.)
If you chose D, E or F, complete all of section A and B, questions 1 – 19. (You do not need to complete sections C or D,
questions 20 – 24.)
12. Is this study related to non-malignant disease (e.g., cardiovascular studies, neurologic disorders, HIV vaccine trials)?
Yes
No
If yes, specify:
If yes,
A. Is this a study of symptoms or complications of treatment where cancer is the primary disease?
B.
Is transplantation an intervention in this study?
Yes
Yes
No
No
13. Clinical Research Category best describing the study (check only one):
Interventional: Individuals are assigned by the investigator based on this protocol to receive specific interventions. 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.
Do any of the study interventions involve a drug, agent or device?
Yes
No
Ancillary: Prospective, non-interventional studies that are stimulated by, but not a required part of, a main clinical
trial/study, and that utilize patient or other resources of the main trial/study to generate information relevant to it. Ancillary
studies must be linked to an active clinical research study and should include only patients accrued to that clinical research
study.
Correlative: Prospective, non-interventional, laboratory-based studies using specimens to assess cancer risk, clinical
outcomes, response to therapies, etc. Study is linked to individual participant data.
Observational: Clinical Research Category in which the studies focus on cancer patients and healthy populations that
involve no intervention or alteration in the status of the participants. Biomedical and/or health outcome(s) are assessed in predefined groups of participants. The participants in the study may receive diagnostic, therapeutic, or other interventions but
the investigator of the observational study is not responsible for assigning specific interventions to the participants of the
study.
00312 Cancer Consortium Submission Form
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Cancer Consortium Submission Form
Section B
Cancer Center Support Grant (Core grant)
Protocol Monitoring and Review
14. Person responsible for entering accrual data in PATS (Primary Contact):
15. Is there a dedicated DSMB for this study?
Yes
No
If yes, indicate the schedule for DSMB review (check only one):
DSMB will meet every:
month(s)
DSMB will meet after:
subjects are enrolled
DSMB will meet after:
number of events
Other (please explain):
Will the DSMB be created within the Cancer Consortium?
Yes
No
16. Is an external sponsor or cooperative group responsible for monitoring this study?
Yes
No
If yes, identify the following:
Name of external monitoring group:
If no, this study may require monitoring through the Cancer Consortium. Indicate the monitoring level below:
High: Trials supporting investigator-sponsored INDs; Phase 1 trials; gene therapy trials, NIH high risk trials
Medium: All other trials involving therapeutic intervention (i.e., drugs, biologics or devices)
Low: Trials involving non-therapeutic intervention (i.e., nutritional or behavioral trials)
17. Sample size and anticipated duration
Specify enrollment and duration in numbers. Do not provide a range and do not enter “unknown” or “unlimited.”
Targeted enrollment
(number of participants)
Anticipated duration of accrual (number
of months)
Cancer Consortium (UW, FH, SC)
Multi-center study: Total
(Consortium + external sites)
18. For multi-center studies that are already open to accrual (Consortium site is not the coordinating site):
How long has study been open?
What is the current overall enrollment?
19.
Is there an Investigational New Drug (IND) associated with this study?
Is there an Investigational Device Exemption (IDE) associated with this study?
If yes, indicate the following:
FDA center issuing IND/IDE [Grantor]:
CDER (Drug)
CBER (Biologic)
Yes
Yes
No
No
CDRH (Device)
IND/IDE #:
IND/IDE Holder:
Expanded Access Protocol?
Yes
No
If this is a multi-center trial and a Cancer Consortium investigator is the IND/IDE holder, you will be contacted by CRS staff regarding
additional site review requirements.
00312 Cancer Consortium Submission Form
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Cancer Consortium Submission Form
Section C
Study Team Members
Study team members performing these roles must have GCP training per the Cancer Consortium GCP training policy.
This section is required for therapeutic, interventional trials only.
20. List the names of all of the following:
Consortium Sub-investigators
Consortium Biostatistician(s)
Consortium Research Nurse(s)
Consortium Clinical Research Coordinator(s)
Consortium Regulatory Coordinator(s)
Consortium Research Manager
Section D
NCI’s Clinical Trials Reporting Program (CTRP) and NIH’s ClinicalTrials.gov
This section is required for investigator-initiated, interventional trials only.
21. Is study reviewed and monitored by NCI's Cancer Therapy Evaluation Program (CTEP)?
Yes
No
If yes, CTEP ID Number:
22. Anticipated Start Date (estimated month/year when you anticipate the study will open to enrollment):
(If this study is being transferred from UW-HSD, provide actual start date.)
23. Anticipated Primary Completion Date (estimated month/year when you anticipate all data will be collected to answer all primary
objectives):
For more information, see:
http://cancerconsortium.org/en/support/forms/ReferenceDocuments/cancer-consortium-submission-form--data-guidance.html
24. Is this study already registered on ClinicalTrials.gov?
Yes
No
If yes, provide the ClinicalTrials.gov ID number (11-digit NCT ID):
00312 Cancer Consortium Submission Form
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Version: 05/11/2015
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