Completed by CSRC office
Principal Investigator
The PI must complete this form and provide signature.
Name: Email:
Principal Investigator:
* must provide value
Principal Investigator Email:
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Clinical research category:
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Interventional: Studies where participants are assigned by a protocol to receive specific interventions (e.g., diagnostic, prevention or therapeutic) and outcomes are measured
Non-interventional: Studies where outcomes are measured in predefined groups, but the investigator does not
Non-interventional clinical research category:
* must provide value
Observational: Studies among cancer patients and healthy individuals with no interventions or alterations assigned by the protocol or investigator. Biomedical and/or health outcomes are assessed in pre-defined groups. Participants may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign these in an observational study.
Ancillary: Secondary to another trial. Studies that are stimulated by, but are not a required part of, a main clinical study, and that utilize patient or other resources of the main 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 : Laboratory-based studies using specimens to assess cancer risk, clinical outcomes, response to therapies, etc. Report only those studies that can be linked to individual patient or participant data.
Retrospective : Chart review.
Basic Science: Protocol designed to examine the basic mechanisms of action (e.g., physiology, biomechanics) of an intervention
Device Feasibility: An intervention of a device product is being evaluated in a small clinical trial (generally fewer than 10 participants) to determine the feasibility of the product; or a clinical trial to test a prototype device for feasibility and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before beginning a full clinical trial.
Diagnostic: Protocol designed to evaluate one of 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
Prevention: Protocol designed to assess one or more interventions aimed at preventing the development of a specific disease or health condition
Screening: Protocol designed to assess or examine methods of identifying a condition (or risk factor for a condition) in people who are not yet known to have the condition (or risk factor)
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 participant's health or function. In general, supportive care interventions are not intended to cure a disease
Treatment/Therapeutic: Protocol designed to evaluate one or more interventions for treating the patient's cancer (also referred to as therapeutic clinical trial)
Other
Basic Science: Protocol designed to examine the basic mechanisms of action (e.g., physiology, biomechanics) of an intervention not assigned by the protocol or investigator
Device Feasibility: An intervention (not assigned by the protocol or investigator) of a device product is being evaluated in a small clinical trial (generally fewer than 10 participants) to determine the feasibility of the product; or a clinical trial to test a prototype device for feasibility and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before beginning a full clinical trial.
Diagnostic: Protocol designed to evaluate one of more interventions (not assigned by the protocol or investigator) 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
Prevention: Protocol designed to assess one or more interventions (not assigned by the protocol or investigator) aimed at preventing the development of a specific disease or health condition
Screening: Protocol designed to assess or examine methods of identifying a condition (or risk factor for a condition) in people who are not yet known to have the condition (or risk factor)
Supportive Care: Protocol designed to evaluate one or more interventions (not assigned by the protocol or investigator) where the primary intent is to maximize comfort, minimize side effects, or mitigate against a decline in the participant's health or function. In general, supportive care interventions are not intended to cure a disease
Other
Early Phase I: Exploratory trials involving very limited human exposure with no therapeutic or diagnostic intent (e.g., screening studies, microdose studies)
Phase I: Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients
Phase I/II: Trials that are a combination of phases 1 and 2
Phase II: Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks
Phase II/III: Trials that are a combination of phases 2 and 3
Phase III: Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug
Phase IV: Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use
N/A: Trials without phases (for example, studies of devices or behavioral interventions)
Yes
No
Is this a pragmatic trial?
A pragmatic trial is a clinical trial designed to study a health intervention in a real-world setting that is similar or identical to the one in which the intervention will be implemented.
NCI classifies trials with the following characteristics as pragmatic:
Unit of randomization may be other than an individual participant (e.g., the clinic, the healthcare system, or a neighborhood if a community setting) Intervention may be multi-level involving changes to: Participant behavior (e.g., completing a symptom report measures online), and Provider behavior (e.g., receiving the participant's symptom report and having to act on it) Data are often obtained directly from medical records and are likely collected on a large number of participants Data may be collected during a pre-intervention period and again during a post-intervention period in each clinic that is randomized Participants for whom data are collected in the pre-intervention period may not be the same ones for whom data are collected in the post-intervention period * must provide value
Yes
No
Industry sponsor:
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Sponsor:
* must provide value
Please specify study sponsor:
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Alliance for Clinical Trials in Oncology
ECOG-ACRIN Cancer Research Group
NRG Oncology
SWOG Cancer Research Network
AIDS Malignancy Consortium (AMC)
Blood and Marrow Transplant Clinical Trials Network (BMT CTN)
Gynecologic Oncology Group (GOG)
Other cooperative group
Other cooperative group sponsor:
* must provide value
Additional funding if relevant:
Did the OSU PI have a role in the scientific development of the trial?
* must provide value
Yes
No
Select all that apply:
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Biostatistician who authored/reviewed the protocol:
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Is your protocol required to be on an external sponsor's/funder's template?
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Yes
No
Please note that your protocol must be on the OSU IRB's Huron template. Is your protocol on the OSU IRB's Huron template?
* must provide value
Yes
No
Please visit the Huron IRB Library or contact your Regulatory Compliance Officer to obtain the current template .
Scope:
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Local (OSU only)
National (Multi-site trial)
Proposed subsites:
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Is this study part of the UM1 NCI Experimental Therapeutics Clinical Trial Network (ETCTN)?
* must provide value
Yes
No
Is this an OSU compassionate use trial?
* must provide value
Yes
No
A data and safety monitoring plan is required for all interventional studies. Please confirm a data and safety monitoring plan is included.
* must provide value
Yes
No
Please explain:
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Does this protocol require an IND (investigational new drug) or IDE (investigational device exemption) application to the FDA?
* must provide value
Yes
No
Which one?
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IND
IDE
Has FDA approval been obtained?
FDA approval is required prior to CSRC review.
* must provide value
Yes
No
CSRC review will not move forward unless FDA approval has been obtained. Please reach out to CTO.Implementation@osumc.edu for further guidance.
Total Lower OSU Accrual Goal: Total Upper OSU Accrual Goal: Annual OSU Accrual Goal: Accrual Duration:
Lower:
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Upper:
* must provide value
Annual:
* must provide value
Accrual duration:
* must provide value
months
Estimated screen failure rate:
* must provide value
%
Total protocol target accrual for all sites:
* must provide value
Annual accrual goal falls outside of the accrual goal range
Upper accrual for OSU is greater than the total target accrual for all sites
Describe efforts to accrue minority and underserved populations.
Please specify other efforts:
Please choose the program that best aligns with the scientific goals and aims of the trial:
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Cancer Biology (CB): Studies focused on the molecular, cellular, or genetic basis of cancer
Cancer Control (CC): Studies focused on cancer risk, early detection, screening, behavior, survivorship or health equity
Leukemia and Hematologic Malignancies (LHM): Studies focused on leukemia, lymphoma, myeloma or other blood cancers
Molecular Carcinogenesis and Chemoprevention (MCC): Studies focused on the molecular mechanisms of carcinogenesis and chemoprevention through dietary and lifestyle interventions
Translational Therapeutics (TT): Studies that evaluate or develop new treatment strategies from bench to bedside
Disease Specific Research Group (DSRG):
* must provide value
Acute Leukemia BMT Breast Chronic Myeloid CLL CNS GI GU Gyn Onc Head & Neck Lymphoma Melanoma Myeloma Phase I Sarcoma Thoracic Thyroid/Neuroendocrine Other
Tumor Types
Select all that apply.
* must provide value
Yes
No
Please specify rare cancers:
* must provide value
Location(s) where research will take place
Location(s) where patient will be treated
______
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Yes
No
View equation
Specify other management:
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Is this a basket trial that will involve multiple disease teams?
Yes
No
Please select the teams that have confirmed their participation.
Is this a dose escalation/expansion study?
Yes
No
In what stage of the protocol will we be participating?
Dose escalation and expansion
Dose expansion only
Is this an umbrella trial for which Total Cancer Care assistance is requested for cohort identification due to rare mutation(s) subsets?
Yes
No
Does this trial involve administering investigative radiopharmaceuticals, radioactive drugs, and/or radioactive isotopes for treatment or imaging purposes that are potentially outside of standard of care?
Yes
No
Does the trial involve ANY use of molecular diagnostic testing as a primary endpoint (e.g., FISH, molecular result, mutation presence/absence as an enrollment criteria, or monitoring response of mutation/genetics over therapy to change dose, continue, or discontinue therapy)?
Yes
No
Does the trial involve ANY use of diagnostics as a secondary endpoint (e.g., FISH or molecular response as predictor of response or outcome)?
Yes
No
Which specific molecular/biomarker assays are proposed to be performed for the endpoints listed above?
Tumor next-generation sequencing will be performed at:
OSU
Other lab
Next-generation sequencing other lab:
Tumor IHC/FISH will be performed at:
OSU
Other lab
Tumor IHC/FISH other lab:
Select all that apply:
Note that CTO management includes case report form development (if applicable), regulatory support, clinical research and data coordination, and Clinical Trials Processing Laboratory support.
Select all that apply:
Note that RISSR management includes database development (if applicable), regulatory support, clinical research and data coordination.
Specify:
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View equation
Has your trial been submitted to Clinical Research Finance and Compliance (CRFC) for pre-budget review and been approved to move forward?
* must provide value
Yes
No
Workfront Reference Number:
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All CTO- and RISSR-managed IITs are required to undergo budget review prior to CSRC review. Please submit a budget request at go.osu.edu/ccc-budget .
Exception: Big Ten IITs do not require budget review and will move forward to CSRC.
Will any currently accruing or pending trials compete with the trial being submitted?
* must provide value
Yes
No
Title: OSU#: Accrual to date: PI: Yearly accrual goal: Date opened:
Title: OSU#: Accrual to date: PI: Yearly accrual goal: Date opened:
Title: OSU#: Accrual to date: PI: Yearly accrual goal: Date opened:
Title:
* must provide value
OSU#:
* must provide value
Date opened:
* must provide value
M-D-Y
Yearly accrual goal:
* must provide value
Accrual to date:
* must provide value
M-D-Y
M-D-Y
If there is overlap, describe how you will address (e.g., there are enough patients for both trials):
* must provide value
Fit with Catchment Area Priorities High priority cancers include lung, breast, colorectal, prostate, endometrial, cervical cancer, thyroid, and leukemia, as well as tobacco use, obesity and HPV vaccination.
Promotes Research Program Science
Ability to accrue across the life of the trial
Feasibility
Overlap with existing trials
TOTAL SCORE
Fit with Catchment Area Priorities
* must provide value
3: Priority cancer and/or addresses health disparity
2: Non-priority cancer
1: Rare cancer
Promotes Research Program Science
* must provide value
3: Directly based on OSU discovery or OSU leadership role (IITs and studies where OSU is national lead - PI, steering committee, etc.)
2: Indirect relation to OSU science or OSU lab performing correlates
1: Little or no relation to OSU science
Ability to accrue across the life of the trial
* must provide value
3: ≥ 10 predicted accruals
2: 5-10 predicted accruals
1: < 5 accrual anticipated
Feasibility
* must provide value
3: No feasibility issues
2: Somewhat complex regimen or has intensive correlates/special tests
1: Complex or intensive regimen with feasibility issues
Overlap with existing trials
* must provide value
3: No overlap
2: Some overlap that can be mitigated
1: High degree overlap/competes directly
View equation Please indicate additional factors that necessitate the opening of this study as a service to OSUCCC patients:
Click below to attach the protocol.
This must be the final version.
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PI Signature:
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PI Date Signed:
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Today M-D-Y
DSRGL/Approver:
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Backes, Floor Benson, Don Borate, Uma Brownstein, Jeremy Burns, Timothy Chakravarti, Arnab Contreras, Carlo De Lima, Marcos Giglio, Pierre Jhawar, Sachin Kendra, Kari Khan, Abdullah Konda, Bhavana Liebner, David Mayerson, Joel Miller, Eric Mims, Alice Monk, Paul Noonan, Anne O'Malley, David Paskett, Electra Rocco, James Sardesai, Sagar Sawalha, Yazeed Singer, Eric Vasu, Sumithira Vaughn, Jennifer Wesolowski, Robert Woyach, Jennifer
TO BE COMPLETED BY PI
Edits completed - send back to Approver
Today M-D-Y
Second round of edits completed - send back to Approver
Today M-D-Y
Third round of edits completed - send back to Approver
Today M-D-Y
FORM CHECKED - APPROVER CONFIRMED Form checked, approver confirmed
TO BE COMPLETED BY APPROVER
Please indicate if the intake form needs to be edited by the PI or is ready to submit.
Approve and submit form to CSRC
Send back to PI for revisions
Date sent back to PI:
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Today M-D-Y
Please indicate if the intake form needs to be edited again by the PI or is ready to submit.
Approve and submit form to CSRC
Send back to PI for revisions
Date sent back to PI:
* must provide value
Today M-D-Y
Please indicate if the intake form needs to be edited again by the PI or is ready to submit.
Approve and submit form to CSRC
Send back to PI for revisions
Date sent back to PI:
* must provide value
Today M-D-Y
Please indicate if the intake form needs to be edited again by the PI or is ready to submit.
Approve and submit form to CSRC
Notify CSRC that additional edits are still required
DSRGL/Approver signature:
DSRGL/Approver signature:
* must provide value
DSRGL/Approver date signed:
* must provide value
Today M-D-Y
Submit
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