Survey Date (auto populates, not seen on public survey)
Today M-D-Y
Who is submitting the feasibility form?
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Study Team
Research Admin Team
Enter Name of Person Submitting Form:
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Enter email address of person submitting the form:
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Principal Investigator Full Name:
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Principal Investigator Email:
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Select Name of Research Manager
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Cheryl Stone - Pediatric Research Unit (PRU)
Kaitlin Jones - Egleston (Emergency Medicine, Trauma, Critical Care Medicine, Radiology, Sustainability)
Morgan Van Dresser - Egleston (MPACT, Cardiac/CT Sugery, Anesthesia, General Surgery, ENT)
Rebecca Cleeton - Center for Advanced Pediatrics (CAP)
Marco Benoit - Scottish Rite/Hughes Spalding
Ansley Reich - Marcus Autism
Sarah Marie Huban - Emory Department of Pediatrics
Sarah Marie Huban - Emory Non-Pediatrics
Olivia Floyd - AFLAC Oncology & Survivorship
Bobby Uddo - AFLAC Hematology
Amber Kaminski - AFLAC BMT & Developmental Therapeutics
Margo Kamel - Nephrology
Eric Hunter - Cystic Fibrosis
Linton Cuff - Endocrine
Kathy Stephens - Infectious Disease
Other
Emory Team - No Research Manager
Children's Team - No Research Manager
Research Manager Email (see below for reference):
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Study Team Contact/Coordinator Full Name:
Study Team Contact/Coordinator Email:
Emory Post-Award RAS Name:
Emory Post-Award RAS Email:
Is this an initial submission or resubmission (resubmission - an approver asked for clarification or study was denied)
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Initial submission
Resubmission
Is this a proposal?
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Yes
No
If yes, please only fill out form when funding has been granted. Please email researchfeasibility@choa.org if you need assistance.
If yes, please only fill out this form when funding has been granted. Please email researchfeasibility@choa.org if you need assistance.
Select the Department most appropriate for your project (choose only one):
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What specialty is the AFLAC study under?
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Oncology - Survivorship
Oncology - Comprehensive care
Oncology
Oncology - Survivorship & Comprehensive Care
Hematology - Biorepository & Precision Medicine
Hematology - Hemostasis & Thrombosis
Hematology - Sickle Cell
Hematology - General Hematology
Bone Marrow Transplant (BMT)
Developmental Therapeutics (DevT)
Epidemiology
Select the division most appropriate for your project:
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Allergy/Immunology
Anesthesiology
Cardiology/Cardiac
Cranofacial/Plastic Surgery
Cellular Therapy
Emergency Medicine
Ear Nose Throat (ENT)
Endocrinology
Gastrointestinal (GI)
General Pediatrics
Genetics
Hepatology
Immunology
Infectious Disease
Internal Medicine
Marcus Autism Center
Neonatology
Nephrology
Neurology
Neurosciences
Neonatal Intensive Care Unit (NICU)
Orthopedics
Pathology
Pediatric Intensive Care Unit (PICU)/Critical Care Medicine (CCM)
Public Health
Pulmonary/Asthma
Radiology
Rheumatology
Rollins School of Public Health
Sedation
Surgery
Technology-Dependent Intensive Care Unit (TICU)
Transplant
Trauma
Urology
Wellness
Other
Type of Study
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Clinical Trial - Investigative Drug
Clinical Trial - Investigative Device
Clinical Trial - Investigative Drug/Device
Clinical Trial - Investigative Non-Drug/Device
Clinical Trial - Social/Behavioral
Interventional Non-Drug/Device
Observational
Retrospective Chart Review
Not Human Subjects Research (NHSR)
Sponsor-Initiated (Industry), Single-Site Clinical Trial
Sponsor-Initiated (Industry), Multi-Site Clinical Trial
Investigator-Initiated (Industry), Clinical Trial, Single-Site, Sponsored
Investigator-Initiated (Industry), Clinical Trial, Multi-Site, Sponsored
Investigator-Initiated (Industry), Clinical Trial, Single-Site, Grant Funded
Investigator-Initiated (Industry), Clinical Trial, Multi-Site, Grant Funded
Investigator-Initiated (Industry), Clinical Trial, Single-Site, MCPCT Funded
Investigator-Initiated (Industry), Clinical Trial, Multi-Site, MCPCT Funded
Does this study involve the transfer of biological specimens collected from Children's patients to outside laboratories?
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Yes
No
Study Phase
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Pilot
Phase I
Phase II
Phase III
Phase IV
N/A
Will this study require the use of the multi-site clinical trials office?
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Yes
No
Enter Protocol Name or Number Provided by the Sponsor:
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Enter Project Short Title:
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Enter Project Full/Long Title:
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Has the IRB (Institutional Review Board) submission been started?
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Yes
No
If yes, which IRB was utilized:
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Children's Emory Other
If other, enter name of "Other" local or central IRB institution:
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Please provide the IRB number:
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Choose IRB (Institutional Review Board) institution
CHOA
EMORY
Other
If other, enter name of "Other" local IRB or central IRB institution that will be used:
Is this a study that will enroll subjects?
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Yes
No
Does this study potentially provide care/research interventions to an injured patient?
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Yes
No
Will cells be manufactured in an Emory or CHOA GMP facility?
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Yes
No
If no, describe outside facility where cells will be manufactured and the plan for shipping and storing the cells on site:
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Has the GMP lab director been notified?
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Yes
No
Have validation runs been planned or completed?
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Yes
No
Is cell product and/or technology developed by Emory/Children's/GT or an outside facility or lab?
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Yes (Emory/Children's/GT)
Yes (outside facility or lab)
No
Does CHOA or Emory own the IP?
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Yes
No
No, but possible
Is the study a novel/innovative strategy developed by Emory and/or Children's faculty?
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Yes
No
Is the study an Industry owned IP (Industry benefits from the study) or an Industry Sponsored study?
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Industry owned IP
Industry Sponsored Study
How does the proposal advance the reputation of CHOA or Emory Department of Pediatrics in the cell therapy community?
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Has this project been discussed for scientific merit by the research director/lead assigned by your department? (Research lead may be the division director in some departments)
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Yes
No
Research lead may be the division director in some departments
If no, select reason:
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I will go back to discuss with the director(s) to discuss for scientific merit to complete this form
Other reason: (please enter reason below)
Enter explanation below:
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Who from your division (or research director/lead) have you discussed this study with? (Some research directors or leads may be the division director. If you are a non-AFLAC director, please select the option to route to PRCC review. for AFLAC directors, please select the option of AFLAC Division Directors review. You will not be able to approve your own study.)
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Cardiology - Bill Mahle Neonatology - Brenda Poindexter Rheumatology - Sampath Prahalad Endocrinology - Andrew Muir GI - Cary Sauer Neurology - David Wolf Neurosurgery - Joshua Chern Nephrology - Larry Greenbaum ID - Andi Shane Gen Peds - Hughes Evans CCM - Jocelyn Grunwell LOBP - Raymond Schinazi PACS - Dawn Simon Marcus - Ami Klin Hospitalists - Corinne Taylor Radiology - Erica Riedesel Palliative Care - Khaliah Johnson ED - Claudia Morris Cell Therapy - Edwin Horwitz Aflac L/L - Sharon Castellino Aflac ST - Thomas Cash Aflac DevT - Jason Fangusaro Aflac BT - Toby MacDonald Aflac Survivor/Comprehensive Care - Jordan Marchak Aflac BMT - Muna Qayed Aflac Oncology (other) - Dan Wechsler Aflac GenHeme- Jeanne Boudreaux Aflac H&T- Robert Sidonio Aflac Sickle Cell - Carlton Dampier Allergy/Immunology - Brian Vickery Ear Nose Throat (ENT) - Steve Goudy Hepatology - Cary Sauer Immunology - Brian Vickery Neurosciences - David Wolf Neonatal Intensive Care Unit (NICU) - Ravi Patel Pathology - Elizabeth Weinzierl Pulmonary/Asthma - Nael McCarty Surgery - Matt Clifton Clinical Informatics - Evan Orenstein Cranofacial/Plastic Surgery, Genetics, Internal Medicine, Orthopedics, Public Health, Rollins School of Public Health, and any Division Director studies - Sarah Marie Huban Behavioral & Mental Health - John Constantino Orthopaedics - Michael Schmitz
Please provide the email address of the research director/lead from your division that was notified (name listed above):
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If the division (or research director/lead) is the same as the PI, for Non-Aflac studies please list the email of Sarah Marie Huban (sarah.marie.huban@emory.edu) for review and approval and for Aflac studies, please list Robert Sidonio (robert.sidonio.jr@emory.edu) or Anna Mertens (Ann.Mertens@choa.org)
Are other subspecialties/services involved in this project? (Examples of subspecialties: Consults from different departments such as psychology, neurology, aerodigestive, emergency)
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Yes
No
If the previous question was marked yes, make sure to discuss with departments.
Enter funding information (check all that apply):
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Enter "other" option:
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Is this a Children's Oncology Group (COG) study?
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Yes
No
Does the study team have a financial or other conflict of interest related to the study?
(A conflict of interest is a situation in which financial or other personal consideration have the potential to compromise or bias professional judgement and objectivity.)
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Yes
No
A conflict of interest is a situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity.
If federally funded through Emory IRB, reach out to the conflict of interest department (http://www.coi.emory.edu/) and complete this form : (http://www.coi.emory.edu/documents/External%20COI%20Form.pdf).
Has this form been completed?
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Yes
No
What is the estimated duration of the project?
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Please specify years/months/etc.
Is the project time sensitive?
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Yes
No
Please explain
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Briefly describe the importance of this project to the program and/or investigator.
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Is there potential for Emory and/or Children's faculty to be the first or senior author and/or lead enroller?
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Yes
No
Maybe
Does this project benefit patients in a unique way?
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Yes
No
Briefly explain:
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Are you recruiting non-English patients into your research protocol?
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Yes
No
If no, provide reason for exclusion:
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Please specify language(s):
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Specific language(s) for other:
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Will you be using a short form consent and translators provided by CHOA or Emory?
(A short form consent is used to enroll participants with limited English proficiency (LEP) into a research study when a
version of the consent form translated into the participant's language is not available. A short form is intended to
allow the enrollment of LEP participants when it was unexpected that such a language would be necessary.)
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Yes
No
A short form consent is used to enroll participants with limited English proficiency (LEP) into a research study when a version of the consent form translated into the participant's language is not available. A short form is intended to allow the enrollment of LEP participants when it was unexpected that such a language would be necessary.
Are you aware of competing trials ongoing at Children's and/or Emory?
(i.e., trials with overlapping eligibility)
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Yes
No
i.e., trials with overlapping eligibility
Please list out competing trials. Explain how potential participants will be prioritized between the proposed study and current competing trials:
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Is this study a funded chart review?
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Yes
No
Yes
No
Will your study require participation by clinical care teams?
Yes
No
Clinical care team includes nurses, personnel to conduct special procedures, and unit supplies
Are the unit supplies required for this study?
Yes
No
If yes, please confirm you have had a discussion with those teams:
Are the unit nurses required for this study?
Yes
No
If yes, please confirm you have had a discussion with those teams:
Are other personnel required to conduct special procedures or efficacy measures?
Yes
No
Have you had discussion with those teams?
Yes
No
Will special procedures require evaluations or testing outside of regular clinic hours?
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Yes
No
Are there Bucket charges associated with this study?
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Yes
No
How many participants does the sponsor expect to enroll at Children's and/or Emory?
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How many participants does the sponsor expect to enroll at Children's and/or Emory per year?
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Where will you enroll/treat participants? (check all that apply)
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check all that apply
If other, please clarify:
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What is the source of patients?
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If other, please explain
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Will there be a patient stipend/compensation to pay study participants?
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Yes
No
If yes, which method will be used to reimburse?
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CHOA ClinCard
Emory ClinCard
Sponsor ClinCard
Gift Cards
Other:
If you will be using Emory clincards or sponsor provided clincards, please select other
If other, please clarify
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Are you planning on using an Emory and/or Children's coordinator team for this project?
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Yes
No
Is the coordinator/coordinating team from CHOA or Emory?
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CHOA
Emory
Both
The option " " can only be selected by itself. Selecting this option will clear your previous selections for this checkbox field. Are you sure?
Are staff hours required outside of their standard work schedule?
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outside of standard work schedule examples: weekends, after 5pm evening shifts, on-call
If yes, provide an estimate of FTE or part-time staff required to conduct the study
Is there special equipment that will need to be provided to conduct the study that is not being provided by CHOA or Emory?
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Yes
No
If yes, will sponsor be providing the equipment or has funding been provided for this equipment?
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Yes
No
If no, please provide details on equipment needed/where equipment/funding is coming from:
Does the study require DSMB review?
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Yes
No
The option " " can only be selected by itself. Selecting this option will clear your previous selections for this checkbox field. Are you sure?
What Ancillary Services/Departments will be required? (Check all that apply)
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Note: You have selected the Pediatric Research Unit (PRU) as an ancillary department. All studies utilizing the PRU require EPIC order sets. Select "Yes" regarding EPIC requirements above:
Emory Billable Services - Please Explain:
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Enter "Other" option:
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"Investigational Pharmacy Services" not selected for investigative drug trial - please explain:
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e.g. "Emory IDS dispensing" or "Sponsor ships drug directly to patients"
Ancillary Notes:
Laboratory Procedures and Services include:Research Processing Laboratory/Advanced Diagnostics Histology/Pathology Chemistry and Hematology (Local Processing) Blood Bank Coag (Local Processing) Phlebotomy Other
Health Informatics Core services include:Data Extraction Reporting Epic Builds and Reporting Workbench Human-Centered Design Data Engineering Software Engineering Research Business Partnering services includes:Order Sets BPAs Campaigns
REDCap (CHOA)/Research Business Partnering/Health Informatics Core Fee Schedule
Will you need assistance with REDCap development?
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Yes
No
Which locations will receive investigational medication from IDS?
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Please download this radiology form, complete, and re-upload completed radiology form in the documents at the end of the form. *THIS FORM IS REQUIRED IF YOU ARE USING RADIOLOGY ANCILLARY DEPARTMENT.
If you are using CIRC, please select what you will need below:
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Will you require any of these lab services? (Check all that apply)
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"Laboratory Procedures and Services", "Research Processing" or "Histology/Pathology" not selected for study involving biological specimen transfer to outside lab - please explain:
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e.g. "Study coordinator staff will collect and ship specimens directly"
Please explain, other:
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What space and services will you require at Hughes Spalding for this study?
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Please explain:
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Available protocol (final version required):
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Additional available protocol/protocol team review (if applicable):
Draft of the informed consent form:
Draft of additional informed consent form:
additional upload fields will appear after entry
Draft of additional informed consent form:
Draft of additional informed consent form:
Draft of additional informed consent form:
Draft of additional informed consent form:
Draft of additional informed consent form:
Draft of additional informed consent form:
Available contract or award (draft is acceptable):
If unfunded, may not be applicable
Available budget (draft is acceptable):
If unfunded, may not be applicable
Children's Letter of Intent (LOI):
FDA communication such as IND or IDE letter (if applicable):
Radiology/Imaging Manual (if applicable):
Radiology Forms (Required if Radiology is selected as an ancillary department):
* must provide value
For Divisions that require additional information. Please request from your division research leadership if applicable
Laboratory Manual (if applicable):
Pharmacy Manual (if applicable):
Investigational Drug Brochure/Investigator Brochure (if applicable):
Additional ancillary department forms:
Please upload any document that you would like to provide that has not already been uploaded above:
Please upload any document that you would like to provide that has not already been uploaded above:
Please upload any document that you would like to provide that has not already been uploaded above:
Please upload any document that you would like to provide that has not already been uploaded above:
Please upload any document that you would like to provide that has not already been uploaded above:
Comments/additional information:
Principal Investigator Phone Number:
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Study Team Contact/Coordinator Phone Number:
If other, please clarify:
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What specialty is the AFLAC study under?
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Hematology - (including Biorepository, Hemostatis and Thrombosis, Precision Medicine, Sickle Cell)
Oncology - (including Survivorship & Comprehensive Care, Developmental Therapeutics)
Bone Marrow Transplant
Hematology - (including Biorepository, Hemostasis and Thrombosis, Precision Medicine, Sickle Cell, Gen Hem)
Oncology - (including Survivorship & Comprehensive Care)
Bone Marrow Transplant/Developmental Therapeutics
Clinical Trials Coordination
Other
If other, please clarify
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Enter Name of Research Manager
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Cheryl Stone - Pediatric Research Unit (PRU)
Kaitlin Jones - Egleston
Rebecca Cleeton - Center for Advanced Pediatrics (CAP)
Marco Benoit - Scottish Rite/Hughes Spalding
Jodi Salim - Marcus Autism
Ansley Reich - Marcus Autism
Sarah Marie Huban - Emory Department of Pediatrics
Sarah Marie Huban - Emory Non-Pediatrics
Amanda Sanders - AFLAC Oncology
Kenya Jackson - AFLAC Hematology
Stacey Brown - AFLAC Hematology
Bobby Uddo - AFLAC Hematology
Olivia Floyd - AFLAC Oncology
Amber Kaminski - AFLAC BMT & Developmental Therapeutics
Margo Kamel - Nephrology
Eric Hunter - Cystic Fibrosis
Linton Cuff - Endocrine
Kathy Stephens - Infectious Disease
Other
Enter "Other" Name
* must provide value
Have you discussed this study with the research manager?
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Yes
No - I will go back to discuss with the research manager before continuing this form.
Type of Clinical Trial:
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Sponsor-Initiated (Industry), Single-Site Clinical Trial
Sponsor-Initiated (Industry), Multi-Site Clinical Trial
Investigator-Initiated (Industry), Clinical Trial, Single-Site, Sponsored
Investigator-Initiated (Industry), Clinical Trial, Multi-Site, Sponsored
Investigator-Initiated (Industry), Clinical Trial, Single-Site, Grant Funded
Investigator-Initiated (Industry), Clinical Trial, Multi-Site, Grant Funded
Investigator-Initiated (Industry), Clinical Trial, Single-Site, MCPCT Funded
Investigator-Initiated (Industry), Clinical Trial, Multi-Site, MCPCT Funded
Choose IRB institution (Institutional Review Board)
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Is the proposal based on science developed at CHOA/Emory (home grown science)?
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Yes
No
Refer to this diagram to assist in answering the next question on which IRB will be used (Emory vs CHOA). If a central IRB is being used, please disregard this diagram.
Enter IRB Number if it has been started (if not started please leave blank):
Will an IBC review be required?
Yes
No
Who from your division (or research director/lead) have you discussed this study with?
* must provide value
Cardiology - Bill Mahle Neonatology - Brenda Poindexter Rheumatology - Sampath Prahalad Endocrinology - Andrew Muir GI - Cary Sauer Neurology - David Wolf Nephrology - Larry Greenbaum ID - Andi Shane Gen Peds - Hughes Evans CCM - Jocelyn Grunwell LOBP - Raymond Schinazi PACS - Dawn Simon Marcus - Ami Klin Hospitalists - Corinne Taylor Radiology - Erica Riedesal Palliative Care - Khaliah Johnson ED - Claudia Morris Cell Therapy - Edwin Horwitz Aflac L/L - Sharon Castellino Aflac ST - Thomas Cash Aflac DevT - Jason Fangusaro Aflac BT - Toby MacDonald Aflac Survivor/Comprehensive Care - Ann Mertens Aflac BMT - Muna Qayed Aflac Oncology (other) - Dan Wechsler Aflac GenHeme- Jeanne Boudreaux Aflac H&T- Robert Sidonio Aflac Sickle Cell- Beatrice Gee AFLAC division directors - Douglas Graham Allergy/Immunology - Brian Vickery Ear Nose Throat (ENT) - Steve Goudy Hepatology - Cary Sauer Immunology - Brian Vickery Neurosciences - Tim Gershon Neonatal Intensive Care Unit (NICU) - Ravi Patel Pathology - Beverly Rogers Pulmonary/Asthma - Nael McCarty Surgery - Matt Clifton Clinical Informatics - Evan Orenstein Anesthesiology, Cranofacial/Plastic Surgery, Genetics, Internal Medicine, Orthopedics, Public Health, Rollins School of Public Health, and any Division Director studies - PRCC (Sarah Marie Huban) Funded Proposal/LOI Completed (FOR RESEARCH ADMIN ONLY)
If yes, have you discussed the project with these subspecialties/services?
* must provide value
Yes
No
List department and names of appropriate person(s) for each subspecialty/service:
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Do you need assistance in contacting the appropriate person(s)?
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Yes
No
If no, please explain:
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Type of Study
* must provide value
Clinical Trial - Investigative Drug Clinical Trial - Investigative Device Clinical Trial - Investigative Drug/Device Clinical Trial - Investigative Non-Drug/Device Clinical Trial - Social/Behavioral Interventional Non-Drug/Device Observational Retrospective Chart Review
Study Phase
* must provide value
Pilot Phase I Phase II Phase III Phase IV Post Marketing N/A
Has a biostatistician reviewed and approved adequate power calculation study size?
* must provide value
Yes
No
N/A
What is the estimated number of patients who meet the inclusion criteria based off of biostatistician review?
Has the coordinator team already been identified?
Yes
No
If yes, is the coordinator time expected to be included in the budget?
Yes
No
If no, please indicate alternative funding source for coordinator time:
Volunteer
Internal Department coordinator pool
Other
Enter "Other" Name
* must provide value
Aflac BMT
Aflac Developmental Therapeutics
Aflac General Hematology
Aflac Hemostasis & Thrombosis
Aflac Oncology
Aflac Sickle Cell Disease
Aflac Survivorship
Anesthesiology
Cardiac-Cardiology
Cardiac-Cardiothoracic Surgery
Cardiac-CIRC
Chief Nurse Executive
Craniofacial/Plastic Surgery
Critical Care Medicine
Endocrine
ENT
GI
General Pediatrics
General Surgery
Hepatology
Infectious Disease
Marcus-Behavior Analysis Research
Marcus-Clinical Trials
Marcus-Device
Marcus-Educational Science Core
Marcus-Feeding
Marcus-Genetics
Marcus-Infant Toddler Community Outreach
Marcus-Neuroimaging
Marcus-Research Operations/Clinical Assessment Core
Marcus-Social Neuroscience
Marcus-Spoken Communication
Neonatology
Nephrology
Neurology
Neuropsychology
Neurosciences
Neurosurgery
Ortho-Brachial Plexus
Ortho-Concussion
Ortho-Fracture Care
Ortho-General Orthopedics
Ortho-Orthotics & Prosthetics
Ortho-Scoliosis
Orthopedics
PACS-Allergy/Immunology
PACS-Asthma
PACS-Cystic Fibrosis
PACS Pulmonology
Pathology
Public Health
Radiology
Rehab
Rheumatology
Urology
Wellness
Other
Completed Survey (DO NOT ATTACH ANY DOCUMENTS)
Date Subcontract received by Children's Research Administration
Today D-M-Y
Date Emory Prime agreement executed/awarded
Today D-M-Y
Federal
Industry
Foundation
Internal
Other
Chain of Funding (if applicable):
If other, please clarify:
Submit
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