Survey Date (auto populates, not seen on public survey)
Today M-D-Y
Enter Name of Person Submitting Form:
* must provide value
Enter email address of person submitting the form:
* must provide value
Is this an initial submission or resubmission (resubmission - an approver asked for clarification or study was denied)
* must provide value
Initial submission
Resubmission
Is this a proposal?
* must provide value
Yes
No
If yes, please only fill out this form when funding has been granted. Please email researchfeasibility@choa.org if you need assistance.
Select the Division(s) most appropriate for your project (i.e., where participants will be recruited from):
* must provide value
If other, please clarify:
* must provide value
Does this study potentially provide care/research interventions to an injured patient?
* must provide value
Yes
No
What specialty is the AFLAC study under?
* must provide value
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
* must provide value
Type of Clinical Trial:
* must provide value
Sponsor-Initiated (Industry), Single-Site Clinical Trial
Sponsor-Initiated (Industry), Multi-Site Clinical Trial
Investigator-Initiated, Clinical Trial, Single-Site, Sponsored
Investigator-Initiated, Clinical Trial, Multi-Site, Sponsored
Investigator-Initated, Clinical Trial, Single-Site, Grant Funded
Investigator-Initiated, Clinical Trial, Multi-Site, Grant Funded
Investigator-Initiated, Clinical Trial, Single Site, MCPCT Funded
Investigator-Initiated, Clinical Trial, Multi Site, MCPCT Funded
Will cells be manufactured in an Emory or CHOA GMP facility?
* must provide value
Yes
No
If no, describe outside facility where cells will be manufactured and the plan for shipping and storing the cells on site:
* must provide value
Has the GMP lab director been notified?
* must provide value
Yes
No
Have validation runs been planned or completed?
* must provide value
Yes
No
Is cell product and/or technology developed by Emory/Children's/GT or an outside facility or lab?
* must provide value
Yes (Emory/Children's/GT)
Yes (outside facility or lab)
No
Does CHOA or Emory own the IP?
* must provide value
Yes
No
No, but possible
Is the study a novel/innovative strategy developed by Emory and/or Children's faculty?
* must provide value
Yes
No
Is the study an Industry owned IP (Industry benefits from the study) or an Industry Sponsored study?
* must provide value
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?
* must provide value
Is the proposal based on science developed at CHOA/Emory (home grown science)?
* must provide value
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.
Choose IRB institution (Institutional Review Board)
* must provide value
Enter name of "Other" local IRB or central IRB institution that will be used:
* must provide value
Enter IRB Number if it has been started (if not started please leave blank):
Will an IBC review be required?
Yes
No
EPEX ID (if n/a please leave blank)
Enter Protocol Name or Number Provided by the Sponsor:
* must provide value
Enter Project Short Title:
* must provide value
Enter Project Full/Long Title:
* must provide value
Principal Investigator Full Name:
* must provide value
Principal Investigator Email:
* must provide value
Principal Investigator Phone Number:
* must provide value
Enter Name of Research Manager
* must provide value
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
Other
Enter "Other" Name
* must provide value
Have you discussed this study with the research manager?
* must provide value
Yes
No - I will go back to discuss with the research manager before continuing this form.
Study Team Contact/Coordinator Full Name:
Study Team Contact/Coordinator Email:
Study Team Contact/Coordinator Phone Number:
Is this a study that will enroll subjects?
* must provide value
Yes
No
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 this project been discussed for scientific merit by the research director/lead assigned by your department?
* must provide value
Yes
No
Research lead may be the division director in some departments
If no, select reason:
* must provide value
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:
* must provide value
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 - Saul Karpen Neurology - David Wolf Nephrology - Larry Greenbaum ID - Andi Shane Gen Peds - Hughes Evans CCM - Jocelyn Grunwell LOBP - Raymond Schinazi PACS - Arlene Stecenko 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 - Saul Karpen Immunology - Brian Vickery Neurosciences - Tim Gershon Neonatal Intensive Care Unit (NICU) - Ravi Patel Pathology - Beverly Rogers Pulmonary/Asthma - Nael McCarty Surgery - Matt Clifton Anesthesiology, Cranofacial/Plastic Surgery, Genetics, Internal Medicine, Orthopedics, Public Health, Rollins School of Public Health, and any Division Director studies - PRCC (Sarah Marie Huban)
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.
Provide email of the research director/lead from your division that was notified (name listed above):
* must provide value
If you are a non-AFLAC division director, please input the email of Sarah Marie Huban who will route to PRCC review (sarah.marie.huban@emory.edu). You will not be able to approve your own study. If you are an AFLAC director, please enter the email of Dr. Douglas Graham.
Are other subspecialties/services involved in this project? (Examples of subspecialties: Consults from different departments such as psychology, neurology, aerodigestive, emergency)
* must provide value
Yes
No
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:
* must provide value
Do you need assistance in contacting the appropriate person(s)?
* must provide value
Yes
No
If no, please explain:
* must provide value
Enter funding information (check all that apply):
* must provide value
Enter "other" option:
* must provide value
Does the study team have a financial or other conflict of interest related to the study?
* must provide value
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).
* must provide value
Yes
No
What is the estimated duration of the project?
* must provide value
Is the project time sensitive (ex. competitive enrollment, flu season, covid variant)?
* must provide value
Yes
No
Please explain
* must provide value
Briefly describe the importance of this project to the program and/or investigator.
* must provide value
Is there potential for Emory and/or Children's faculty to be the first or senior author and/or lead enroller?
* must provide value
Yes
No
Maybe
Does this project benefit patients in a unique way?
* must provide value
Yes
No
Briefly explain:
* must provide value
Are you recruiting non-English patients into your research protocol?
* must provide value
Yes
No
If no, provide reason for exclusion:
* must provide value
Please specify language(s):
* must provide value
Specific language(s) for other:
* must provide value
Will you be using a short form consent and translators provided by CHOA or Emory?
* must provide value
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?
* must provide value
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:
* must provide value
Is this study a funded chart review?
* must provide value
Yes
No
If yes to funded chart review, skip the "additional resources" and "research staff and resources" sections. Please fill out the enrollment, locations, monitoring & ancillary departments, and documents sections.
Is an EPIC order set build needed for this study?
Yes
No
The order set will be uploaded via IS&T (https://choaproduction.service-now.com/sp) the EPIC team and all study orders will be "built" into the EPIC system. For inpatient studies, the approved order set will be uploaded via IS&T (https://choaproduction.service-now.com/sp) the EPIC team and all study orders will be "built" into the EPIC system. An EPIC build is expected in approximately 30 days. Please email researchtechnology@choa.org for any questions.
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
Will special procedures require evaluations or testing outside of regular clinic hours?
Yes
No
Have you had discussion with those teams?
Yes
No
How many participants does the sponsor expect to enroll at Children's and/or Emory?
* must provide value
How many participants does the sponsor expect to enroll at Children's and/or Emory per year?
* must provide value
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?
Where will you enroll/treat participants? (check all that apply)
* must provide value
check all that apply
If other, please clarify:
* must provide value
What is the source of patients?
* must provide value
If other, please explain
* must provide value
Will there be a patient stipend/compensation to pay study participants?
* must provide value
Yes
No
If yes, which method will be used to reimburse?
* must provide value
CHOA clincard
other:
If you will be using Emory clincards or sponsor provided clincards, please select other
If other, please clarify
* must provide value
Are you planning on using an Emory and/or Children's coordinator team for this project?
Yes
No
Is the coordinator/coordinating team from CHOA or Emory?
CHOA
Emory
Both
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
Are staff hours required outside of their standard work schedule?
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?
Yes
No
If yes, will sponsor be providing the equipment or has funding been provided for this equipment?
Yes
No
If no, please provide details on equipment needed
Does the study require DSMB review?
* must provide value
Yes
No
What Ancillary Services/Departments will be required? (Check all that apply)
* must provide value
Enter "Other" option:
* must provide value
Which locations will receive investigational medication from IDS?
* must provide value
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:
* must provide value
Will you require any of these lab services? (Check all that apply)
* must provide value
Please explain, other:
* must provide value
What space and services will you require at Hughes Spalding for this study?
* must provide value
Please explain:
* must provide value
Will you need assistance with REDCap development?
* must provide value
Yes
No
Please upload available protocol (final version required):
* must provide value
Please upload any additional available protocol (final version required) if applicable:
Please upload draft of the informed consent form:
Please upload draft of additional informed consent form:
Please upload draft of additional informed consent form:
Please upload draft of additional informed consent form:
Please upload draft of additional informed consent form:
Please upload draft of additional informed consent form:
Please upload draft of additional informed consent form:
Please upload draft of additional informed consent form:
Please upload available contract or award (draft is acceptable):
If unfunded, may not be applicable
Please upload available budget (draft is acceptable):
If unfunded, may not be applicable
Please upload any FDA communication such as IND or IDE letter: (if applicable)
Please upload Radiology/Imaging Manual (if applicable):
Please upload Laboratory Manual (if applicable):
Please upload Pharmacy Manual (if applicable):
Please upload Investigational Drug Brochure/Investigator Brochure (if applicable):
Please upload 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
Please upload any 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:
Completed Survey (DO NOT ATTACH ANY DOCUMENTS)
Comments/additional information:
Submit
Save & Return Later
