The code block below illustrates how one might use # and // as comments in your logic and calculations.

# Text can be put here to explain what the logic/calculation does and why.
if ([field1] = '1' and [field2] > 7,

	// This comment can explain what the next line does.
	[score] * [factor],

	// Return '0' if the condition is False.
	0
)

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Clinical Research Feasibility Review

Feasibility Review is required for new sponsored studies (industry, federal, consortium, investigator-initiated, and internally funded). Upon feasibility review approval, the budget (including coverage analysis), contracts, and IRB reviews may occur in parallel. Any studies that will require Emory services or sub-contracting will still need to submit into PRISM and Emory's Intent to Submit form after Feasibility approval.

The study team (research coordinator, regulatory coordinator, and/or PI), after discussion with the research manager, compiles essential study documents (i.e., final protocol, draft consents, available budget templates, radiology or laboratory manuals, pharmacy manuals, investigational drug brochures, competed ancillary department forms, and any additional pertinent documents) to submit with Feasibility Review Form.

It is the study team's responsibility to complete and submit this Feasibility Review Form.

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The option "" can only be selected by itself. Selecting this option will clear your previous selections for this checkbox field. Are you sure?

Survey Date (auto populates, not seen on public survey)

M-D-Y

Who is submitting the feasibility form?

* must provide value

Study Team

Research Admin Team

Enter Name of Person Submitting Form:

* must provide value

Enter email address of person submitting the form:

* must provide value

Principal Investigator Full Name:

* must provide value

Principal Investigator Email:

* must provide value

Select Name of Research Manager

* must provide value

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

Olivia Floyd - AFLAC Oncology & Survivorship

Bobby Uddo - AFLAC Hematology

Amber Kaminski - AFLAC BMT & Developmental Therapeutics

Emory Team - No Research Manager

Children's Team - No Research Manager

Research Manager Email (see below for reference):

* must provide value

Research Managers: Email

Benoit, Marco - Macarthur.Benoit@choa.org

Cleeton, Rebecca - Rebecca.Cleeton@choa.org

Floyd, Olivia - Olivia.Floyd@choa.org

Jones, Kaitlin - Kaitlin.Jones@choa.org

Kaminski, Amber - Amber.Kaminski@choa.org

Reich, Ansley - Ansley.Reich@choa.org

Uddo, Bobby - Robert.Uddo@choa.org

Van Dresser, Morgan - Morgan.Vandresser@choa.org

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)

* 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

Aflac

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

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

What specialty is the AFLAC study under?

* must provide value

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

Type of Study

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

Type of Clinical Trial:

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?

* must provide value

Yes

No

Study Phase

Pilot

Phase I

Phase II

Phase III

Phase IV

N/A

Will this study require the use of the multi-site clinical trials office?

Yes

No

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

Choose IRB (Institutional Review Board) institution

* must provide value

CHOA

EMORY

Other

If other, enter name of "Other" local IRB or central IRB institution that will be used:

* must provide value

Is this a study that will enroll subjects?

* must provide value

Yes

No

Does this study potentially provide care/research interventions to an injured patient?

* must provide value

Yes

No

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

Expand

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

Expand

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)

* must provide value

Yes

No

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

Expand

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.)

* must provide value

Please provide the email address of the research director/lead from your division that was notified (name listed above):

* must provide value

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 the previous question was marked yes, make sure to discuss with departments.

Enter funding information (check all that apply):

* must provide value

Industry

Federal

Foundation

Other Institution/University

Investigator Self-Funded (e.g., discretionary, start-up funds)

Institutionally/Internally Funded (e.g., Emory or CHOA pilot award)

Consortium, Federal

Consortium, Foundation

Other

Enter "other" option:

* must provide value

Is this a Children's Oncology Group (COG) study?

* must provide value

Yes

No

Enter Prime Sponsor Name:

Enter Direct Sponsor Name:

Enter Sponsor Information:

Enter Sponsor Contact's Name (if available):

Enter Sponsor Contact's Email (if available):

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.)

* must provide value

Yes

No

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?

* must provide value

Yes

No

What is the estimated duration of the project?

* must provide value

Is the project time sensitive?

* must provide value

Yes

No

Please explain

* must provide value

Expand

Briefly describe the importance of this project to the program and/or investigator.

* must provide value

Expand

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

Expand

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

Spanish

Other

Specific language(s) for other:

* must provide value

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.)

* must provide value

Yes

No

Are you aware of competing trials ongoing at Children's and/or Emory?

(i.e., trials with overlapping eligibility)

* must provide value

Yes

No

Please list out competing trials. Explain how potential participants will be prioritized between the proposed study and current competing trials:

* must provide value

Expand

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.

Note: You have selected the Pediatric Research Unit (PRU) as an ancillary department. All studies utilizing the PRU require EPIC order sets. Select "Yes" below:

Is an EPIC order set build needed for this study?

(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.)

Yes

No

Will your study require participation by clinical care teams?

Yes

No

Are the unit supplies required for this study?

Yes

No

If yes, please confirm you have had a discussion with those teams:

If no, please explain:

Are the unit nurses required for this study?

Yes

No

If yes, please confirm you have had a discussion with those teams:

If no, please explain:

Are other personnel required to conduct special procedures or efficacy measures?

Yes

No

Have you had discussion with those teams?

Yes

No

If no, please explain:

Will special procedures require evaluations or testing outside of regular clinic hours?

Yes

No

Are there Bucket charges associated with this study?

Yes

No

If yes, please provide.

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

Where will you enroll/treat participants? (check all that apply)

* must provide value

Pediatric Research Unit (PRU)

Egleston

Scottish Rite

Marcus Autism Center

Hughes Spalding

Center for Advanced Pediatrics (CAP)

Emory Children's Center Research Unit (ECC-RU)

Emory Midtown

Grady

Hope Clinic

NDH Clinic, North Druid HIlls

Private Practice

Scottish Rite MOB

Wesley Woods

Other

If other, please clarify:

* must provide value

What is the source of patients?

* must provide value

Clinic/Outpatient

Preadmission

Testing

Inpatient

Emergency Department/Urgent Care

NICU/PICU/CICU

Community

Chart Review

Other

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

Emory ClinCard

Sponsor ClinCard

Gift Cards

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

Are staff hours required outside of their standard work schedule?

Yes

Possible (PK samples, research samples, timing, etc)

Possible (Drug Dispensing from IDS)

No

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/where equipment/funding is coming from:

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

None

Investigational Pharmacy Services

Pediatric Research Center (PRU)

Cardiovascular Imaging Research Core (CIRC)

Pediatric Procedural Sedation Services

Surgical Services

Laboratory Procedures and Services

Rehabilitation Services

Radiology Services

REDCap Services (CHOA)

Research Business Partnering

Health Informatics Core

Advanced Analytics

Brain Health Center

Cellular Therapies Lab

Apheresis

Eye Exam

Other

Select if you are using Hughes Spalding as a site

Enter "Other" option:

* must provide value

"Investigational Pharmacy Services" not selected for investigative drug trial - please explain:

* must provide value

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?

* must provide value

Yes

No

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.

Attachment:Protocol review form version 7.0 .docx

If you are using CIRC, please select what you will need below:

* must provide value

ECG

ECG in Medical Record/Needs to be read (will include pro fees)

Echo

Echo in Medical Record/Needs to be read (will include pro fees)

Coordinator Training for staff

Sonographer Training for staff

Echo Discs and/or data uploaded to online portal

Echo Discs de-identified and/or data uploaded to online portal

Will you require any of these lab services? (Check all that apply)

* must provide value

Research Processing Laboratory/Advanced Diagnostics

HIstology/Pathology

Chemistry and Hematology

Blood Bank

Coag

Phlebotomy

Other

"Laboratory Procedures and Services", "Research Processing" or "Histology/Pathology" not selected for study involving biological specimen transfer to outside lab - please explain:

* 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

Research Visit Space

Work Space for Non-Children's Employee

Storage of Supplies/Binders

Specimen Storage Space

Physician Orders Required for Research Drugs, Procedures, or Tests

Pharmacy Services

Laboratory Services

Non-Invasive Cardiology

Respiratory Services

Radiology Services

Please explain:

* must provide value

Expand

Final Protocol

Available protocol (final version required):

* must provide value

Additional available protocol/protocol team review (if applicable):

Consent Documents

Draft of the 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:

Draft of additional informed consent form:

Draft of additional informed consent form:

Contract/Award Documents

Available contract or award (draft is acceptable):

Available budget (draft is acceptable):

Children's Letter of Intent (LOI):

Sponsor instructions/correspondence/agreements (draft is acceptable):

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

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:

Expand

Principal Investigator Phone Number:

* must provide value

Study Team Contact/Coordinator Phone Number:

If other, please clarify:

* must provide value

What specialty is the AFLAC study under?

* must provide value

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

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

Ansley Reich - Marcus Autism

Sarah Marie Huban - Emory Department of Pediatrics

Sarah Marie Huban - Emory Non-Pediatrics

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?

* must provide value

Yes

No - I will go back to discuss with the research manager before continuing this form.

Type of Clinical Trial:

* must provide value

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)

* must provide value

CHOA

EMORY

OTHER - SPECIFY

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.

Attachment:Childrens Emory Routing Flow 05192022.pdf

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

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

Type of Study

* must provide value

Study Phase

* must provide value

Please clarify "other" option:

* 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?

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

If other, please specify

Enter "Other" Name

* must provide value

PI Department

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)

EPEX Number:

Date Subcontract received by Children's Research Administration

D-M-Y

Date Emory Prime agreement executed/awarded

D-M-Y

Type of Funding

Federal

Industry

Foundation

Internal

Other

Chain of Funding (if applicable):

If other, please clarify:

You have selected an option that triggers this survey to end right now.

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