Notes
List ideas for Improvement here
What Stage is the Study?
How did you hear about us?
New SAC application
Grant proposal budget only
SAC Approved
Study on Hold
Closed
New SAC application
Grant proposal budget only
SAC Approved
Study on Hold
Closed
Please complete the application
Organize a Roundtable
Patient Enrollment Reminder
On Hold: Any Changes?
We are closing your study
Please complete the application
Organize a Roundtable
Patient Enrollment Reminder
On Hold: Any Changes?
We are closing your study
How did you hear about us?
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Principal Investigator Name
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Principal Investigator Title (Professor, Associate Professor, etc.)
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Yes
No
An Investigator at the Assistant Professor, Instructor, Postdoctoral, Predoctoral or College Level. Please note, to be considered, Assistant Professors must NOT have previously been awarded an NIH R01 or equivalent federal grant (i.e. VA Merit Award, etc.).
Principal Investigator Institute Affiliation
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Emory University Children's Healthcare of Atlanta Morehouse School of Medicine University of Georgia Georgia Institute of Technology
Principal Investigator School Affiliation
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School of Medicine School of Nursing School of Public Health Emory College
Please select department
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Anesthesiology Biochemistry Biomedical Engineering Biomedical Informatics Cell Biology Dermatology Emergency Medicine Family & Preventative Medicine Gynecology / Obstetrics Hematology / Medical Oncology Human Genetics Medicine Microbiology / Immunology Neurology Neurosurgery Ophthalmology Orthopedics Otolaryngology Pathology & Laboratory Medicine Pediatrics Pharmacology & Chemical Biology Physiology Psychiatry & Behavioral Sciences Radiation Oncology Radiology & Imaging Sciences Rehabilitation Medicine Surgery Urology
Please select division
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Cardiology Digestive Diseases Endocrinology General Medicine Geriatrics and Gerontology Hospital Medicine Infectious Diseases Pulmonary, Allery, Critical Care, and Sleep Medicine Renal Medicine Rheumatology
Please specify
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Principal Investigator Email
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Principal Investigator Phone Number
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Principal Investigator eRA Commons ID
Study Coordinators Name
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Study Coordinators email
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Study Coordinators Phone Number
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This request is for:
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A proposal you are writing A funded study Unsure
We have:
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A Final budget A Draft Budget No budget, yet
For your reference, you can view our fee schedule here
What type of research is your project (select all that apply)?
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Clinical Trial Phase
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0 1 1 - 2 2 2 - 3 3 3 - 4 4
If other, please describe type of research
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Funding type
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Please list funding source
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Study Information
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Include: Type of research, funding & IRB status.
We have:
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A Final protocol A Draft protocol No protocol, yet
We would like to talk more about your needs. Please select best contact option.
Email Phone
What is an appropriate day/time to contact you?
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Protocol Title (full text)
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Protocol (short) Title
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Please use short title as included in IRB submission
Brief Protocol Summary
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Study Hypotheses
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Study Specific Aims
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HIV/AIDS Related Protocol
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Yes
No
Pediatrics Protocol
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Yes
No
Is there an IND/IDE associated with the Protocol?
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Yes
No
IND/IDE Number
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IND/IDE Drug Name
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Number of outpatient subjects
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Number of inpatient subjects
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Total Number of Subjects
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Number of Outpatient Visits Per Subject
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Number of Inpatient Visits Per Subject
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Number of Inpatient Days Per Visit
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Projected Start Date
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Today M-D-Y
Anticipated Duration of Study
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In Months
Have you started your initial submission to the IRB?
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Yes
No
IRB of Record
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Emory University Georgia Institute of Technology Morehouse School of Medicine Children's Healthcare of Atlanta Atlanta VAMC Western IRB University of Georgia Other
Please describe, if other was chosen
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What is your assigned study number?
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Have you received IRB approval?
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Yes
No
Approval Date
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Today M-D-Y
Do you need assistance with IRB submission?
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Yes
No
We would like to talk more about your needs. Please select best contact option.
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Phone Email
What is an appropriate day/time to contact you?
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Have you submitted to RAS?
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Yes
No
Who is your contact for RAS?
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RAS Contact Email
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Please provide study speedtype for billing purposes
Do you need assistance with submission to OCR and/or RAS?
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Yes
No
Briefly describe your proposed idea:
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Contract/Award start and end date known?
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Yes
No
Contract Award Start Date
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Today M-D-Y
Contract Award End Date
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Today M-D-Y
Do you know what GCRC Services you might need?
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Yes
No
What GCRC location(s) will you be utilizing to conduct your Study?
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If other, please list location
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Please see related fee schedule for federal studies
Note: Please save for your records
Please see related fee schedule for industry studies Note: Please save for your records
GCRC Services Needed
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Nursing Services (Sample collection, Vital Signs, Assessment and Evaluation, etc.)
Core Lab Services (Lab Processing, Point of Care Testing, Storage, EUHM 24-Hour Lab, etc.)
Bionutritional Services (Meal prep, Food record analysis, iDXA)
Space Only
CR-Assist Only (ECC Only)
Coordinator Services
Recruitment Center Services
Subsidy Voucher (For Federally Funded Studies Only) (NOT AVAILABLE CURRENTLY)
Other
Nursing Services (Sample collection, Vital Signs, Assessment and Evaluation, etc.)
Core Lab Services (Lab Processing, Point of Care Testing, Storage, EUHM 24-Hour Lab, etc.)
Bionutritional Services (Meal prep, Food record analysis, iDXA)
Space Only
CR-Assist Only (ECC Only)
Coordinator Services
Recruitment Center Services
Subsidy Voucher (For Federally Funded Studies Only) (NOT AVAILABLE CURRENTLY)
Other
What specific nursing services are needed?
* must provide value
Please select if outpatient or inpatient study
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By utilizing GCRC Nursing services, you will need to complete Day-to-Day (D2D) orders for each study visit. Please refer to the D2D orders template to fulfill this requirement prior to scheduling your Roundtable.
Note: Please mimic D2D orders off of eCRF guidelines or data entry forms.
By utilizing GCRC Nursing services, you will need to complete Day-to-Day (D2D) orders for each study visit. Please refer to the D2D orders template to fulfill this requirement prior to scheduling your Roundtable.
Note: Please mimic D2D orders off of eCRF guidelines or data entry forms.
Please provide additional details for nursing needs
* must provide value
For your records please see below the Laboratory Sample Retrieval Form
Note: Please save this document for your records
For your records please see below the Laboratory Sample Intake FormNote: Please save this document for your records
Who will be processing labs?
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GCRC Laboratory Staff
Study Team Staff Member
Both
GCRC Laboratory Staff
Study Team Staff Member
Both
Will you need bench space to process samples?
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Yes
No
How often will you need to utilize the space to process samples (how much space, how often, and how many hours?)
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Do you have any specific storage needs?
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Yes
No
Please select storage needs
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Please describe storage needs
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Will a kit be provided by the sponsor?
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Yes
No
OpenSpecimen needed for storage tacking purposes?
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Yes
No
Additional Laboratory Details
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Please select bionutrition needs
* must provide value
Research meal, meal challenge, and whole diet design and preparation
Dietary and nutrient intake assessment using diet recalls and food records
Analysis of nutrient and dietary substrate intake using NDS-R software
Participant education and counseling on research meals and diets
Body composition using anthropometrics, dual energy X-ray absorptiometry (DXA), air-displacement plethysmography (BodPod), multi-frequency bioelectrical impedance analysis (BIA)
Indirect calorimetry for energy expenditure and substrate oxidation
Exercise testing (treadmill and bike) for SubMax and Vmax testing
Bionutrition study design consultation for grant application
Other
Research meal, meal challenge, and whole diet design and preparation
Dietary and nutrient intake assessment using diet recalls and food records
Analysis of nutrient and dietary substrate intake using NDS-R software
Participant education and counseling on research meals and diets
Body composition using anthropometrics, dual energy X-ray absorptiometry (DXA), air-displacement plethysmography (BodPod), multi-frequency bioelectrical impedance analysis (BIA)
Indirect calorimetry for energy expenditure and substrate oxidation
Exercise testing (treadmill and bike) for SubMax and Vmax testing
Bionutrition study design consultation for grant application
Other
If DXA selected, please specify areas of scan
Please describe in detail bionutrition needs
* must provide value
Is additional training and access required for Bionutrition staff?
Yes
No
Please describe space needs
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A charge will apply if other services are requested.
What specific coordinator services are needed?
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Please provide additional details for coordinator needs
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Estimated hours per Subject/Visit
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In hours
Additional hours of required training, study setup, regulatory, etc.
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In hours
Please list total estimated hours coordinator will be needed for study
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In hours
Please see attached recruitment center flyer for information on services that are offered and contact information
We would like to talk more about your needs. Please select best contact option.
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Phone Email
What is an appropriate day/time to contact you?
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Please provide additional details
To better assist you, please select what documents you have that you would like to upload. Please note that draft versions are acceptable.
In order for applications to be routed for review you must submit at the very least the following: Protocol, PI Biosketch, Informed Consent & D2D Orders
Informed Consent Document
Lab Processing Manual Document
PI(s) NIH Bio-Sketch Document
IRB Approval Letter Document
If multiple D2D orders please upload as ZIP file
Clinical Research Key Points*
*Clinical Research Key Points were also uploaded into the study's eIRB application
Person Completing This Form
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Contact Email
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Date Form Completed
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Today M-D-Y
By signing this application electronically, I confirm my agreement with the following acknowledgement
