Today M-D-Y This is the date the request was submitted
Now M-D-Y H:M This is the date the request was submitted
Operational and Quality Control Projects must have a Director and above approval before moving projects into production. Project assistance services are limited for Operational REDCap projects.
REDCap ID (if applicable) This is the ID you use to log into REDCap . If you've never logged in, please use your employee ID.
First Name
* must provide value
Last Name
* must provide value
Email Address
* must provide value
Is this project for administrative purposes only
Yes No
(Used for auditing) This project entry is related to a project developed for internal REDCap use, ETL etc... and does not require the full intake approval process.
Project Type
* must provide value
Research
Operational Support
Research
Operational Support
Operational and Quality Control Projects must have a Director and above approval before moving projects into production. Project assistance services are limited for Operational REDCap projects.
RESEARCH DEFINITION According to 45 CFR 46 , a human subject is "a living individual about whom an investigator (whether professional or student) conducting research:
Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens." IF YOUR PROJECT DOES NOT MEET THESE REQUIREMENTS, PLEASE SELECT 'OPERATIONAL'
Are you a director or above?
* must provide value
Yes No
Director or Above Information
Name of Director or Above
* must provide value
Director or Above Email Address
* must provide value
Principal Investigator/Project Lead Information
First Name
* must provide value
Last Name
* must provide value
Email Address
* must provide value
PI/Project Lead CHOA Network ID
This is the ID he/she uses to logon to your computer.
Affiliation or Institution
Is this research study funded?
* must provide value
Yes
Yes, Pending
No
Don't Know
Yes
Yes, Pending
No
Don't Know
Is this a clinical trial?
* must provide value
Yes No
Does this project need to meet FDA CFR 21 Part 11 Compliance?
* must provide value
Yes No
PLEASE NOTE: All FDA 21 CFR Part 11 project study teams must complete training for Part 11 compliance. The REDCap Admin will schedule training during the consultation.
The project cannot be moved to production until training is complete.
Funding Type
* must provide value
Children's Foundation Donor Funds
Non-Profits & Foundations
Private Industry
State/Local Gov't
U.S. Federal Gov't
Other
Children's Foundation Donor Funds
Non-Profits & Foundations
Private Industry
State/Local Gov't
U.S. Federal Gov't
Other
Funding Source
* must provide value
Will this be an incoming subaward?
* must provide value
Yes No
Fee Structure for Funded ResearchPlease note: Clinical trials are subject to FDA 21 CFR Part 11 and require additional development, training, and maintenance hours. As a result, the initiation fee has increased.
Fee Structure for Funded Research
Full Project Name
* must provide value
Short Project Name
(less than 50 characters)
* must provide value
Limit project name to 50 characters.
Description of the project
* must provide value
Please provide a detailed description, as it will help with the approval process
Is this a copy of a previous project?
* must provide value
Yes No
Please provide the URL of the previous project.
* must provide value
The option " " can only be selected by itself. Selecting this option will clear your previous selections for this checkbox field. Are you sure?
Which of the following would you like to include in the new version of the project if they are available?
Select all that apply.
* must provide value
Project Area
* must provide value
Asthma Audiology Autism Behavioral/Mental Health Cancer Cardiology CPR Cystic Fibrosis (CF) Dermatology Diabetes Digestive Diseases Emergency Department/Medicine Employee Health Facilities Family Services Finance General Surgery General Training Genetic Disorders HEM/ONC HIS Human Resources Infectious Disease IS&T Neurological Disease Nursing (Not Associated w/Condition) Nutrition (Patient-Related) Orthopedics Parking/Transportation Pathology/Laboratory Psychiatry/Psychology Pulmonary Quality Radiology Registry Rehab Sickle Cell Strong4Life Transplant Tuberculosis Wellness (Includes Physician Wellness, ERGs, but NOT S4L) Work/Life Other
Select the Division(s) most appropriate for your project (i.e., where participants will be recruited from if research):
* must provide value
Other Project Area
* must provide value
What specialty is the AFLAC study under?
* must provide value
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
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
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
Campus Location
* must provide value
Alpharetta Atlanta Plastic Surgery CAP Chamblee Cherokee Urgent Care CPG Data Center Distribution Warehouse Duluth (sports) Egleston Emory Children's Center Fayette Forsyth Hamilton Mill Hudson Bridge Hughes Spalding Ivy Walk Marcus Autism Center Meridian Mark MOB N. Druid Hills North Point Satellite Blvd. Scottish Rite Support Buildings Suwanee Town Center Webb Bridge Other
Specify Other Campus
* must provide value
Will you need assistance building your project?
* must provide value
Yes No
Will you populate this project with data you requested, or will request, from the Data Delivery Unit?
* must provide value
Yes
No
Don't know
Does your project contain PHI?
* must provide value
Yes No
Will this project involve Patient facing pre-arrival forms /surveys?
* must provide value
Yes No
HIPAA
The Health Insurance Portability Accountability Act (HIPAA) Privacy Rule provides federal protections for individually identifiable health information held by Children's as the covered entity and our business associates. HIPAA gives our patients an array of rights with respect to that information. At the same time, the Privacy Rule is balanced so that it permits the disclosure of health information needed for patient care and other important purposes. The HIPAA Security Rule specifies a series of administrative, physical, and technical safeguards for covered entities and their business associates to use to assure the confidentiality, integrity, and availability of electronic protected health information. Click here to learn more Has an IRB reviewed your study and provided approval, waiver or a non-human subject determination (NHSD) submission?
* must provide value
Yes
No
Not Sure
Which IRB reviewed your study submission?
* must provide value
CHOA
Emory
I Don't Know
Children's Healthcare of Atlanta does not require review of studies that do not meet the definition of human subject research. Often there is a "grey area" between Quality/Process Improvement, Case Studies, EBP and Research. This Guidance is to help you define your project at the onset and to ensure proper review and regulatory requirements are met.
Your project may require a non-human subject determination (NHSD): Nonhuman subjects research (NHSR). Typically, IRB staff make NHSR determinations, which don't require review by a member or board review. Timeline: Three to five days.
If you're unsure if you're conducting human subjects research or you're certain you're not conducting human subjects research but your sponsor or a publication requires certification, please complete the nonhuman subjects determination form and submit to the IRB for an official determination and letter. Err on the side of caution and consult the IRB if you're uncertain whether the study is human subjects research.
Have you received any of the IRB information (IRB #, IRB approval letter, NHSD form, or an IRB waiver document for this study?
* must provide value
Yes, (IRB document (i.e. NHSD form, approval letter, IRB waiver) received as of ______ -please upload IRB document below)
No (I do not have an IRB number as of ______ )
No (I have an assigned IRB number (enter below) but have not received IRB review documentation/approval as of ______ )
Yes, (IRB document (i.e. NHSD form, approval letter, IRB waiver) received as of ______ -please upload IRB document below)
No (I do not have an IRB number as of ______ )
No (I have an assigned IRB number (enter below) but have not received IRB review documentation/approval as of ______ )
You have indicated that you do not yet have an IRB submission. This may cause a delay in the creation of your project. REDCap cannot process your request without a pending IRB application. Please provide us the IRB number as soon as the IRB application has been initiated to ensure project creation. Thanks!
Will your data collection possibly be used in any of the following ways? Publication - results published
Cited in another paper
Presented on a poster display
Graduate or senior study essay or thesis * must provide value
Yes No
If yes to any of the items, your project may need IRB review or approval.
Your project requires IRB review if it meets the DHHS definition of "Research" (a systematic investigation designed to contribute to generalizable knowledge and involves one or more research participants OR meets the FDA definition of Research (involves a test article (drug, device, biologic) and at least one research participant). IRB Number (Please enter with "IRB000" or "STUDY0000" in front of the number)
* must provide value
How are you going to be consenting patients?
* must provide value
Paper Consent
Digital Consent
Verbal Consent
No Consent Needed
Paper Consent
Digital Consent
Verbal Consent
No Consent Needed
Upload IRB letter, NHSD Form or Waiver here
You can also email the IRB letter or waiver to: Redcap Inbox Is this a multi-site or single-site?
* must provide value
Single - CHOA department only
Multi-site
Not Sure
Single - CHOA department only
Multi-site
Not Sure
How many sites are involved in your project?
* must provide value
Will there be people on this project who are Non-CHOA employees?
* must provide value
Yes No
NOTE: External (non-CHOA) users include Emory faculty/email addresses (e.g. john.doe@emory.edu)