Study Start Up Required Approvals

The list below represents a brief description of approvals at Emory and does not describe, in detail, the functions of every department.  For further information, follow links to departmental websites.

Georgia Clinical and Translational Science Alliance (GCTSA):  Any research investigator with an appointment at Emory, Morehouse, Georgia Tech, or University of Georgia is eligible for GTCSA support.  The Georgia CTSA Clinical Research Centers (GCRCs) is a service center focused on supporting and streamlining new clinical trials. The GCRC offers inpatient and outpatient research units, specialized staff, space, equipment, coordinator support, help with study initiation, budgets and more. For more information and GCTSA application visit GCRC website.

Biosafety:  The investigator is required to submit a Notice of Intent (NOI) to the Biosafety office when the proposed research involves any of the following:

1. Experiments involving the deliberate transfer of recombinant DNA or RNA, or DNA or RNA derived from recombinant DNA into one or more human participant;
2. Experiments utilizing live, recombinant, or attenuated microorganisms for the purposes of vaccination of one or more human participants; or
3. Experiments involving use of investigational vaccine containing recombinant DNA in humans.

For more information on the Biosafety requirements or to download forms, visit the Biosafety website

Protocol Review and Monitoring Committee (PRMC).  For cancer clinical trials, in any department, the investigator must apply to the PRMC prior to seeking IRB approval. Complete the PRMC form. The PRMC is available on Winship intranet (sharepoint) and is done electronically. The Investigator may submit the application in eIRB while awaiting PRMC approval. Once the PRMC has given approval, a PRMC administrator will move the study in eIRB to the IRB Inbox (i.e., the study won’t electronically go to the IRB until the PRMC administrator moves the study after PRMC approval).

Conflict of Interest (COI):  The investigator and anyone named by the PI who is responsible for the design, conduct, or reporting of research must complete eDisclose for the study. Visit the RCRA website for more information and the link to the eDisclose system

Emory Healthcare Office of Quality:  For studies being conducted at an Emory Healthcare (EHC) facility, or that have a procedure or test done in an EHC facility, study teams must complete the applicable Office of Quality Checklists and submit to the Office of Quality. The IRB will not distribute the stamped informed consent and HIPAA authorization forms until the Office of Quality has given final sign-off. The Office of Quality Checklists are located on the IRB website

For drug and device studies, Emory Healthcare also requires study teams to complete a Key Points Summary that will be placed in the participants’ Emory electronic medical record Epic so that EHC providers taking care of patient participants can have information on the study drug/device, eligibility criteria, and emergency contact information for the researcher.  

The Key Points Summary must be uploaded with the initial eIRB application in the Data and Safety Monitoring Plan section. For studies involving sensitive and stigmatizing information, inclusion of study information into the medical record may discourage research participation. For such studies, the research team can request a sensitive determination by the IRB by completing the Request for Sensitive Study Status Worksheet and Sensitive Studies Summary in place of the Key Points Summary. 

The Request for Sensitive Study Status Worksheet and Sensitive Studies Summary must be uploaded with the initial eIRB application in the Data and Safety Monitoring Plan section.

Grady Office of Grant Administration:  All studies using Grady as a site must obtain financial clearance through OGA. This approval can be obtained while the IRB approval is pending. Contact Amaka Wright in Grady OGA at (404) 616-1828 or awright3@gmh.edu

Grady Research Oversight Committee (GROC): All studies using Grady as a site must seek GROC approval after IRB approval.The investigator must complete the GROC application and submit it to GROC, along with the IRB approval letter, stamped informed consent and HIPAA authorization forms, and the lay summary.  Further instructions are located on the GROC application. Grady researchers must obtain both IRB and GROC approval before starting research with human participants.

Institutional Review Board (IRB): IRB approval is required before the research can start. The investigator must submit to the Emory or external IRB, the following documents when applicable to the study: initial application, the investigator’s brochure, protocol, informed consent form, HIPAA authorization form, questionnaires, study advertisements, and relevant FDA correspondence. 

Instructions on obtaining an eIRB account can be found on the IRB website. Studies that are eligible for external IRB review and instructions can be found on the Emory IRB website

Investigational Drug Service (IDS):  Investigational drugs and FDA-approved drugs that are provided by the sponsor or paid for by the grant are required to be stored in the Emory IDS, for research conducted at Emory facilities. The Office for Clinical Research will initiate discussion with IDS regarding charges for drug storage and dispensation; these charges will be included in the budget for the trial. The PI must provide the sponsor with the address of the IDS.

Office for Clinical Research (OCR):  OCR review is required for studies with billable items and services.  Complete an OCR routing package by emailing the following documents to the OCR listserv at OCR@emory.edu: Request for Prospective Reimbursement Analysis and Budget Development Form, protocol, clinical trial agreement/contract, Investigator Effort Calculations Report, draft budget, informed consent drafts, and recent FDA correspondence.

For more information on the OCR application requirements, visit their website

Research integrity and Compliance (ORIC):  ORIC offers assistance to all Emory investigators acting both as Sponsor and Investigator (i.e., “Sponsor-Investigators”), as defined by the FDA. ORIC advises contacting the office early in the approval process. Contact Margaret Huber (404-727-2233 or mhuber@emory.edu) in the ORIC for more information.

Office of Sponsored Programs (OSP):  OSP assists researchers with funding applications, proposal development, budget preparation, proposal processing with the sponsor, funding negotiation, and awards acceptance.  To get started, route the proposal and budget through Emory Proposal Express (EPEX). 

After Emory has received the award, the Data Management Group will send the PI the electronic notice of award (eNOA) and SmartKey.  During the study, the PI will work with the Office of Grants and Contracts for the fiscal activity of the trial.

Office of Technology Transfer (OTT): OTT assists researchers with material transfer agreements (MTA), intellectual property rights, and negotiate license arrangements for intellectual properties.

Radiation Safety:  Emory University Radiation Safety Committee (RSC) approval is required for studies that involve imaging procedures that utilize ionizing radiation, such as x-rays, CT scans or Nuclear Medicine Imaging scans. Procedures such as Echocardiogram or MRI do not involve ionizing radiation and thus do not require Radiation Safety Committee review.

The investigator must submit to the RSC the Radiation Summary and the Human Studies Application for Radiation Use forms.  Both forms are located on the Radiation Safety webpage of the Environmental Health and Safety Office.

VA Research and Development Committee (R&D):  All studies using the Atlanta VA Medical Center as a site must seek VA R&D approval after IRB approval has been obtained.  VA researchers must obtain both IRB and R&D approval before starting research with human participants.

To complete the R&D Application, the investigator must have an account with the Atlanta Research and Education Foundation (AREF). To create a new account, log into the AREF website. With an AREF account, you can log in to the electronic Request to Review Research Proposal (eRRRP) from a VA computer using your AREF Online credentials at https://www.va.gov/atlanta-health-care/research/research-credentialing-and-training/

Researchers must submit to the R&D the protocol, IRB approval, and other pertinent documents specific to the research project.