Dr. El-Rayes, chief clinical research scientist responsible for coordinating and providing high-level direction to the clinical cancer research programs

Study Start Up Required Approvals


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

Atlanta Clinical and Translational Science Institute (ACTSI) 

The Clinical Interaction Network Scientific Advisory Committees (SAC) are responsible for completing scientific and resource review of all protocols requesting resource support from the Clinical Interaction Network (CIN). The SAC meets monthly and protocols must be submitted three weeks in advance of any SAC meeting. Meeting dates and protocol submission instructions can be found on the ACTSI website. 

At the time of the SAC submission, protocols will also be submitted for review by the Safety Advisory Subcommittee (SAS) of the ACTSI. The CIN staff will submit to the SAS on behalf of the Investigator. The SAS will provide their review/comments to the SAC prior to final approval.

Visit the ACTSI 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 subjects;
  2. Experiments utilizing live, recombinant, or attenuated microorganisms for the purposes of vaccination of one or more human subjects; 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. 

Visit the Biosafety Website

Clinical and Translational Research Committee (CTRC)

For cancer clinical trials, in any department, the investigator must apply to the CTRC (complete the CTRC form) prior to seeking IRB approval. 

The Investigator may submit the application in eIRB while awaiting CTRC approval.  Once the CTRC has given approval, a CTRC administrator will move the study in eIRB to the IRB Inbox (i.e., the study won’t electronically go to the IRB until the CTRC administrator moves the study after CTRC approval).

CTRC Form

Conflict of Interest (COI)

The investigator and anyone named by the PI who is independently responsible for the design, conduct, or reporting of research must complete eCOI for the study. 

Visit the COI Website

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 notifies them that the checklist has been completed.  The Office of Quality Checklists are located on the IRB website.

Completed checklists should be sent to Laura Deane in the Office of Quality at ldeane@emory.edu.

For drug and device studies, Emory Healthcare also requires study teams to complete a Key Points Summary that will be placed in the subjects’ Emory electronic medical record so that EHC providers taking care of patient subjects 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. The Summary can be located on the IRB website.

For studies involving sensitive and stigmatizing information, inclusion of study information into the medical record may discourage subjects from participating.  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. The Summary can be located on the IRB website. 

Visit the IRB Website

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 GROC application form can be found on the IRB website.

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 subjects.

ROC Application 

Institutional Review Board (IRB)

IRB approval is required before the research can start.  The investigator must submit to the Emory or Western 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 to go to WIRB and instructions for applying to WIRB can be found on the Emory IRB website. 

Visit the WIRB Webpage

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.  For studies requiring OCR review (below), OCR 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.

For studies that do not require OCR review, the PI must contact Susan Rogers at IDS at 404-712-7485 or sroger2@emory.edu and submit to her the written protocol, Investigational brochure (IB), budget request and IRB number, if available upon initial contact to 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 the OCR website.

Visit the OCR Website

Office of Research Compliance (ORC)

ORC offers counseling to all Emory investigators acting both as Sponsor and Investigator (i.e., “Sponsor-Investigators”), as defined by the FDA.  However, ORC review is mandatory for all Winship Cancer Institute Sponsor-Investigator studies prior to enrolling subjects.  ORC advises contacting the office early in the approval process.  Contact Margaret Huber (404-727-2233 or mhuber@emory.edu) or visit the ORC website for more information.

Visit the ORC Website

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 course of the study, the PI will work with the Office of Grants and Contracts for the fiscal activity of the trial.

Visit the Emory Proposal Express

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 for Procedures with Human Subjects form.   If the research involves nuclear medicine procedures, the investigator must submit the Human Studies Application for Radionuclide Use form.  Both forms are located on the radiation safety page of the Environmental Health and Safety Office website.

Visit the Environmental Health and Safety Office Website

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 subjects.

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.

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