New Submission Guidance


General guidance on submitting a new study can be found in the presentation, "10 Steps to IRB Approval."

Initial Submission Guidance and Documents

Clinical Study Tools, Templates and Checklists

  • Please see the "Clinical Study Initiation" section at left.

Departmental Review Help

  • Please look for the correct Departmental Approval department using this list. See FAQ (under Departmental Approval section) for more details. 

Lay Summary Guidelines

Protocol Guidelines

Advertisement, Recruitment, Compensation

Checklists for Department of Defense and ICH-GCP

Costs and In Case of Injury Policies

These policies are the basis for the required language you find in our consent form templates.

Additional Study Documents and Guidance

Data and Safety Monitoring Boards and Plans Guidance

Drugs, Devices, and Other FDA Regulated Products

Ancillary Review

Review by applicable compliance/oversight offices is needed before IRB can issue final approval, or (in the case of Office of Quality) before IRB can issue stamped consent forms. eIRB has integrated approval buttons for each of these offices, but you must submit applications separately to each.

  • Biosafety Review Guidelines. Special Recombinant DNA review is also needed for studies falling under the NIH policy
  • Conflict of Interest Guidance for Emory University. When you disclose COI in our eIRB smartform, the IRB must receive a determination from the COI office prior to final IRB approval. The IRB also reviews all COI management plans, and may rarely add additional requirements to the plans.
  • CTRC: Reviews all cancer-related resarch involving Emory (not solely studies taking place at Winship Cancer Institute; includes chart reviews, public health studies, surveys, etc). CTRC approval usually must be in place before the IRB begins our review; eIRB sets this requirement automatically when "Cancer-Related Research" is checked off under "Biomedical Research" section (for chart reviews or other studies that don't trigger that page of the eIRB smartform, you can check it off via the jump-to mention at the top of each page; or, the IRB staff will catch it once the study comes to us and route it at that point). Please see https://winshipcancer.emory.edu/research/clinical-trials-office/clinical-translational-review-committee.html for information and application form (submit to CTRC directly, outside of eIRB; may be done prior to eIRB submission but you must have created a new study, to generate an eIRB number).
  • Office of Quality Checklist: The Office of Quality oversees completion of multiple sign-off's required before study initiation, e.g. nursing, pharmacy, laboratory, radiology. Some parts of the checklists for sign-off are now built into eIRB; the radiology and laboratory ones can be found here: http://irb.emory.edu/forms/clinical.html. Office of Quality final sign-off must be in place before the IRB releases stamped consent forms, but does not hold up IRB approval.
  • Radiation Safety: Complete Radiation Summary Form, and the Human Studies Application for Radiation Use, and print, sign, and submit by fax (404-727-9778) or scanned email to Ike Hall (mjhall@emory.edu). Also upload Radiation Summary Form into eIRB submission, under "Miscellaneous Documents." The Radiation Summary Form determines what consent form language to use for describing the risks of the radiation in your study. Call the office with questions:  http://www.ehso.emory.edu/about/contact.html 
  • RDRC: A radiation subcommittee that reviews basic research using radioactive drugs in humans without an IND (must be 30 or fewer subjects). Contact Ike Hall (mjhall@emory.edu) for the application.

HIPAA-Related Guidance

Vulnerable Populations Worksheets

Children's Healthcare of Atlanta

Grady and St. Joseph's Hospital Studies

ResearchMatch - A useful tool for recruiting subjects