Study Submission Guidance
- NIH Protocol building tool for Phase 2 or 3 IND/IDE Trials: Highly encouraged when submitting NIH grants for these types of studies. A text Protocol Template is also available.
- Retrospective Chart Review
- Secondary Data/Specimen Analysis
- HUD for Treatment Use
- Advertising and Recruitment: Guidance & Information
- Can raffles be used as compensation? Only if you offer to everyone. See here: https://www.ogc.emory.edu/downloads/advisories/RafflesAndOtherContestGiveaways.pdf
- Researcher Guidance for using the Psychology Student Recruitment Pool
- FDA guidance on payment for participation
ResearchMatch.org: A useful tool to match up with people who have signed up to find opportunities to participate in studies
These policies are the basis for the required language you find in our consent form templates.
- When is a LITS security review needed? Guidance to help you determine if you need a LITS security review when using a software or app for research- version 5/7/2018 NEW
- LITS approved apps for research - version 6/7/2017
- Mobile Medical apps worksheet (also in "Drugs, Devices, and Other FDA Regulated Products" section below)
- Email encryption information (from LITS): email encryption is required if emailing sensitive information to people outside Emory or consents (even if empty) to study participants
For studies taking place at CHOA, please fill out the Basic Information Security Risk Assessment worksheet and send the completed worksheet to BISRA@choa.org. Questions about medical apps being used at CHOA can be directed to:
- Annabel Biwott- Annabel.firstname.lastname@example.org (404) 785-7175
Please see the "Clinical Study Initiation" section at left.
- Guidance and FAQs
- e-Maintenance of Clinical trials documents: new guidance to give you a step by step of how to certify your hard-copy documents electronically for storing purposes
- Emory IRB Medical Device Guidance: information about when a mobile app will be considered a mobile medical app
- Dietary Supplements FAQ
- FDA-CDER Chronicles: Drug, Not a drug, or More
- Expanded Access Use - Devices
- Expanded Access Use - Drugs
- Guidance for Emory Sponsor-Investigators
- HUD Patient Information Sheet
- Investigational Drugs and Devices
- Worksheets and Forms
- Mobile Medical apps worksheet: if using a mobile app during a study, you are required to fill this form.
- REMS Checklist: for studies using a drug or biologic under REMS program (ver 6/18/2018)
- Dietary Supplements and/or Medical Foods Worksheet: required to document if using as a drug
- Humanitarian Use Device (HUD) Checklist: useful to remind you of HUD requirements
- Investigator Justification for IDE Exemption
- Investigator Justification for IND Exemption
- Investigator Checklist for the Use of Schedule I Controlled Substances: Please submit completed form to Margaret Huber at email@example.com in the Office of Compliance (OC) for review of any research study using a controlled substance. OC will perform a compliance review to ensure that processes are in place to meet state and federal requirements (ver 6-18-2018).
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 (firstname.lastname@example.org). 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 (email@example.com) for the application.
- Children's Healthcare of Atlanta is an entity distinct from Emory. When doing research that involves CHOA, please see the "Collaborative Research" section at left (CHOA information at bottom of page), and always submit this form to the CHOA IRB even when Emory is the IRB of record: CHOA IAA Acknowledgement Form
- CHOA-IRB Application for Medical Imaging Dose Estimate
- Forms and Contact Information from Grady's Office of Research Administration
- Emory-St. Joseph's Hospital Clinical Research Procedures