Study Submission Guidance
Technical instructions for using the eIRB system are found here: eIRB Training
Below are templates, tools, and guidance documents for your IRB submission. Click any header to expand the section.
Which Protocol Template and Protocol checklist should I use?
Use our Biomedical template and Biomedical Protocol Checklist if your study involves clinical procedures or tests (except for behavioral studies where the only collected sample is obtained via a non-invasive method, for example, saliva for cortisol tests). Last Version 3/15/2021
Use our Supplement to Sponsor Protocol and Checklist for studies that are industry-sponsored and industry-initiated, or when we are one of the sites in a multisite study we are not leading. You will be required to attach these forms plus the main consent from the sponsor to the submission. Last Version 3/12/2021
Use our Chart Review template and Chart Review Checklist for studies involving solely a review of medical charts. If your study involves solely the review of charts at CHOA, submit to the CHOA IRB instead. Last Version 3/12/2021
Use our Registry, Repository, or Database and Checklist for projects creating a registry, biospecimen repositories, or databases created, even if partially, to conduct research projects in the future. If this registry, repository, or database will only include data or biospecimens from CHOA participants, submit to the CHOA IRB instead. Last Version 3/12/2021HUD for Treatment Use template.
Winship Cancer Institute
- NIH Protocol building tool for Phase 2 or 3 IND/IDE Trials: Highly encouraged to refer to this when submitting NIH grants for these types of studies. Ensure that you are covering all these elements when creating your protocol using our templates. If NIH requires you to use their template, you will be required to create a supplement to Sponsor Protocol with your protocol.
Community engagement is vital to ensure the recruitment of all populations, especially those that are marginalized or who do not participate in research for lack of trust.
Emory has a great partner in the Georgia CTSA, who provide guidance and resources to ensure that participation in research is more equitable.
- Can raffles be used as compensation? Only if you offer to everyone. See here: https://www.ogc.emory.edu/downloads/advisories/RafflesAndOtherContestGiveaways.pdf
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.
Every study requires a plan with some level of data and safety monitoring. Monitoring, an ongoing process of overseeing the progress of a study from start to finish, is a quality control tool for determining whether study activities are being carried out as planned and whether there are any unexpected safety concerns. Monitoring enables study teams to identify and correct any deficiencies in the conduct, record keeping, or reporting. The Data and Safety Monitoring Plan (DSMP) should be based on a risk assessment of critical data and processes that are necessary for human participant protection and integrity of the investigation.
A study that involves no more than minimal risk will require a plan to protect data and ensure the safety and confidentiality of research participants. A study that involves more than minimal risk (reviewed at the full board) will have additional requirements depending on the level of complexity. The IRB will consider the level of risk and burden a participant may experience in a study when determining additional requirements for a plan.
After reviewing the complexity of a study, the IRB will require the following for medium and high-complexity studies:
- Data Safety Monitoring Plan (DSMP): Must include a plan for both (1) review of participant safety, welfare; and data integrity; and (2) site monitoring conducted by a person independent from the study, ensuring data accuracy and protocol compliance.
- (1) Review of participant’s data for safety, welfare, and to ensure data integrity: Study teams should have a process to review data during initial data collection.
- (2) Site Monitoring: study teams should a process to ensure that the study is following the protocol, including a review of study procedures, study intervention, and data collection processes.
- For high-complexity studies, monitoring should be conducted by a designated study monitor, an experienced, knowledgeable person who is, ideally, independent of the study team. The responsibility for site monitoring may be delegated by the study sponsor to a Contract Research Organization (CRO).
- Site Monitoring conducted via Self-monitoring: a process for self-assessment of protocol compliance and data integrity which can be part of an overall DSMP. For medium-complexity studies, the IRB may approve a monitoring plan relying on self-monitoring. Click here for a Self-Monitoring Tool
Besides all the above, as applicable, these studies are required to engage a CRO working in the study country, and/or to consult with legal counsel regarding compliance with the country’s clinical research regulations.
Check this guidance for more information.
- 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
- LITS approved apps for research: Find a complete and updated list on the LITS website
- Emory Zoom Account Type: HIPAA-compliant vs. General (also on the LITS website)
- 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
- Use of Electronic Informed Consent. Revised on 5/31/2020
For studies taking place at Grady: email the device and data use information to the Grady privacy officer, D’Andrea Morning, at djmorning@GMH.EDU for her review and approval. Upload the email in the study history for our records.
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
- 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 4/30/2019)
- 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
- Emory IRB Device Checklist: required for documenting IDE exemption, non-significant and significant risk device under an abbreviated IDE or an IDE, respectively. (ver 5-13-2020)
- Investigator Justification for IND Exemption
- Investigator Checklist for the Use of Schedule I Controlled Substances: Please submit a filled form to Margaret Huber at firstname.lastname@example.org in the Office of Compliance (OC) for review of any research study using a controlled substance. The OC will perform a compliance review to ensure that processes are in place to meet state and federal requirements (ver 6-18-2018).
Ancillary reviewers (including department reviewers): see this video to know how to submit your reviews
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. For more information about human gene transfer studies review this Emory Biosafety Review Guidelines or email EHSO at email@example.com for studies using any of the following: microorganisms or infectious materials; human cells, cell lines, serum, stool samples, or any other human source materials; nanomaterials; genetically modified primary cells or cell lines; genetically modified live or live-attenuated microbes; human or non-human primate blood that is brought to a laboratory for further experimentation and transferred to a central lab; arthropods; plant products; toxins; environmental samples.
- 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 electronic CTRC submission 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). Note: the e-CTRC form only works when logged into the Emory network.
- 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
Access additional links to other Emory Offices' FERPA policies at http://registrar.emory.edu/records-transcripts/ferpa.html