Study Submission Guidance


Before submitting in eIRB, review our eIRB smartform helpful tips. 

View eIRB Smartform Help

Additionally, here are helpful submission tools and templates.


Lay summaries are actually very important for efficient IRB review, throughout the life of the study. Please use the guidelines below. Studies may be returned if lay summary is inadequate.

Access our current templates for Informed Consent Forms, HIPAA authorizations, and Assents.

For informed consent guidance, including the use of electronic Informed Consent, visit Consent Instructions and Guidance.

Ancillary reviewers (including department reviewers): watch this video to know how to submit your reviews

For instructions on which ancillary reviews are required (e.g. biosafety, radiation safety, department review, etc...), please see the section "Overview: Submitting a Study in eIRB" on our New Study Application panel on page-level help.

Please see the "Clinical Study Initiation" section.

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.

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

For studies taking place at Children's Healthcare, please log in to their intranet (Careforce) and access this CareforceConnection document for information on how to submit for security review. Please refer all questions to BISRA@choa.org.

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.

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-Assessment Tool

High-complexity clinical trials with international sites
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.

Related Guidance

Guidance and FAQs

Worksheets and Forms

For information about research with students and the Family Educational Rights and Privacy Act (FERPA), please access the Emory IRB Family Educational Rights and Privacy Act (FERPA) Guidance and Worksheet (DOCX).

Access additional links to other Emory Offices' FERPA policies at FERPA

General modification submission instructions are found here: Modification page-level help

If you or a colleague have a new grant, please use this guidance before trying to add it to an ongoing IRB-approved study:

Please also note that Supplements and Competing Renewals need to be submitted to the IRB as well, along with corresponding updates to the protocol and/or consent form as needed. Supplements may or may not need to be submitted as new IRB protocols instead. Please see the guidance above for connecting new grants to existing protocols. Thank you!