Modification

Creating a Modification in eIRB

To submit a Modification in eIRB: 

  1. Go to https://eirbemory.huronresearchsuite.com/http://eresearch.emory.edu/emoryand log in using your netID and password
  2. Under the "IRB" tab at top, click on the "Active” sub-tab. Find the study you wish to modify using the Filter, or sort. 
  3. Once you have clicked on the link to the right study, click "Create Modification/CR" 

The Mod/CR smartform for your study will open: 

  1. Answer all required questions and respond to prompts 
  2. Under “Modification scope” indicate whether you are updating "study team member information" or "other parts of the study," or both (note: you will not be able to make study team changes - other than PI change - unless you select "Study team member information" as the type of change)
  3. If subjects need to be notified of the changes, indicate whether it will include current and/or former participants.
    • The IRB generally expects participants to be informed when there are updates that may impact risk or willingness to participate.  

Important Tips

  • Summarize your modifications clearly. Our reviewers require detail to be efficient, so please elaborate on changes made. You can include tracked versions or even a “summary of changes” document but we will still expect to see a description of the updates in this section. We are most concerned with changes that significantly impact risk or study design.  
  • Updating Microsoft Word documents (protocol, consents, etc): Tracked-changes copies are not necessary 
    • Use the "Update" function to submit revisions to documents.
    • Upload a CLEAN copy only of the revised document. Do not "Add" a new entry. 
    • The system can then automatically create a "compare" or "track-changes" version for the IRB.
    • You may wish to keep a track-changes copy in your own records, though.

Modification to add or remove study team members

Study team changes can be done as a stand-alone modification, as a combined modification for "Other parts of the study" as well, and/or as part of a Modification/Continuing Review (Mod/CR) combination. You indicate your choice on the first page of the Mod or Mod/CR form.

You may submit one "Study team member information" Modification simultaneously with one "Other parts of the study" modification or with one Mod/CR.

If you chose to add or remove study team members as part of a Mod/CR, it will delay the approval of the study team changes. If urgent, it would be better to submit a separate modification for the study team changes.  

PI Changes: you will need to select "Other parts of the study" to have access to the first page of the submission where this information resides.  If you are changing the PI and other team members, select both options ("Study team member information" and "Other parts of the study").

Remember to also update the protocol, and the cosnent form(s) if applicable.

  • If the PI is leaving/coming from another institution, fill out this form only when 1) taking or bringing IRB approved studies to/from the other institution, or 2) will remain engaged in research (with the other institution) to be able to continue the study at Emory/Other Institution or 3) if they are taking/bringing the study grant with them.  Attach this form with your submission. Your analyst will let you know if you require an institutional agreement in these cases.
Adding an external collaborator: 

These are individuals that are working at Emory or non-Emory sites under the oversight of Emory researchers, who are not directly affiliated with Emory, and who do not have their own IRB review. These individuals should only be added if they are involved in the "design, conduct or reporting of the research." 

Do not add anyone who will neither interact/intervene with research subjects nor work with HIPAA-identifiable private information.

  1. Click on "Add" and a new window will open.
  2. Attach a file created using our External Study Team Members template.
  3. Separately, attach CITI training records for the individual(s), and the IRB Authorization (or Independent Investigator) Agreement (IAA/IIA), if applicable.

  • We will need to do an IRB Reliance Agreement (IAA) with the person's home institution, if that institution regularly conducts human research, and we do not already have an agreement in place with them (e.g. CHOA, Grady, VA, Georgia Tech, Morehouse).

  • If the person's home organiation does not regularly conduct human research, or if they are an independent contractor, they may instead sign an Independent Investigator Agreement (IIA).

  • For more information about this process, go to our Collaborative Research and External IRBs page.

Modifications to Funding Sources

Adding a new funding source: you MUST use our Guidance to Connect Grants and IRB Approved Protocols or the Modification will be returned for clarifications.

Delays Submitting Study Documents (Protocol, ICF, IBs, etc)

If you or your sponsor (as applicable) are implementing changes to the study, you are required to update your study documents using a modification (MOD) submission. Delays in submitting some kinds of changes to the IRB late constitutes noncompliance.

  • If the study is closed to enrollment and no longer actively treating subjects, no RNI is needed due to a reporting delay unless they are adding a new risk affecting subjects and that risk affects any subject who has received the study drug or treated with the study device, not only subjects who are currently receiving treatment.
  • If you are submitting documents that include a new or increased risk, such as a new SAE described in the protocol and/or informed consent, new risks in an IB, etc.), the IRB requires these changes to be submitted within 10 business days of the document receipt from the sponsor (*).
    • If you are submitting revised/new documents with a new or increased risk
      • If the document’s version date is older than 10 business days but less than 30 calendar days from IRB submission:
        • State when you received the information from the sponsor (it is required that the submission is made within 10 business days of the document receipt from the sponsor)
        • Our staff will not stop review of the modification but will log a comment asking about the delay in submission.
          • If the reason for the delay was a study team oversight, we will request an RNI. 
          • If the reason for the delay was sponsor oversight, an RNI is not required.
      • If the document’s version date is older than 30 calendar days from IRB submission:
        • State when you received the information from the sponsor (it is required that the submission is made within 10 business days of the document receipt from the sponsor)
        • Our staff will not stop review of the modification but will log a comment asking about the delay in submission.
        • An RNI is required at this time, regardless of the root cause of the delay. Include the root cause of the submission delay in the RNI.  If this was a sponsor oversight please provide the sponsor's CAPA plan to prevent this in the future and documentation showing they are at fault. 
  • Before issuing the MOD approval letter for the new documents, the IRB needs to receive a response about the delay via logged comment and the submission of an RNI if needed.
(*) Note: If you received notification from your Sponsor about a risk or procedure change, but are awaiting revised protocol/ICF’s, submit an RNI within 10 business days to include any communication from the sponsor (Dear Investigator letter, etc.), and to describe your process for verbally notifying participants.  (If no participants will be impacted by the changes, it is acceptable to wait for the revised documents.)