eIRB Page Level Help

Users with an Emory or Emory Healthcare NetID can log into eIRB using their NetID and password.

Old eIRB: Once you log in, your account will be created automatically.

New eIRB:

• If you have never used eIRB (old or new system) or eIACUC before, you may need to log into eIACUC once (eIRB and eIACUC share a user database). Once logged in, you can go back to eIRB.

• If you did have an account in the old eIRB, you should be able to log into the new eIRB seamlessly.

Please note that eIRB will only send notifications to the email address listed on your account properties page.

New University Employees/students without an Emory Account:

After you attend employee orientation you can obtain an Emory NetID.   Once you have an Emory NetID, follow the above steps for those who have an EU/EHC account to log into eIRB.

If you are in the process of being hired as an Emory University employee and do not yet have your NetID, DO NOT request a sponsored account. Please contact your HR department and have them start the process of creating your Emory University or Emory Healthcare credentials. Once those have been established, please follow the instructions for those who have an EU/EHC account to log into eIRB. More information about Sponsored Accounts and who is eligible can be found at Emory Service Now.

To create a new study in eIRB:

• Go to SaaS eIRB and log in using your Emory NetID and password.
• Under the "My Inbox" tab, click on "Create New Study"

The application space for your study will open:

• Answer all relevant questions - See further below for guidance specific to each page.
• Keep clicking "Continue" at the bottom right of each page to move to the next page
• When finished with all pages, click the "Finish" button at the bottom right
• The study workspace will appear
• The PI must click "Submit" at left to submit the study to the IRB. 
  • Note: Only the PI may submit the initial new study application in eIRB, as the PI must provide attestations to the integrity of the study submission and their oversight of the research staff and procedures.

To manage the PI and PI Proxies:

• If a study team member generates the initial new study in eIRB, they will be automatically listed as the PI in the study. Ensure that the acting PI is appropriately updated in eIRB as soon as possible, as the study PI must finalize and submit the study.

• The PI may use the "Assign a PI Proxy" activity to assign other study team members who will have PI privileges throughout the rest of the study's lifespan.

Ancillary Review Selection:

The PI or PI Proxy may use the "Manage Ancillary Reviews" in the study workspace, if you know which reviews are needed (see below). The IRB staff will do this otherwise, based on the protocol and smartform responses.

• Department Review: Required for all studies. The IRB staff can select for you, or you may do it as well. In question 1, select your Organization (i.e., department or division) for this spreadsheet of departments with approvers: Departmental Approvers list (Excel file). Do not choose a specific person. Then select "Department Review" from the "Review Type" dropdown. Select "Yes" for "Is a response required?" This will trigger a notification to all approvers associated with that department/division.

  • In eIRB, this review type is listed as "Study Team: Department"
  • Note: SOM:GME students should identify the department of their faculty advisor, as this is the department that will need to complete the ancillary department review.

• Conflict of Interest: Required if an investigator or their immediate family member meets the threshold for financial interest (see Help on the first page of smartform, in question about PI financial interest). and/or if there is any "institutional conflict of interest." In question 1, select "Conflict of Interest." Do not choose a specific person. Then select "Conflict of Interest" from the "Review Type" dropdown. Select "Yes" for "Is a response required?" This will trigger a notification to the COI office. 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.

• Controlled Substance Consult: Required if protocol includes the use of any controlled substances. In question 1, select "Controlled Substance Consult." Do not choose a specific person. Then select "Controlled Substance Consult" from the "Review Type" dropdown. Select "Yes" for "Is a response required?" This will trigger a notification to the Emory Office of Compliance, who will reach out to the study team if needed.

• CHOA Device Review: required if any investigational devices will be used at Children's Healthcare of Atlanta.

• Grady ROC: required for studies that will be conducted fully or partially at a Grady facility. This ancillary review is not required to be issued by Grady prior to IRB approval, since ROC review comes after IRB approval; it simply gives Grady ROC personnel view-only access to the study in eIRB. 
  

• EHSO Biosafety: required if you answered "Yes" to any of the two options under question 2, in the "Ancillary Review Information" section. For more information about human gene transfer studies review this Emory Biosafety Review Guidelines (PDF) or email EHSO at biosafe@emory.edu if you selected the second checkbox (Any of the following: microorganisms or infectious materials; human cells...). 

  NOTE: Question 2 should only be answered "yes" if the material is brought to an Emory research laboratory for further experimentation.  Human blood, blood products or tissue that are shipped to non-Emory laboratories will not require Biosafety ancillary review. 

• To add this ancillary review, select "Biosafety - EHSO" under question 1. Do not choose a specific person. Then select "EHSO - Biosafety" from the "Review Type" dropdown. Select "Yes" for "Is a response required?" This will trigger a notification to the EHSO office.

  • If this is a study conducted only at the VA, do not select this ancillary reviewer as the VA radiation safety officer has a separate process.

• PRMC: Required for all cancer-related research involving Emory faculty/students (not solely studies taking place at Winship Cancer Institute; includes chart reviews, public health studies, surveys, etc.). Please see Winship Clinical Translational Review Committee for information and electronic PRMC submission form (submit to PRMC directly, outside of eIRB; may be done prior to eIRB submission but you must have first created a new study, to generate an eIRB number). In question 1, select "PRMC." Do not choose a specific person. Then select "PRMC (Human Cancer Studies)" from the "Review Type" dropdown. Select "Yes" for "Is a response required?" This will trigger a notification to the PRMC.

• EHSO Radiation Safety: Required for protocols that include any type of radiation, whether scans, radioactive drugs, or radiation therapy. See Study Submission for guidance. In question 1, select "Radiation Safety – EHSO." Do not choose a specific person. Then select "EHSO – Radiation Safety" from the "Review Type" dropdown. Select "Yes" for "Is a response required?" This will trigger a notification to the EHSO office.

  • If this is a study conducted only at the VA, do not select this ancillary reviewer as the VA radiation safety officer has a separate process.

• HESC (Human Embryonic Stem Cell Committee): Required for studies involving Human Embryonic Stem Cells (hESCs) or use of Induced Pluripotent Stem Cells (iPSCs). This review will be required even if the project does not require IRB approval (e.g. because the cells are completely deidentified before being received by Emory). When required, researchers must complete this form: Review Application-ESCROC form (PDF), and sign, scan, and e-mail it to the Office of Research Integrity and Compliance (ORIC) at oric@emory.edu  along with the required attachments.

• Office for Clinical Research eForm: Required for studies that previously required completion of the Office of Quality Review (e.g., CRKP, EML, Clinical Trials Activation Only Form, etc.). IRB approval and consent-form finalization will no longer depend on this approval.

• REMS Consult: Required for all protocols using a drug under a REMS (Risk Evaluation and Mitigation Strategy, imposed by the FDA). In question 1, select "REMS Consult." Do not choose a specific person. Then select "REMS Consult" from the "Review Type" dropdown. Select "Yes" for "Is a response required?" This will trigger a notification to the Emory Office of Compliance, who will reach out to the study team if needed.

• S-I Advisory: For IRB office use only, required when an Emory researcher holds an IND or IDE.

• Title of Study: Title from Protocol/Grant.

• Short title: Choose a short title that you will find helpful to use when referring to your study.

• If using WCG or CIRB: add the prefix "CIRB" or "WCG" before the short title of your study.

• If we will rely on an external IRB besides WGC or CIRB: add the "XIRB" prefix, then the initials of the reviewing IRB (Example: use MUSC for Medical University of South Carolina), and then the short title.

• If Emory is the reviewing IRB for external sites that are enrolling participants (not external collaborators) add the prefix "sIRB" to the short title.

• If this is a chart review: add the prefix "Chart Review" to your short tittle.

• If this is an S-I (Emory Sponsor-Investigator) study: add the prefix "S-I" to your short tittle. An S-I study is a study with an Emory investigator holding IND or IDE.

• Brief Description (Lay Summary): Always use our lay summary requirements.

  • The study will be sent back if the Lay Summary does not include the required elements

• What kind of study is this?

  • Multi-site or Collaborative study: for studies with at least one other non-Emory-affiliated site. Select this option for WCG/CIRB, XIRB and sIRB studies.

  • Single-site study: only taking place at Emory University, Emory Healthcare facilities, or our closely affiliated sites where Emory faculty conduct research (Grady, Atlanta VA, or Children's Healthcare).

  • Will an external IRB act as the IRB of record for this study? Say "Yes" if WCG, NCI CIRB, or if another external IRB will be reviewing your study. Find more information about the reliance process.

    • If Yes, a question will appear regarding the Lead Principal Investigator. This is not a required question, so if not applicable, leave blank.

    • If you selected multi-site or collaborative as the study type, and No for "Will an external IRB act as the IRB of record for this study?", you will be asked if our IRB (Emory) will serve as the single IRB of record for other participating sites. Make sure you have documentation that Emory has agreed to serve as the single IRB of record before marking yes to that question. See the Collaborative Research and External IRBs page for more information. See below for information on how to fill out the "Basic Local Site Information" page.

• Lead Principal Investigator: This is not a required question, and should be left blank if it is a non-Emory person.

• Local Principal Investigator: This defaults to the person who is creating the submission. If not correct, please revise

  • If the PI is leaving/coming from another institution, fill out the PI Transition Form (Excel file) 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.

• Does the local principal investigator have a financial interest related to this research? See the Conflict of Interest Emory Policy (PDF) in addition to the question's help text, to see if you have a financial interest.

• Attach Protocol: make sure you always use our Protocol Templates located in our "Forms and Guidance" panel. If you do not, the IRB will send the submission back for changes.

  • For multisite protocols that cannot be modified, you must use the Supplement to Sponsor Protocol (DOCX) and attach it with the main protocol.

  • If the study will be reviewed by an external IRB, provide the protocol that has already been approved by the reviewing IRB.

  • Note: To receive approval for the use of the Emory IRB short forms, please indicate in your study protocol that you will be enrolling subjects with LEP. Excluding subjects on the base of their lack of English proficiency should be justified in the protocol.

• Basic Local Site Information

  If the study will be reviewed by an external IRB, briefly describe research activities that will be conducted by this site. If this site will perform all procedures included in the protocol, enter "ALL."

  External IRB

  • Question 1 asks for the name of the reviewing IRB. Click on the ellipsis (…) to open the options for IRBs. Filter by "Is Eligible sIRB" and select the radio button for the reviewing IRB.

  • Question 2 asks for an external study ID. Enter the reviewing IRB's study ID number. This should be found on the reviewing IRB approval letter.

  • Question 3 asks for the reason the study should be reviewed by an external IRB. Indicate if the use of a single IRB is required by the NIH Single IRB Mandate, the Revised Common Rule or by the sponsor. If none of these are the reasons, describe why the use of a single IRB is desired.

Add all the funding sources for your study. For example, if the study is funded by NIH, it will be supported by an industry sponsor and Emory will receive a subcontract from the prime awardee institution, include all of these sources in this section.

To add a funding source:

• Click on the "+ Add" and enter the information requested for questions 1 – 3.

  NOTE: to search for a funder, use our "wildcard" character (%) in case it is not worded as you expected in our database.

  • Example: Searching for NIAID...

    • Search as

      %NIAID (so it will pull up even if it appears as "NIH - NIAID")

    • If it does not come up, try

      %Allergies and Infectious

    • If your funding source is not on the list - email us at irb@emory.edu so we can add the name to the list. Please, include the sponsor organization's legal Name, Address, Phone number, and Website/URL (if any). We will not be able to move forward without this information.

    • Our analyst will first review a database to make sure the source is truly not there, then submit a form to ORA-IT to get the source added via OSP. This will need verification from multiple offices before the request is completed.

• Question 4 asks for the funding document from the organization listed in question 1. If your study has a federal grant, you need to upload it here. A Notice of Award (NOA) is not adequate. The IRB must ensure that the aim(s) of the protocol match the aims in the associated grant application. See our guidance entitled Guidance to Connect Grants and IRB Approved Protocols (PDF) for more information.

Repeat the steps for each funding source.

Question 1 asks for the local study team members. This includes anyone who will be involved in the "design, conduct or reporting of the research" at Emory-affiliated sites. Do not add anyone who will neither interact/intervene with research subjects nor work with HIPAA-identifiable private information. Make sure everyone is CITI certified and has obtained their additional training for FDA-regulated clinical studies per Emory Policy, if applicable. Find more information on our Training page.

If using a volunteer in a SOM/SON study, make sure you have received approval by the SOM. Refer to the SOM Internship Program (requires Emory login) before adding to the study.

Question 2 asks to add External team member information.  Follow the guidance posted on our Collaborative Research and External IRBs page.

This is also the place to add collaborators from CHOA, the VA, and Grady who do not have an Emory affiliation.

For studies with international sites:

International collaborators who have access to local ethics review should obtain review locally and not be listed on the Emory IRB smart form.

*People serving locally solely as interpreters or translators do not need to be added because they are not doing human subjects research under the Emory PI's oversight.

Question 1- answer yes if you are using a drug or biologic, FDA approved or not, or are using a food or dietary supplement (DOCX) as a drug (to diagnose, cure, treat or mitigate a disease or condition).

Question 2*- answer yes if using a device (FDA approved or not) in a research study. Also, say yes if you are using a HUD device to treat patients or in a research study. If you are not sure if you should click yes to this question, please review our device guidance (PDF).

NOTE: Ignore the contact information for "Rebecca Rousselle" listed on each site. This was to fill a required field that is not applicable for Emory.

Add all local sites where human subjects research activities will be conducted or overseen by the local investigator.

• Include the locations where Emory data will be physically stored.
  • You do not need to add a "site" for Emory-approved cloud storage (Emory 365 OneDrive), but please include the information in your protocol.
• CHOA, Atlanta VA, Grady, and Emory Proton Therapy Center can be listed as local sites. 
• List other non-Emory sites in an Emory-led study only in the protocol and not in the smart form. 
• International sites: If the Emory study team will conduct research at an international site, please list the site in the smart form, add specific details about this in the protocol, and add supporting materials in "Local Site Documents."

Question 1 - Please add all the drugs (FDA-approved or not) used as part of this research study. Drugs used for treatment not described in the study protocol (for example, a subject may receive pain medicine during their hospital stay, dosing and timing not dictated by the study protocol) do not need to be listed. A new window will pop up when clicking on "+Add":

• Under Question 1, please select the name of the drug from the dropdown menu. If the drug is not listed, you may add it. Please, make sure you check the drug spelling when adding it to the submission as any new drugs added will become part of the eIRB database for others to select.

• Under Question 2, attach Investigational Brochures (for drugs under an IND) or packet inserts (for FDA-approved drugs).

Question 2 - Select if your study will be under an IND. As a reminder, if you are using a medical food or dietary supplement for research, you may need to obtain an IND if the food or supplement is being used as a "drug". See our Dietary Supplements FAQ (DOCX) or our Dietary Supplements and/or Medical Foods Checklist (DOCX)and attach it to the submission (under Attach Files question in this section) if applicable.

If you say Yes to this question, a new question will appear for IND-related information. Select "Sponsor" as the IND holder if this is a person or entity outside Emory. Select "Investigator" if the IND holder is the Emory PI or a person associated with Emory. Please identify the IND holder in the study protocol as well.

"Attach Files" Question - Please attach FDA "may proceed" letters, or the IND exemption form if you are using an approved drug for another indication but you think the use in the study should be IND exempt. If you are a Sponsor Investigator (S-I), attach here your S-I IND Responsibilities Checklist (DOCX) (or S-I IND Responsibilities Checklist Multi-site Trials (DOCX) if applicable). For more information about S-I responsibilities, visit ORIC Emory.

Also, attach the Investigator Checklist for the Use of Schedule I Controlled Substances or the REMS Checklist (DOCX) if applicable.

Question 1 - Add all the devices (FDA-approved or not) that are being studied. Do not include FDA approved devices used per their approved indications to simply collect data about subjects, such as X-rays or MRIs, unless they are being evaluated for safety or effectiveness. Click on "+Add" to add a new device:

• Under Question 1, please select the name of the device from the dropdown menu. If the device is not listed, you may add it. Please, make sure you check the device spelling when adding it to the submission.
• Under Question 2, attach device manuals or other related information for devices
• Select if the device is under a HUD or not.

Question 2 - Select as appropriate. If you are claiming that your study is under an abbreviated IDE or Exempt from IDE requirements, please complete our device checklist and attach it under the "Attach Files" question. If you selected that the study is under an IDE or HDE, a new question will be available:

• Select "Sponsor" as the IDE holder if this is a person or entity outside Emory. Select "Investigator" if the IDE holder is the Emory PI or a person associated with Emory. Please identify the IDE holder in the study protocol as well.

"Attach Files" Question - Please attach FDA "may proceed" letters, or our device checklist if you believe the use of the device should be IDE exempt or is non-significant risk. If you are a Sponsor-Investigator (S-I), attach your S-I IDE Responsibilities Checklist. For more information about S-I responsibilities, visit ORIC Emory.

Question 1 - Attach all consent, consent/HIPAA forms, and assent form using our templates. For studies that will be reviewed by an external IRB, attach the site-specific consent, consent/HIPAA and assent forms created using the model forms already approved by the reviewing IRB. Note that all site-specific changes to the model forms are to be made using tracked changes.

Translated Consent documents – You are not required to submit translated consent/assent documents with the initial submission.  They may be submitted via a modification after the study is approved. Review Emory IRB Policy & Procedure #45, Informed Consent of NON-ENGLISH-SPEAKING PARTICIPANTS for further requirements regarding translated consent/assent documents.

Question 2 - Attach only the most recent versions of all recruitment materials. Review our Advertising and Recruitment: Guidance & Information (DOCX) and Guidelines for Using Social Media to Recruit Research Participants (PDF) for current information.  We have additional recruitment guidance under our study submission guidance page, in the Advertisement, Recruitment and Compensation section.

Question 3 - Other attachments: Attach other related documents as detailed in the submission. For studies that will be reviewed by an external IRB other than WIRB and CIRB, attach reliance documents for your site that may be provided by the reviewing IRB such as the local context review form, institutional profile and reliance agreement.

For research conducted internationally, you will either need to provide your in-country ethics review board approval OR a Letter of Cultural Context; and as required study site permission.

These are Emory specific questions that will allow us to ensure that Emory policies are being followed.  

For the HIPAA-related questions, please review our current guidance (PDF).  All studies need to complete the HIPAA Applicability and Waiver Worksheet (DOCX). If you are not requesting a partial or complete HIPAA waiver, you only need to answer the HIPAA applicability part of the form.  For studies that will be reviewed by an external IRB other than WIRB or CIRB, attach documentation of all waivers granted by the reviewing IRB for the study as a whole (not for the Emory site which has not yet been approved by the reviewing IRB.)

For Ancillary review information, check the section above ("Overview: Submitting a study in eIRB") for more information on what you need if answering "yes" to any of these questions.  

For the "Clinical Research/Expanded Access Only" section: if you are submitting an expanded access request, review our current guidance. The single-use request may not need full IRB approval. You will need to submit the Clinical Research Key Point Summary (CRKP) Checklist via the OCR Clinical Research eForm, found on the OCR website.

Remember the following:

• Modifying Microsoft Word documents (protocol, consents, etc): Tracked changes versions are no longer required
  • The system creates a comparison document for the IRB reviewer.
  • PDF and other document types must come with a tracked version, however.

1. Go to the study, and click on "Create Modification/CR". CR stands for Continuing Review.
2. Select only Continuing Review, or select "Modification and Continuing Review" if also making changes to the study smartform or documents.
   • Do not click on the "Modification and Continuing Review" option if the only modification will be a change in study staff (other than PI change). Study team change Modifications should be submitted separately, if urgent, to avoid a delay while we review the CR submission. A study team member addition/removal can be done in up to 2 business days.
3. To save your entries and move to the next page, click "Continue" 
4. To save your entries and stay on the same page, click "Save" at the bottom in the gray bar
5. While the listed PI, Co-Is and Coordinators can all create and edit a Continuing Review, only the PI or PI Proxy for that study can click "Submit"
   • The PI can add a PI Proxy at any time from the main study workspace, using the "Add PI Proxy" activity (the button is only in the main study workspace, not in the Continuing Review workspace)
6. You do not need to edit the questions in one session. You can save your work and return later

To re-open a Continuing Review request:

1. Log in
2. The pre-submission Continuing Review request will appear in your Inbox
3. Click the "IRB" tab and open the study, then click the Continuing Review Workspace link in the "history"
4. Or click the "IRB" tab and open the study, click "Follow on submissions" tab, then click on the title of the Continuing Review

1. Specify enrollment totals at this investigator's sites

   Please provide the number of subjects who have been consented during the life of the study at all sites under the Emory IRB oversight.

2. Specify enrollment totals at this investigator's sites since last approval

   Please provide the number of subjects who were consented during the last approval period at all sites under the Emory IRB oversight

3. Specify enrollment totals study-wide

   This represents the total number of subjects enrolled at all sites. If this is a single-site study, please put the same information than in question 1.

4. Research milestones: Only select if applies to the local site(s) under the Emory IRB (not study-wide)

   1. Study is permanently closed to enrollment OR was never open for enrollment

   2. All subjects have completed all study-related interventions OR not applicable (e.g. study did not include interventions, no subjects were enrolled): this means you are not doing any other research activity, including data analysis only. See below for other options that may apply to your study. If you are not accessing any PHI and truly your study is ready to be closed out, check this option.

   3. Collection of private identifiable information is complete OR not applicable (no subjects were enrolled): As above, this is the choice if you are not accessing the data anymore, even if for data analysis only.

   4. Analysis of private identifiable information is complete OR not applicable (no subjects were enrolled): analyzing data that has identifiers. Check our list of identifiers for more information.

   5. Remaining study activities are limited to data analysis: this is an option for studies that were enrolling subjects. Only check this option if you are now doing identifiable data analysis.

   6. Study remains active only for long-term follow-up of subjects: again, this is an option that may apply to a study that was enrolling subjects before. This option applies if the activities that are left in the study are a standard of care follow up or for a study that was treating subjects, that the remaining activities are limited to surveys.

   Please see the study closeout eIRB page level help (last accordion section on this page) if the first four options above would be checked off for your study.

5. Do any investigators or research staff have a financial interest related to the research that was not described in a previous application?

   This question ask for any potential conflict of interest. If since the last approval a staff members has reported a conflict of interest, please Conflict of Interest Emory Policy to see if you have a financial interest.

6. Check the items that are true since the last IRB approval for all sites involved in the study

   This question ask for any potential conflict of interest. If since the last approval a staff members has reported a conflict of interest, please Conflict of Interest Emory Policy to see if you have a financial interest.

7. Attach supporting documents: (These must address every item left unchecked in Question 6 above, including safety monitoring information): 

   Attach your Continuing Review Summary of Events (Excel files).If you have a DSMB, attach DSMB reports taking into account the frequency of meetings stated in the protocol (for example if your DSMB meets twice a year, we will expect two reports). If you do not have a DSMB and you are part of a multisite study, attach a communication from the study sponsor/IND or IDE holder/coordinating site stating what is the overall safety status of the study.

   • Do not attach site monitoring reports. Note: Emory has always required teams to submit site monitoring reports, such as those generated by a sponsor's monitor, to the Clinical Trials Audit and Compliance (CTAC) office at ctcompliance@emory.edu. To ensure compliance, the IRB staff will request records showing that all external monitor and/or self-monitoring reports (if self-monitoring is approved as part of a DSMP) have been reviewed by CTAC before the CR is reviewed.

   • Do not attach SAEs from external sites not under the Emory IRB oversight

   • Do not attach a list of protocol deviations- if not reportable, we do not need these reports. If reportable, they should be reported using a reportable new information submission (RNI)

   If you are seeking an IRB acknowledgment of an event(s), submit an RNI instead.

To submit a Modification in eIRB:

1. Go to eIRB (login required) and 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 that once your selections are made, your choices cannot be changed!
   
   To make changes to the study team, you must select "Study team member information"
   
   

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!

• Updating study documents (protocol, consents, etc): Tracked-changes copies are not necessary for Word documents! Instead: 
  • Do NOT “Add” a new document.
    
  • DO NOT "Delete" the currently approved document
    
  • instead, click the “UPDATE” button next to the existing document to upload your clean, revised version (the system can then automatically create a tracked-changes version for IRB staff)

• Use our page-level help for New Study applications if making big changes to the smartform. For example, if adding a drug to the study, review what documentation and information is needed.

• 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.  Note: For study staff modifications, list the names of all study staff being added or removed in the summary. 

Modifications are only required for exempt studies when substantive changes are being made that could alter the original review determination, or the team members needs access in the system.

Examples of substantive changes are changes to:

• subject populations (like adding a vulnerable population category, such as minors or prisoners),
• data collection methods, or
• identifiability of data (where data were previously de-identified).
• addition of Federal funding (see guidance on grant additions)
• Addition of an international study site
• Updates to study staff when the team member needs access in eIRB.

Examples of changes unlikely to alter the Exempt determination (so can be done without further IRB review):

• altering study instruments or recruitment materials
• changing the target enrollment number
• adding fully trained staff (unless a new staff member needs access to the study record in eIRB)
• removing staff

If unsure, log a comment or email your study analyst. (Remember to check the box to notify the IRB coordinator if logging a comment.)

Emory Study Staff Changes:

Study team changes can be done as a stand-alone study staff modification, included with other changes in a modification for "Other parts of the study" or as part of a Modification/Continuing Review (Mod/CR).  

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 choose to add or remove study team members as part of a Mod/CR, it will delay the approval of the study team changes. If the addition of a study team member is urgent, it would be best to submit a separate modification for the study team changes.

Note: For study staff modifications, list the names of all study staff being added or removed in the summary. 

If you want to add an external collaborator to your study, review the guidance on our Collaborative Research page. 

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 consent form(s) if applicable.

If the PI is leaving/coming from another institution, fill out this PI Transition form (Excel file) 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 a new funding source: you MUST use our  Guidance to Connect Grants and IRB Approved Protocols or the Modification will be returned for clarifications.

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 was closed to enrollment and no longer actively treating subjects at the time of sponsor notification, no RNI is required due to a reporting delay unless you are adding a new risk that impacts those that have completed treatment (e.g; late developing risk, failure of device post-implant, etc.)

• If you are submitting documents that include a new or increased risk that requires a revision to the ICF and/or notification to participants, 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 (*)
  • State when you received the information from the sponsor. Our staff will not stop review of the modification but will log a comment asking about any delays in submission. 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.
  • If you are submitting revised/new documents outside of the 10 day timeline, an RNI is required. Please plan to include the root cause of the submission delay in the RNI along with a CAPA plan to prevent this in the future.

(*) 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.)

You can submit an RNI through the study workspace or main dashboard page. If you are using the study workspace. the system will link the RNI to that study. You can add more studies affected under question 7.

1. RNI Short Title

   Remember not to add here any identifiers (such as subject's name, MRN). Use this space to add information you would like to be populated in the post-review letter if your submission requires one. If your RNI is acknowledged, you will not receive a post-review letter.

2. Date you became aware of the information

   We are interested to know when you learned about the event initially. In question 5, include the date when the event occurred as this may be different from the date you initially learned about the event. Please, explain any delays in reporting. As a reminder, you should report an RNI within 10 business days from when you learned about the event initially.

3. Indicate if this event is internal (subject enrolled by Emory personnel or event is under Emory SI or IRB oversight) or external (if not).

   An Internal event is an event experienced by a subject enrolled by Emory research staff; or external but at a site under the oversight of an Emory Sponsor-Investigator; or at a Site under the Emory IRB oversight (our IRB is the IRB of record).

4. Identify the categories that represented the new information

   • Check the options as applicable to your RNI. You may check more than one checkbox. The "risk" and "harm" sections have a lot of options. If your event matches one of those options, you should select that box.

   • Remember: if your event does not affect any of the above, it is not reportable. If you do not need to report but you are reporting per sponsor request, please submit the RNI and explain why this is reported in question 5.

   • For more information about what is reportable, check this chart and see our website under " Forms and Guidance, "Reportable Events".

5. Briefly describe the new information

   Use this section to provide all pertinent details of your event. Please include the following information:

   • Date of when the event occurred
   • Date of when you learned about the event initially
   • Clinical details or details about the issue (redacted as we do not want identifiers)
   • How many subjects were affected by the event, and if so, how many at Emory
   • Up to date enrollment information
   • Root cause of the event
   • Corrective and Preventive Action Plan
   • Sponsor assessment of event Local PI assessment of event (unanticipated problem determination)

   • If this is a breach of confidentiality, let us know if:

     • Was the data PHI?
     • Did the data contain only identifiers with no PHI?
     • Was the data accessed? If so, who accessed the data?
     • Was the data destroyed after the error was identified?
     • Was the information that was released considered as potentially damaging?
     • Was the Confidentiality Officer informed?
     • If so, did they recommend informing the affected subject(s)

   • If you are reporting a consent error, did you use the current approved version of the consent?

     • If you used the wrong version of the consent, indicate the differences between the consent the subject signed and the consent they should have signed.

   • If you are reporting a delay in obtaining approval for study documents (example IB or protocol), please indicate the reasons behind the delay and whether the revisions involved updates to risk information.

     • If the delay involved a sponsor error. please include an email or letter from the sponsor explaining the root cause of their delay and their CAPA plan to prevent this in the future.

6. In the submitter's opinion

   Select as appropriate. If revisions are required, describe them above and submit a study modification for review.

7. Related studies and modifications

   Search for the studies that are affected by this event using the eIRB number. You will only add studies you have access to. The IRB staff may add other studies as appropriate.

8. Attach Files

   Attach here all documents that pertain to this submission, including safety memos, letters from the sponsor, assessment forms, etc. You may show us the changes you are planning to do in your protocol and ICF but for those changes to take place, you need to submit a new modification.

The completion or closure of a study is a change in activity that must be reported to the Emory
IRB at the time that it occurs. If you are planning to close out the study, make sure you are also gathering documents for the closeout, so you are prepared!

You will not find a separate closeout submission. Instead, you need to submit a Continuing Review submission. In order to close the study, you will have to check the first 4 boxes under "Research Milestones" to indicate that all research has now ceased. In addition, you will need to acknowledge that, by submitting this submission with these boxes checked, you will be closing the study.

Don't let your study lapse! You need to submit a continuing review application, even if your study is about to close. Alternatively, you may submit CR submission with the closeout request before study approval expiration. Any premature completion or closure of a study should be reported and explained to the IRB.

You do not need to keep your study open because you need to submit related internal SAEs at the continuing
review. Related, internal SAEs can be reported with the closeout, and they will be part of the closeout record.

It will depend on your study status and sponsor requirements if any. Examples when a study should be left open include:

• Studies still collecting follow up data
• Studies from sponsors still reviewing collected data(for example, asking study teams to verify in the medical record data already collected)
• Studies submitted for publication when is likely that the publisher will ask for additional data
• Studies in data analysis with identified data (containing PHI)
• Studies under an Emory sponsor, that need to submit final IND or IDE reports (after the study ends) to the FDA

In that case, you cannot close the study until the potential unanticipated problem or noncompliance is reviewed by the IRB. Submit a reportable new information (RNI) submission and explain that you are in the process of closing the study.

No, you cannot destroy the collected data. You must consider that the retention of the data will vary per study and that you may be required to hold on data for a long period after study closeout. For example, for FDA studies(using a drug/device/biologic), you cannot destroy the data until 2 years after the drug/device/biologic has been marketed in the US.

In addition, you should check any sponsor requirement for data retention per your protocol or contract.

Emory Retention Policy
Even then, Emory has more strict rules about retention of certain documents, such as ICFs. For more information, see Retention Schedules.

• If you study took place at the VA (or done with VA resources), you need to submit the VA closeout form with the eIRB submission.
• The form can be found at: Closeout Summary for Human Subjects Research (DOCX)
• In addition, you should know that the VA has its own data retention schedule. Please consult with the VA before closing a study.

The IRB cannot reopen your study once it is closed. If you need to re-open your study, you will have to submit a new eIRB submission. Remember: once a study is closed, no additional research activities can take place including data analysis with identified data. You may still access de-identified data after the study is closed and send that type of data to a sponsor if needed. If you are being asked to provide new data, you may need to reopen the study. Check with the IRB office in case you are being asked to provide new data, to help you determine if you need a new eIRB submission (under the HIPAA Privacy rule, this may be allowed if needed for adverse event reporting-see reference below).

Reference: The Privacy Rule also permits, without Authorization, covered entities to make a number of other disclosures of PHI, including disclosures that are required by law, disclosures to public health authorities authorized by law to collect or receive such information for public health activities, and disclosures for adverse event reporting to certain persons subject to the jurisdiction of the FDA (e.g., clinical trial drug sponsors). (See section 164.512 for a description of other disclosures for which Authorization is not required.)