Insight and eIRB System Help

Insight: See Emory Insight Sharepoint and Brainier training

To create a new study in Insight:

See Insight Brainier training for technical steps. 

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

Ancillary Review Information:

Insight: Ancillary reviews are set up in the Insight system based on responses to form questions in Insight. The same ancillary reviews below apply, but they are mostly managed within the Insight system. 

• Department Chair Review: Required for all studies and automatically triggered when the PI submits the study to Dept. Chair Review. This is a required signoff before the IRB receives the submission for screening.

• Conflict of Interest: Required if an investigator or their immediate family member meets the threshold for financial interest and/or if there is any "institutional conflict of interest." There are questions in Insight (Investigator Disclosure Form) that will trigger the need for a COI review. 

• Controlled Substance Consult: Required if protocol includes the use of any controlled substances and is automatically triggered based on responses in Insight forms related to drugs (answering "yes" to if the study involves a schedule I controlled substances). 

• 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.
  

• EHSO Biosafety: required if your study involves any of the following: 

  • Recombinant or synthetic nucleic acids (DNA, RNA, CRISPR, oligonucleotides, etc.),
  • Deliberate transfer of recombinant or synthetic nucleic acids into human research participants

  This review is automatically triggered when the Insight question that captures the details above is answered "yes". For more information about human gene transfer studies review this Emory Biosafety Review Guidelines (PDF) or email EHSO at biosafe@emory.edu.

  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. 

  • 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). 

• EHSO Radiation Safety: Required for protocols that include any type of radiation, whether scans, radioactive drugs, or radiation therapy. This ancillary review is triggered based on responses in the Insight form related to the use of radiation. 

  • 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) and is automatically triggered based on responses in Insight forms related to drugs (answering "yes" to if the study involves a drug under a REMS).  

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

Insight: The questions in the form gather the essential information. As you answer questions, additional relevant questions may appear. 

• Title: Title from Protocol/Grant.

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

  • For Cede Review: For the short study title, use the prefix XIRB and then the name of the external IRB followed by the short title of the study. Examples: XIRB: WCG IRB: short title, XIRB: Advarra: short tile.

  • 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 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

• Exempt Categories Question:

• Only select the categories if you are able to confirm that the content applies to the entire study and not just a portion of the study. Most studies will select "None of the above" and answer the remaining questions that populate. 
• Remaining questions in Study Overview:
  • Answer these questions accurately based on the study details. Additional questions may populate based on prior responses and the answers on the Study Overview form will ultimately determine the require form set for the particular study.

Insight: See Insight Sharepoint and Insight Brainier training related to linking agreements. 

Funding is based on what is currently in Agreements and Compass platforms, linked to your IRB number. If you think the funding information is not accurate in Insight, update it when you do your next Amendment. 

To add a funding source in Insight:

• First select “Search Insight Agreements for the funding proposal…” and search for the funding entry to link to the agreements record. 
• If the correct funding source is not there, go back to the funding form where you initially selected that option and select “No funding proposal in Insight Agreements.” Then, fill in the information requested. 
• If the study is not funded, select "None". 

Insight: See the Brainier Insight training for adding study team members in the humans module. 

eIRB Legacy System: 

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.

Insight: The forms are designed to gather the essential drug and device information. 

eIRB Legacy System: 

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).

Insight: See Insight: Creating a Research Protocol in Insight Submitters Curriculum in Brainier Insight training

eIRB Legacy System: 

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."

Insight: Complete the questions related to drugs within the Insight forms. Utilize the drop down to find the drugs for your study. Only add new if you can't find your drug in the drop down. Attach documents as needed to the main attachment space of the study. 

eIRB Legacy System: 

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.

Insight System: Complete the questions related to devices within the Insight forms. Utilize the drop down to find the devices for your study. Only add new if you can't find your device in the drop down. Attach documents as needed to the main attachment space of the study. 

eIRB Legacy System: 

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.

Insight System: 

Attach all study documents in the main attachments section accessible on the left. Utilize the drop down menu for the document type to identify the type of document. 

eIRB Legacy System: 

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.

Insight: 

The forms questions will gather the information needed related to waivers and ancillary considerations. 

eIRB Legacy System: 

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.

Insight: The system does not create tracked changes. Tracked and clean copies will be needed in Insight when making revisions. 

eIRB Legacy System: 

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.

Insight:

• Continuing Review: Submit a continuing review by selecting create continuing review or continuing review/amendment as applicable from the left hand menu while in your study space. The forms will gather the required questions. You will upload the attachments in the main attachment space. 
• For exempt and expedited studies that do not require a continuing review, you can complete your exempt/expedited check in by selecting that option from the left hand menu within the study space. Complete the require questions and submit. 

eIRB Legacy System:

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

Insight: See the questions in the continuing review, exempt, and expedited check in in Insight as well as instructional material as applicable. Complete the form questions and submit. 

eIRB Legacy System: 

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.

Insight:

• To create an amendment, select Create Amendment on the left hand menu.
• Please note for migrated studies, many additional fields may be required prior to submission. 
• For document revisions, you will need to upload the tracked and clean version.  

Amendments 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.

In some cases, a modification may be needed to add required template language that was not included at the time of initial review.

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.
• Updates to study documents to include required template language (e.g., ResearchMatch, Greenphire as a method of compensation)

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, please email your study analyst. 

Insight: 

Emory IRB will now only require you to update the study team list at Continuing Review or Expedited Check-In (the same as we've been doing for external-IRB studies). You may still update your study team at any time via Insight's automated process, but it is no longer required. Note:The IRB will need details on the study team at the time of initial review.

Note on VA Exceptions: The VA has not adopted this policy. Any study team updates for VA studies should be made in real-time. 

Note on Grady Exceptions: Grady study team members needing access to EPIC will need to complete stidy team updates in real-time.

Note of Children's Heathcare of Atlanta: Children's staff can be listed on the external personnel spreadsheet (titled something like "CHOA personnel list") that is added via attachment. If they need to work on the study in Insight they will require a sponsored account and training will need to be added by IRB staff. 

Reminder: PI's have full responsibility for ensuring their study teams complete all required training before doing human subjects research, and we will continue to verify training during post-approval monitoring. See the external collaborator page for external collaborator considerations. 

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

PI Changes: 

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.

Insight: See Brainier Insight training related to agreements. 

Insight:

If you or your sponsor (as applicable) are implementing changes to the study, you are required to update your study documents using an amendment 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 "other event" 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 amendment approval letter for the new documents, the IRB needs to receive a response about the delay via logged comment and the submission of an "other event" if needed.
  • If you are submitting revised/new documents outside of the 10 day timeline, an "other event" 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 "other event" 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.)

Insight: You can submit an Other Event (OE) through the study workspace. 

The other event form is designed to populate based on your responses. The form is designed to gather all of the information needed. If ther are relevant attachments, you will add those in the main study space. As always, remove/redact all identifiers prior to uploading into Insight. The form will provide you guidance about what to include and attach. For more information about what is reportable, review our Reportable Information page.

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).

Other Event Short Title

Remember not to add here any identifiers (such as subject's name, MRN). 

Briefly describe the new information

Use this section to provide all pertinent details of your event that aren't already addressed in the questions in the form. Please redact all participant identifiers.

PI's assessment of the event in relation to participant's rights, safety, welfare, willingness to continue study participation, or the integrity of the research data. 

Indicate if the event is internal or external. The question provides guidance on these terms. 

Select the type of event being reported to the IRB. More questions will appear depending on your selection. 

Indicate the study status. 

Indicate the number of participants affected and total number enrolled. 

Dates: The form asks you the date you became aware and the date of the event you are reporting.

Indicate if the event is being reported per reporting requirements. If not, provide details and capa.

Indicate if the event suggests increased risk of harm or necessitate changes to protocol or consent.  

Indicate whether current study participants should be notified of the event. 

Provide a corrective and preventative action plan or safety plan. 

Indicate how the team learned of the event. 

Provide the relevant information from study documents that relates to the event. For example, if you are reporting a protocol deviation, indicate what in the protocol was deviated from. 

Indicate if you have had similar reportable events in this study previously.  

Attach Files

Attach in the main attachment space with the attachment type labeled as 'other event' 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 amendment. Redact all participant identifiers prior to uploading. 

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!

Closeouts are done via "Create Continuing Review" or "Create Expedited/Exempt Check-in." If your study was migrated from eIRB but has not be updated previously, it will force you to complete the Insight forms via an Amendment.

Please contact our IRB listserv so we can help you close it out administratively if that is appropriate.

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 Insight 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 Insight 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.)