Yes, they will be able to access prior submissions. For prior submissions in eIRB, only dates and approval status are visible in eIRB, without details. For new eIRB protocols, future team members will have full access to submission history. 

Yes, there is greater flexibility around this. You will be able to identify more than three study contacts. “Study Contact” will no longer be a personnel role. It will be a permission that you set for each study personnel. It is already defaulted for the PI, research coordinator, and regulatory manager roles. You will want to assign study contact permissions to anyone that you want to receive communications about the application. Additionally, study contact is no longer tied to edit permissions. This is a separate permission in eIRB. 

Anyone who is given edit access at the time of adding them in eIRB may address the comments and make changes to the application. Study contact and edit access are no longer tied together in eIRB to allow more flexibility. Designating someone as a study contact will ensure they receive communications about the study. Designating someone as having edit access gives them edit access to the application. 

Yes, external investigators may be added to the research team panel. Adding them via this mechanism allows their research engagement to be covered by the Penn IRB, assuming they do not have their own IRB to rely on.

This will NOT give them a user profile with access to eIRB. If an external person needs a user profile in order to access to edit/view eIRB, the IRB would have to manually create an eIRB account for them.  Please contact the eIRB help desk in this situation. 

PLEASE NOTE: Please consult with Patrick Stanko, Reliance Manager, before adding external investigators.

NOTE: Institutional SOPs must be followed. For example, School of Medicine SOP 411 states: providers or staff who are not directly employed by a Penn Medicine entity or the University of Pennsylvania may not engage in clinical research at a Penn Medicine facility. This is inclusive of all research roles, i.e., Principal Investigator (PI), sub-Investigator (sub-I), trainee, clinical research support, or key personnel roles.

The system will send a in-system task and send follow up emails. For non-Penn users, you can upload a training document.

Any personnel can run reports for the studies on which they are listed as personnel. 

There is no limit to the number of Study Contacts on a study.

Yes; Please ensure that you submit a full amendment to change the PI.

Yes, you will be able to view a history of all personnel updates. If a review is required, you will be notified in the system and through an email notification.

If an individual is showing as inactive [i.e., they have an (i) after their name] or you can’t otherwise add a Penn individual, please request a research affiliation via the form. Please note that temporary staff are not automatically granted eIRB access. A research affiliation is always required. 

Upon Department Chair sign off, ancillary review groups will receive a task for their review in eIRB. Ancillary committees will also have access to view submissions prior to this point if you need to consult with them prior to submission. Ancillary committee reviews and approvals (including, as applicable approval letters) will be documented in eIRB. At this time, there are no plans to migrate study documents from eIRB to other application. It is recommended that you consult with these committees to determine if they will be any changes in their submission requirements. 

RIS number is not a mandatory field. However, contracting groups will search by RIS number in eIRB to find the associated IRB protocol. They may require you to enter it for their purposes. The IRB recommends that you add it via an amendment when you have the number to facilitate communications with contracting groups.

It is a required field. If you don’t have the UPCC number at the time of IRB submission, you can enter “Pending” in field within the HRPP panel.

Please click the link below for eIRB guides.

The vendor designed the IRB module with two submission types: stages and protocol updates.

Stages are considered to be initial submissions, amendments, and continuing reviews. The system prevents more than one stage from being submitted at a time. The exception would be a combined continuing review and amendment submission.

Protocol updates are other submissions that do not significantly change the protocol nor update the review cycle. These include deviations, reportable events, and exception requests. This system allows for these submissions to be submitted when a stage submissions is pending IRB review. It also allows for more than one of these submission types to be submitted at once.

Annual check-ins and closures are also protocol update submission types.

Yes. The system allows you to move between panels even if not all questions are answered. 

Yes, look for the light blue box at the top of the IRB application entitled New Amendment or Continuing Review. Click request. In the drop down, select Continuing Review with Amendment. This will open up the IRB application for editing and generate the continuing review form to be completed. You cannot submit a continuing review and amendment as separate submissions at the same time. 

No. The application will be locked when someone else is already in the application. It is important that you close the protocol application window when you are not actively working within it to allow other study team members, the IRB and others the ability to work within the protocol.

Funding and Funding Sponsor is required to be in eIRB. Additionally, the funding proposal should be linked in eIRB in the Connected Projects Panel.

If you do not have this information at the time of initial review, select “Pending Proposal” to the question “Indicate if any part of your project is funded” within the Connect Projects panel. List the funding sponsor in the planned sponsor field.

After IRB approval, study team members with edit access can update this section and link a proposal without submitting an amendment and prompting review by the IRB. Given this, with eIRB launch, IRB staff will begin enforcing updating these fields. 

Yes. Once the protocol has been received by the IRB and has a status of IRB Review Pending or Preapproval Requirements the Request Mid-Review Edits option will appear.

To request that the IRB return the application, open the IRB application for your protocol. Look for the light blue box at the top right of the eIRB screen that says Request Mid-Review Edits. This will send a request to the IRB staff member assigned. The IRB will decide whether it is appropriate to return the application depending on the state of the review.

This is not available if the protocol is pending PI approval. If the submission is pending PI approval one must either wait until the PI signs off or email the eIRB help desk to return the submission. In a future release, the PI will be given the option to reject the submission.

Yes, you can do this whether the protocol is open or closed. Within the protocol you want to copy, look for the light blue box at the top of the protocol that says “Copy Protocol.” Click copy. You can copy a protocol in its entirety, or you can select which sections of the application form you would like to copy.

When a protocol is in an expired or completed state, the protocol is locked to further edits. Click Request in the Request to Reopen blue box at the top of the application.

After you have done this, you must create a submission to the IRB. Failure to do so will lead to the submission reverting back to expired or completed the following day.

• If the protocol was completed, please submit an amendment to the IRB explaining why you are reopening the protocol.
• If the protocol expired, please submit a continuing review application. 
• If the protocol is relying on an external IRB and expired, please submit an annual check-in form. 

Please check the following:

1. Scroll the top of the application in eIRB. Ensure there is not a yellow box indicating someone else is editing or viewing the protocol.
2. Confirm you have edit access in the edit access column of the research team panel. If you cannot see this, try zooming out OR click the + button next to your role to expand to show other columns. If you do not have edit access, someone else on the protocol with edit access should give you edit access. 
3. Check to see if the protocol is approved? If so, the protocol will be locked, and you need to request an amendment in order to unlock it. Look for the Amendment blue button at the top of the application. 

These should be submitted via an annual check-in submission. Please do not submit these via an amendment! If you fail to complete annual check-ins for three consecutive years, the study will automatically close in eIRB. Please submit these promptly once received by the IRB of Record (within 30 days of study expiration). 

You will need to submit a combined CR / amendment to update the Study Monitoring and Quality Control questions in the Risks and Benefits panel to correct this. 

The safety monitoring and quality control questions only populate when required, which is generally for protocols requiring full board review. 

eIRB has integrated in-system notifications and also generates tasks. The system also sends out emails for notifications and tasks. You will have some control over what notifications and emails you can opt out of.  For example, when it is time to submit a continuing review, the system will generate a task to do so. If the task is not completed, the system will send out notification reminders via email and within the system. 

Yes, you’ll receive email notifications and in-app notifications.

1. Click the edit button in the action column to edit the PI.
2. In the Researcher Box, click the X to remove the PI.
3. Enter the new PI.

If the new PI does not have an account established and they are not showing as selectable, you must first add them into another role in the Research team panel. This will establish their account. Delete them from the protocol – their account will remain. Then follow steps 1-3 above.

Click the edit button in the action column to edit the person. Uncheck the primary contact box and the edit checkbox will be unlocked. Reset the edit checkbox and then recheck the primary contact box (as needed).

Yes, relying sites should be added in the relying site panel.

Yes, the sIRB contact, which is designated in the parent protocol Research Team panel, may submit on behalf of relying sites.

Yes, submissions from the relying sites get prompted for a quality check by the designated Penn sIRB contact. This happens before the submission goes to the IRB.

Relying sites will not see a button to submit a continuing review until the continuing review on the parent record is created. Additionally, the relying site must be in an approved status.

Relying site data was not able to migrated from the legacy system. Yes, the IRB can assist with adding sites, but we require additional information in order to do so. You will still need to ensure completeness of your sites after they are added.

If you would like help with adding them, please complete the linked form. 

If the relying site team wishes to receive approval letters for their site via email, at least one person must activate their eIRB account.

Yes, please email the eIRB help desk and the help desk can reset the account.

You may use any authenticator app. The vendor recommends Google, but Penn uses Duo. If you already use Duo for work, you may use that. 

Open the authenticator app that you selected when you set up your account. Find the generated code in the app that is attached to the email you are using for eIRB. Enter that code.

No, all PI approvals for relying sites route to the Penn PI.

Latest status gives the approval status of the most recent eIRB protocol stage. Protocol overall status is the approval status of the protocol as a whole. Click below see a detailed explanation of all IRB statuses.

For stage submissions, you can view this in the Requirements Table panel. This will tell you whether the submission is pending PI approval, another ancillary committee review, and where it may be with the IRB office.

For protocol update submissions, you can view the status in the respective panel.

Ready to Start means that a requirement is ready and waiting to be completed.

Not Ready to Start means that a prior requirement needs to be fulfilled before the current requirement may commence.

For example, if the IRB Admin Assignment is Ready to Start – this means that the protocol is pending IRB staff assignment. IRB Admin Processing will remain Not Ready to Start until the assignment is completed.

Yes, eIRB will provide increased transparency around the IRB review process and in cases where the level of review changes for a protocol. Underneath the protocol number and PI name at the top of the protocol, the table will display the review type of the protocol. If the level of review changes this will update in real time.

For stage submissions, refer to the Requirements table for the system predicted level of review.

Yes. You can download any revision as a PDF. Additionally, it gives you the option to select which sections/panels to include in the generated PDF. To download a PDF:

1. Open the protocol
2. Go to the top right corner – and click the cloud icon.
3. Select the double arrow to move all the panels into the PDF.
4. Move the IRB correspondence back to unselect it if you do not want to download all of the IRB letters in the PDF.
5. Click download. 

NOTE: This currently doesn’t work with protocol update submissions (Deviations, etc.), nor the amendment form. This will be corrected in a future release. If you need to PDF a copy of the amendment form and/or protocol update submissions, the vendor recommends the Awesome Screenshot browser extension. See link for guide.

Yes. Follow the instructions above for downloading the stage / revision as a PDF.

Open the document in Adobe and the documents should all be attached under the Attachments icon. NOTE: This will not work in a browser window.

You can select all of the attachments and save them elsewhere if you wish. You can also click each one to open it.

You will find your documents in the panel next to the field where you uploaded them. 

The submission numbers for stage submissions (initial, continuing review, and amendments) appear in the Requirements panel under “Submission History,” where it is listed as the revision number.The submission numbers for updates (exceptions, deviations, and reportable events) are within their respective panels.

 Go to the eIRB menu, and click on Search IRB Protocols. In the Filter Search panel, ensure that you check the box next to “Include Inactive.” This will include protocols that are expired, or that were previously closed.

If you are looking for a specific protocol, you can enter the protocol number directly within the Go to Protocol panel in the Protocol # or Title field. When the protocol pops up, click on it, and it will take you directly to that protocol. 

For stage submissions, go to the Requirements table panel by using the left hand menu to navigate. Find the prior submission. Find the magnifying glass icon on the right hand side of the table for that submission. Click the magnifying glass to view the prior submission.

For protocol update submissions, you can view all prior submissions in the respective panel(s).NOTE: For studies migrated from the legacy system, eIRB incompletes an incomplete history. To see details about submissions submitted in the legacy system, you must utilize HSERA or contact the IRB.

The IRB defines a student project as a study that is written, led, and conducted by a student with faculty mentor oversight. This would include, but is not limited to, a PhD dissertation, Master’s thesis, etc. This could also include clinical residency projects as well. In these situations, the question should be answered no. The faculty mentor should be listed as the PI with the student listed as the Co-PI or Sub-I.