Separate Amendment and Continuing Review forms have been developed for existing protocols. The ePortfolio will not allow Amendment or Continuing Review submissions for protocols not initiated on the ePortfolio.

Currently, there are no changes to Departmental Scientific Review processes; however, in the future, there may be an opportunity to upgrade the scientific review process.

Yes, you may wait until the ePortfolio goes live to submit, or you may submit the protocol using the current suite of applications. Note: The HSP and current suite of forms may be submitted until September 30, 2020, and the IPR and PRAF will still be accepted until November 30, 2020.

The Personnel eForm will remain a standalone document so it can be independent of the ePortfolio. No significant changes are being made to the Personnel eForm at this time.

No signatures on IRB eForms are required, but the PI will receive an email confirming submission of applications. Note that the Protocol Oversight Review Form must be signed.

Consent forms will continue to be uploaded as Microsoft Word documents, with tracked and clean copies submitted when changes are requested.

The PI will receive an automatic notice when an IRAP submission has been submitted to the IRB.

Students will submit their applications to the IRB using the ePortfolio.

Ancillary approvals will be submitted as an attachment within the ePortfolio.

Responses to communications to the ePortfolio will look somewhat different. Administrative Pre-Review letters and Determination Letters will be formatted in a table with a cell for your response. When you complete your response, please upload the Response as an attachment to the ePortfolio.

The ePortfolio is projected to reduce turnaround times, and automating current manual processes will allow redeployment of IRB staff to more value-added tasks.

InfoEd, the commercial vendor that designed IRAP, uses an eForm builder, so the software was immediately available; however, UAB partnered with another institution that uses InfoEd to obtain the basic structure of the ePortfolio.

Anything uploaded within an eForm (e.g., the ePortfolio, Amendment eForm, or Continuing Review eForm) will not require a naming convention. Applications uploaded prior to September 30 using the HSP or Continuing Reviews and Amendments uploaded prior to November 30 using the Microsoft Word suite of applications will require naming conventions.

Yes, there is a save feature, so you may leave the ePortfolio and complete later. It is recommended that you save often to avoid timing out and losing work. You will need to remember the protocol number so you can find the submission again.

Yes, you can save the ePortfolio as a PDF and print the document.

Any investigator listed on the protocol as well as the PI’s delegates have access to the ePortfolio.

Yes, amendments are made directly to the ePortfolio. You will not have to start over each time.

Your existing IRAP delegates will remain unchanged.

There are definitions of each expedited or exempt category inside the ePortfolio and you may select the appropriate category or categories.

Not at this time. If you have an existing protocol, we are asking you not to complete the ePortfolio until further notice.

You can save the ePortfolio as a PDF and send it to your department reviewer along with an unsigned copy of the PORF.

Delegates can complete the ePortfolio, click save, and notify the PI the ePortfolio draft is complete for him/her to review and submit.

IRB staff will pull the next in line for the submission type that is in their area of expertise.

A copy of the training presentation is available HERE.

If the pre-review has been initiated, you can email the IRB staff reviewer who completed your pre-review for that submission.

No changes to the expiration date process is occurring.

Yes, you can submit multiple applications for different IRB protocols; however, you may only have one open Continuing Review or Amendment submission in a single protocol at a time.

The OIRB will stop accepting the HSP on September 30, 2020.

Because the form uses branching logic, questions must be answered in the order they are presented.

You will not receive a notification until the IRB staff member has completed the pre-review.

Yes, the form is similar.

No, only one investigator can work in the same form at the same time. If multiple investigators use the form simultaneously, the form may lose data for one or more investigators. However, multiple users may contribute to the same form when logged in at different times.