Submit an IACUC Protocol, Amendment or Continuing Review in eSirius 3G


Getting started with eSirius 3G
  • As of March 21, 2016, the IACUC only accepts protocol, amendment and continuing review submissions through the web-based eSirius 3G program
  • All personnel currently listed on an active protocol have access to eSirius 3G
  • New PIs must establish an eSirius account by emailing the IACUC Office with their contact information, including UA NetID
  • eSiruis 3G can be accessed from a UA computer or through a VPN, using your UA NetID and password
  • Chrome or Firefox are the recommended browsers. eSirius 3G does not work with Internet Explorer.

eSirius 3G Manual and Help
  • The eSirius 3G manual for PIs is available on the UAC web pageNote: You will be required to access the file with your UA NetID by clicking on the Staff Login option at the bottom of the page. The manual is found under the Investigator Information, eSirius3G section.
  • Contact the IACUC Office for additional assistance with using eSirius 3G or to request live training.

Submitting an Amendment
  • Note: See the Submit a Personnel Amendment page to make changes to protocol personnel rather than using this process.
  • Log into eSirius 3G
  • Select the PI you wish to perform the amendment for from the pull down list at the top of the screen 
  • Select the Protocol Management option under the Mailbox header
  • On the Protocol Actions tab, click the row with the protocol you wish to amend (row turns yellow)
  • Click the "Start an Amendment" button
  • eSirius only allows one amendment at a time. It is highly recommended that you combine all of your changes into a single amendment rather than submitting serial amendments. You will also be unable to start an amendment if you have started the De Novo Review process.
  • Complete the reason for amendment field and click the "Amend Protocol" button to start the amendment. Note that this field is just the reason for the amendment, not the amendment itself. You will not be able to edit this field once the amendment has been started.
  • The amendment is now listed on the Draft Amendments tab in eSirius. Click the Draft Amendments option under the alert section for Protocol Management on the Mailbox to reveal this tab. Click on the tab and then the protocol number hyperlink for your amendment.
  • The entire protocol is open for modification. Treat the protocol as a living document and make just the modifications that are needed. Do not delete text or options that are still performed on the protocol, as these will be removed from the protocol when the amendment is approved.
  • Email the IACUC Office when the draft amendment is ready for administrative review. Do not submit your draft amendment! Amendments submitted without undergoing administrative review are cancelled.
  • After completion of the administrative review process:
    • The IACUC Office will submit the amendment for you
    • The eSirius system will send an email to the protocol contacts when there are IACUC review comments to address
      • The amendment will now be on the Protocol/Amendment in Review tab. Click the Protocol/Amendment in Review option under the alert section for Protocol Management on the Mailbox to reveal this tab.
      • Click on the Protocol/Amendment in Review tab and then the protocol number hyperlink to open the amendment. Pages with review comments will be indicated on the table of contents.
      • Select the first page with review comments
      • Click on the footnote number in the Review Notes field, or on your original text in the main field, to open a new field named “Changes that have been made in document”. Scroll through the text in this section to locate the matching footnote number from the Reviewer Notes field.
      • Click on the number associated with the review comment to go directly to the appropriate tab for pages with multiple tabs (e.g.: Surgery, Clinical Signs/Moribundity)
      • Make the requested changes in the original field [not the review section] or use the review rebuttal option to let the reviewer know why you have not made a modification
      • Repeat process for all marked pages
      • The table of contents icon will change to a green check mark when the review comments are addressed. All pages marked with a review comment must have a green check before the submission can be routed back to the IACUC.
      • Submit the amendment back to the IACUC using the Submit to IACUC Office page from the table of contents within the amendment. eSirius will automatically notify the IACUC Office that the amendment has been returned. 
    • The eSirius system will send an email to the protocol contacts when the amendment is approved

Submitting a Continuing Review
  • Log into eSirius 3G
  • Select the PI you wish to perform the continuing review for from the pull down list at the top of the screen 
  • Select the Protocol Management option under the Mailbox header
  • Click the Continuing Reviews Due option under the alert section for Protocol Management on the Mailbox
  • Click on the Continuing Reviews Due tab
  • Click on the protocol number hyperlink to open the continuing review
  • Click on the Progress Report tab and complete fields 1 & 2
  • Complete the remaining tabs that are revealed (if any)
  • Save the Continuing Review (Save button at bottom of page)
  • Click the Submit Continuing Review option from the Table of Contents on the left and then the Submit to IACUC button. eSirius will automatically notify the IACUC Office that the continuing review has been submitted. 
  • The eSirius system will send an email to the protocol contacts when there are IACUC review comments to address
    • Click the Continuations in Review option under the alert section for Protocol Management on the Mailbox to reveal this tab
    • Click on the Continuations in Review tab and then the protocol number hyperlink to open the continuing review
    • Modify the tabs as needed or use the review rebuttal option to let the reviewer know why you have not made a modification
    • Submit the continuing review back to the IACUC. eSirius will automatically notify the IACUC Office that the continuing review has been returned.
    • The eSirius system will send an email to the protocol contacts when the continuing review is approved 

Submitting a De Novo Review (renewal)
  • Log into eSirius 3G
  • Select the PI you wish to perform the De Novo review for from the pull down list at the top of the screen 
  • Select the Protocol Management option under the Mailbox header
  • Click the De Novo Reviews Due (Renewal) option under the alert section for Protocol Management on the Mailbox to open this tab
  • Click on the protocol number hyperlink for your protocol on the De Novo Reviews Due (Renewal) tab. Note: you will be unable to start the De Novo Review process if you have an amendment in progress. Draft amendments should be cancelled and the changes incorporated into the renewal protocol. Amendments in review must complete the review process. 
  • Complete the progress report field and select a status for the protocol. Save the page and select the Start Renewal button. You may edit the progress report field after you start the renewal if needed.
  • The entire protocol is now open for revision. Keep in mind that the text you are looking at is for the past three years. Update so that the information provided covers the work you plan to perform over the next three years.
  • Once you have started your draft protocol, the draft is displayed on the Draft Protocol tab. Click the Draft Protocols option under the alert section for Protocol Management on the Mailbox to reveal this tab.
  • You may reenter the protocol by clicking the protocol number hyperlink
  • You will need to modify each page of the protocol so that you get a green check mark next to the page name on the Table of Contents
  • Attach a full copy of all NIH/PHS grants to the Federal Funding page
  • As applicable, attach a new Breeding Addendum to the Breeding page and new Compounding SOPs to the Exceptions page. Forms can be found below.
  • Email the IACUC Office when the draft protocol is ready for administrative review. Submitted protocols must remain on the Draft Protocols tab until the administrative review process is complete.
  • After completion of the administrative review process:
    • The PI will be required to submit the protocol. This is the only time that the PI must submit a document in eSirius 3G.
    • Click the Submit to IACUC Office from the Table of Contents inside the protocol document and then the Submit to IACUC button. eSirius will automatically notify the IACUC Office that the protocol has been submitted. 
    • The remaining protocol review process is the same as the amendment review process

Submitting a New Protocol
  • Note: Contact the IACUC Office to determine if the new protocol could be an amendment instead. Protocols, which should be amendments, are cancelled.
  • Log into eSirius 3G
  • Select the PI you wish to submit the new protocol for from the pull down list at the top of the screen 
  • Select the Protocol Management option under the Mailbox header
  • On the Protocol Actions tab:
    • Click the Start a New Protocol Application button to start a protocol from scratch
    • Click the row with the protocol you wish to copy (row turns yellow) and click on the Copy Protocol to New Document button to make a copy of an existing approved protocol.
  • For protocols not started from a copy, select all options that apply to your work on the Protocol Activities/Species page. Additional information can be found on the help icons [blue question mark]. Selections made on this page will control what the rest of the protocol will look like.
  • Complete all pages in the protocol so that you have a green check mark next to the page name on the Table of Contents.
  • The remainder of the process is the same as submitting a De Novo Review

Viewing the Approved Protocol Document in eSirius
  • Log into eSirius 3G
  • Select the PI whose protocol you wish to view from the pull down list at the top of the screen 
  • Select the Protocol Management option under the Mailbox header
  • On the Protocol Actions tab, click the row with the protocol you wish to view (row turns yellow)
  • Click the "View Approved Protocol" button
  • Click the hyperlinked protocol number for the version at the top of the list. This will be the currently approved version of the protocol.
  • You are now viewing the full protocol document
  • To print the protocol, select "Ctrl" + "P" to reveal the print menu. You may now either print a hard copy or a PDF of the protocol. Select "Save as PDF" (Chrome) or "Adobe PDF" (Firefox) as the printer to save a PDF version of the protocol to your computer.
  • All protocol documents are attached on the "Protocol Attachments" page listed at the bottom of the Table of Contents. See the instructions below for tips on how to open or save the attached documents.

eSirius Attachments
 
You will need Acrobat Reader version 8.0 or higher to use the PDF forms. When accessing the forms to avoid browser issues, right click on the hyperlink and select save target as or save link as to save the file directly to your hard drive. After saving, close the web document and open the saved document. The same process must be used in eSirius to open the attachments when using Chrome as the browser or to save the attachments (Chrome or Firefox).
 
PDF forms
Compounding SOPs
Satellite Facilities
Client Owned Animals

 

     
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