On-line IRB and IACUC Protocol Submission Gateway

The Office for the Vice President for Research (OVPR) has initiated a project to implement eProtocol software to streamline the University of Notre Dame’s Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC) protocol submission and review.

eProtocol software provides a paperless, electronic method for the submission, tracking, and review of information related to human subjects activities and animal care. PIs can create, edit, clone and submit protocols from any computer at any time. All documents associated with the protocol will be available online (including the approval letter) for all personnel listed on the protocol.

eProtocol software is intended to improve the efficiencies of Notre Dame’s research compliance programs.

Click here to download eProtocol user guide

>>>Click HERE To Enter eProtocol<<<

The new system will replace paper and email submissions.

Below you will find answers to some frequently asked questions regarding the design and deployment of the new web application. If you have a question that is not listed below, please call the University of Notre Dame eProtocol Administrator at (574) 631-1389 or send an email to Ms. Nakesha Alexander, Nakesha.Alexander.65@nd.edu.

Frequently Asked Questions

1. What is eProtocol?
2. Who will have access to the eProtocol system?
3. Who will be required to use this system?
4. When will the new system be available?
5. How will the new system save me time?
6. Will paper forms and signatures still be involved in the IRB process?
7. How much of my existing study paperwork will be transferred into the new system?
8. What web browsers will be supported?
9. Will training be available for the new system?
10. Can my external collaborators access the system?
11. How will this system streamline the compliance administrative process?
12. How will the new system affect the review process?

1. What is eProtocol?

eProtocol is an industry leader for electronic research compliance management systems. Following an in-depth review process of various compliance systems and broad-based vetting among University of Notre Dame faculty and researchers, eProtocol was determined to be the best platform for electronic research compliance.

2. Who will have access to the eProtocol system?

All university researchers (e.g., faculty, students, and staff) have access to eProtocol. University NetIDs will be required in order to use the system. Individuals who are not currently affiliated with Notre Dame can request affiliate status from the Director of Research Compliance.

3. Who will be required to use this system?

As of March 19, 2012, all university researchers will be required to use the eProtocol system. For the IRB, this includes exempt, expedited, and full board proposals. Paper and email copies of research protocols will no longer be accepted.

4. When will the new system be available?

The current projected launch of this system is January 15, 2012. Pre-production testing is currently in progress.

5. How will the new system save me time?

The benefits of the system will be seen through more efficient routing of the paperwork between relevant parties. Feedback will be instant and email notifications will provide university researchers links with which to access, update and review their material immediately.

6. Will paper forms and signatures still be involved in the IRB process?

No. To enhance electronic reporting and audit capabilities, as well as cut down on paper archives, there will no longer be any paper or pdf forms. Your NetID, or other system credentials, will serve as an electronic signature for filings.

7. How much of my existing study paperwork will be transferred into the new system?

There are currently no plans to import old material into the system, though existing paper copies of research protocols will be retained. When your study is due for continuing review, you will need to enter a complete set of information for the study (i.e., the information found on the new protocol submission application form). We realize that this will be a time consuming process at first, but it will result in speedy renewals (during the renewal process you will only need to pull up the study in the system and provide the necessary updates), and efficient routing of your paperwork between relevant parties.

8. What web browsers will be supported?

All major browsers are supported by the system, including Internet Explorer, Firefox, Safari. Please note that you should always work from original web-address, as working from a bookmarked eProtocol web-address will result in an error message.

9. Will training be available for the new system?

Yes. The OVPR will be launching a multi-site training initiative in Spring 2012 to familiarize the research community with the new system.

10. Can my external collaborators access the system?

External collaborators may be given temporary access to the University of Notre Dame eProtocol system. Such an assignment is made by the eProtocol Administrator.

11. How will this system streamline the compliance administrative process?

The eProtocol system provides document management and routing functionality to steer paperwork immediately to its intended recipient, and present that individual with relevant menus to operate quickly on the material. Enhanced audit functionality will allow the IRB or IACUC to call up any past change to the paperwork and act upon it. Automated email notifications will be used to communicate with both the research community, reviewers and the IRB staff. These notices will quickly move information along its intended path without delay.

12. How will the new system affect the review process?

First, the physical step of moving paperwork around will disappear, providing a clear increase in process efficiency. Second, reviewers will have the entire protocol and its history at their fingertips, which will enable them to make informed decisions quickly. Third, researchers and their teams will be able to track the progress of their submission in real time. The system will ensure correct routing of correspondence resulting from reviews and clean, up to date consent forms will be available instantly.