Protocol Summary Integration FAQ

The IRB announced in late 2011 that the information collected in the Protocol/Research Summary forms was being integrated into the ERICA application, such that the Protocol/Research Summary would no longer be required as of early 2012. This page has been designed to serve as a primary information and navigation hub for topics related to the Protocol Summary Integration and January 2012 IRB update.

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Frequently-Asked Integration Questions

How do the new questions relate to my current Protocol/Research Summary?

Most of the new questions can be completed simply by cutting and pasting sections from your currently approved Summary document. Please move the information from your Summary into the following questions in the New Study Application:

  • Background and Introduction: Add the information from this section to the Contacts and Title Page, #10.
  • Purpose and Objectives: Add the information from this section to the Contacts and Title Page, #9.
  • Participant Selection Criteria: Add the information from this section to the Participants Page, all questions.
  • Design: Add the information from this section to the Study Information Page, #1.
  • Study Procedures: Add the information from this section to the Study Information Page, #6.
  • Statistical Methods, Data Analysis, and Interpretation: Add the information from this section to the Study Information Page, #9.
  • Administrative Responsibilities:Add the information from this section to the
    • Recruitment: Add the information from this section to the Study Information Page, #4b.
    • Resources and Responsibilities: Add information from this section to the Resources and Responsibilities Page, all questions.
  • References: Add the information from this section to a blank Word document and attach your references to the Documents and Attachments Page under “Literature Cited/References”.

After entering your Summary document into the application, you should delete the document from your application if the option is available. If the option is not available to you in ERICA, please note that the Summary will not be processed with your final approval. Several other new questions have also been added as a result of the system update. These questions are also now required in order for a submission to the IRB to be considered complete.

Please use the “Continue” button in ERICA to work through all of the pages and ensure all required questions have been completed. If you receive an error when you attempt to re-submit your application to the IRB, it is likely you have missed a required question.

**Please also review the New Study Application tutorial below.

Do I complete the questions with regard to the current status of my study?

No. Complete the new questions as though you were integrating the original Protocol/Research Summary into the electronic application. If your study is currently in data analysis, do not update all of the questions to reflect the current status of the study. Answer the questions as you would have if the study were new and just being submitted.

If you are submitting an Amendment with your Continuing Review or by itself, you should update sections directly related to the changes proposed by the Amendment. However, it is strongly recommended that no amendments be submitted with your Summary integration Continuing Review. The staff has a very difficult time distinguishing changes proposed by the amendment with additions related to the integration. If you can possibly wait to submit amendments separately, please do so.

I need to update an existing waiver request. What do I do?

Click the “Update” button next to the existing waiver on the “Waiver” page. If your originally approved application included a waiver, the existing waiver page should be edited/updated; a new waiver should NOT be added. DO NOT use the “Add” button to submit a new waiver unless you are also submitting an Amendment to add a new waiver request. If you accidentally add another waiver, please contact the IRB at 801-581-3655 to have it deleted from your study application.

I need to submit an amendment. Should I complete the integration questions at the same time?

It is not recommended. The staff has a very difficult time distinguishing changes proposed by the amendment with additions related to the integration. If you can possibly wait to complete the integration at continuing review, please do so. If you are submitting an Amendment, you should update sections directly related to the changes proposed by the Amendment. Use the “Jump To” menu to navigate the pages rather than the “Continue” button, which will force you to complete all of the sections.

Also, study teams are not providing enough information in amendment applications about the changes they wish to make. You must provide the IRB with a detailed response regarding the following items:

  1. What are you changing?
  2. Why are you making this change?
  3. Where are these changes reflected in your application (Update Study) and your study documents?

It is helpful if you make a list of all of the changes, grouping changes that go together (i.e., administrative changes, risk changes, procedure changes, consent changes, etc.), and then make sure the questions above are answered for each change. Provide this list in the amendment application.

Also at amendment, the IRB will still accept a tracked copy of the protocol summary if you attach it under “Other Documents”. This will help you to communicate the changes to the IRB as well as help the IRB conduct an efficient review.

Tutorials

The IRB Staff has created several tutorials to help study teams navigate the new changes in the application.

Tutorial Description Version
Approval Letter Determinations [PDF] This document includes descriptions of the determinations the IRB routinely includes in its approval letters, and what each determination means. 01.2012
Full Protocol Requirements [PDF] This document will help you decide whether you need to attach a full protocol to your IRB application. 01.2012
Help Text Index This document contains a read-only list of all the blue help text in ERICA. Coming Soon
New Study Application [PDF] The New Study Application was revised in 2012 to comply with updated policies and procedures, to enhance understanding and readability of the questions, and to eliminate unnecessary duplication. This tutorial is intended to provide you with more in-depth and practical assistance as you complete your New Study Application.

This tutorial can also be used to help you as you complete the Update Study Application at continuing review.
01.2012
Protocol Summary e-Version [PDF] This tutorial includes instructions for generating a traditional protocol summary from the answers provided in your application. 01.2012
Summary of Changes [PDF] The IRB has compiled a summary of the changes for the ERICA update. 01.2012
View Differences Tutorial [PDF] This tutorial will show you how to view tracked changes to the New Study or Update Study application using the “View Differences” button. 01.2012

Check out our Tutorials page to see what else is available!

RATS Classes

The Research Administration Training Series (RATS) class titled “Understanding IRB Applications in ERICA” is taught each semester. Beginning in 2012, this class will present the new questions in the IRB application. To register for this class, please visit the RATS website, https://education.research.utah.edu.