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Protocol/Research Summary Forms

Published on:

January 11, 2012

The IRB recently announced that the information collected in the Protocol/Research Summary forms is being integrated into the ERICA new study application.

Because of this change, the ERICA system will be offline starting Friday, 1/13 at 5:00 PM until Tuesday, 1/17. Beginning 1/17/2012, the new version of the application will be in use and the Protocol/Research Summary will no longer be required.

Please consider the following in preparation for this change.

New Study Application

  • New studies submitted after 1/17 will require the new version of the application. ERICA will not allow you to submit the application to the IRB until the new questions are completed.
  • New studies submitted before 1/13 that are still in process will be required to complete all of the new questions IF the application is sent back to the study team for revisions at any time. This includes revisions from the IRB and any ancillary committee review that may be required.
    • If all of your new study revisions are completed before 1/13, you will not be required to complete the new questions until your next continuing review application.

PLEASE NOTE: Submitting your new study application before 1/13 does not guarantee that you will avoid the requirement to complete the new questions. If revisions are requested for your study after 1/17, the new questions are required.

Continuing Review Applications

Please submit continuing review applications early to prevent expiration. Note that while the time needed to complete the application will be greater than normal, the IRB review times will remain unaffected so long as the volume of applications is normal.

  • Continuing review applications submitted after 1/17 will be required to complete the new questions in the Update Study Application. ERICA will not allow you to submit a continuing review application to the IRB until the new questions are completed.
  • Continuing review applications submitted before 1/13 that are still in process will be required to complete all of the new questions IF the continuing review application is sent back to the study team for revisions at any time. This includes revisions from the IRB and any ancillary committee review that may be required.
    • If all of your continuing review revisions are completed before 1/13, you will not be required to complete the new questions until your next continuing review application.

PLEASE NOTE: Submitting your continuing review application before 1/13 does not guarantee that you will avoid the requirement to complete the new questions. If revisions are requested for your study after 1/17, the new questions are required.

Amendment Application

  • The new questions in the Update Study Application are not required on amendment applications. ERICA will allow you to submit an amendment application while leaving the new questions blank.
  • If you need to make changes to the Update Study Application as part of your amendment, save the changes you make and then use the “Jump-To” menu to move between pages. If you use the “Continue” button, ERICA will ask you to fill in the other blank questions.
  • You may choose to complete the new questions in the Update Study Application as part of your amendment, instead of waiting until continuing review.

Final Project Reports

  • The new questions in the Update Study Application are not required on final project reports. ERICA will allow you to submit a final project report while leaving the new questions blank.

Report Forms

This update does not affect the submission of report forms.

Full Protocol vs Protocol Summary

There are some studies that will still require a full protocol to be attached to the ERICA application, as follows:

  • Industry sponsored studies where a company protocol is provided by the sponsor.
  • Investigator-initiated investigational drug and device trials where the local PI holds the IND or IDE for the investigation.

There may be other instances where you maintain or are provided with a full protocol. These may be attached in ERICA for additional information, however, it is not required except in the two cases mentioned above or unless requested specifically.

e-Protocol/Research Summary

ERICA will maintain a read-only copy of your most recently approved protocol/research summary. This will be accessible to you via the Documents page in ERICA.

ERICA will also maintain an up-to-date e-version of a protocol summary. This e-version is different than the protocol/research summary template used prior to 1/17/2012. This e-version will compile information you provide in your application into a summary view and will include the following sections:

  • A title page, with study title, investigator names, IRB approval date, and IRB number
  • Background and Introduction
  • Purpose and Objectives
  • Study Population description, with age of participant and inclusion/exclusion criteria
  • Design
  • Study Procedures description, including recruitment, informed consent process, and procedures conducted with participants/data
  • Statistical Methods, Data Analysis and Interpretation

This will also be accessible to you via the Documents page in ERICA.

Education Opportunities

The IRB is offering several opportunities to learn about the changes, familiarize yourself with the new ERICA application questions, and gain hands-on experience with the new application. Attached are the opportunities that are offered [PDF]. Space is limited for each session, so RSVP soon. If you have any questions, please contact Annie Snow at annie.snow@hsc.utah.edu.

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