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Continuing Reviews & HRPP Progress Updates

All studies that are open must provide information to the IRB periodically, according to the following guidelines. 

 

Continuing Review

for re-approval of research

HRPP Progress Update

for studies that do not expire

Applicability

Submit a Continuing Review application if your study has an approval period with an expiration date.

The study's expiration date can be found:

  1. on the most recent IRB approval letter, and
  2. on the workspace of the study in ERICA. 

Submit an annual HRPP Progress Update application for studies without an expiration date. This includes studies with an Exemption determination.

This information about the study can be found:

  1. on IRB's initial determination letter, and
  2. on the workspace of the study in ERICA.

Submission timing & rules for automatic study closure

You will receive two reminders from the ERICA system that the Continuing Review submission is coming due.

Continuing Review applications should be submitted eight weeks before the study expiration date to ensure the study does not expire before renewed approval.

If the Principal Investigator has not completed study enrollment and/or procedures and the study expires, he/she must immediately cease enrollment and all other activities related to the study.

If the study expires before a Continuing Review application is submitted, the study will be administratively closed. If a study is closed before the study is complete, a New Study application must be submitted to the IRB to continue research activities.

The investigator may not continue until he/she has received IRB approval to do so.

You will receive two reminders from the ERICA system that the Annual HRPP Progress Update submission is coming due. 

For studies without an expiration date, investigators do not need to wait for IRB approval of the HRPP Progress Update. The HRPP Progress Update application will be automatically acknowledge by the ERICA system if all training and COI disclosures for study personnel are up-to-date.

If the Principal Investigator does not submit the HRPP Progress Update by the annual anniversary date of the study's initial approval/exemption, the study will be administratively closed. 

If a study is closed before the study is complete, a New Study application must be submitted to the IRB to continue research activities. The investigator must wait until that new application is approved to continue research activities.

Submission requirements

The Continuing Review application must describe the following:

  • progress of the study
  • enrollment and withdrawals
  • adverse events, complaints, and other problems that have occurred
  • safety monitoring results

Investigators applying for continuing approval of a research protocol must submit the following documents in the ERICA update study application along with the completed ERICA continuing review application.

Documents previously approved are retained in the ERICA system and are included in the ERICA continuing review application.

No new forms or documents will be reviewed or approved without an amendment application.

Documents should be attached to the Documents and Attachments page of the update study application or completed in the application as indicated. Templates for documents can be found on the IRB Forms page.

The HRPP Progress Update application must describe the following:

  • progress of the study
  • enrollment and withdrawals

No new forms or documents will be reviewed or approved without an amendment application.

How to add on an Amendment

The Continuing Review application includes the option to add on an Amendment. Fill out the amendment pages and it will be reviewed and approved in combination with the Continuing Review. 

The HRPP Progress Update application includes the option to add on an Amendment. Fill out the Amendment pages as prompted. 

When an amendment is added, the HRPP Progress Update is not automatically acknowledge by the ERICA system. The combined HRPP Progress Update and Amendment application will go through the regular amendment review process. Changes to the study should not be initiated until IRB approval for the amendment is received. 

Fees

For-profit and/or industry sponsored studies and single IRB studies must pay IRB fees before the study will receive renewed approval.

For-profit and/or industry sponsored studies and single IRB studies must pay annual IRB fees, which will be invoiced separately from the HRPP Progress Update application.

Why is this application required?

  1. To allow the IRB to determine if the study can be re-approved based on the Criteria for IRB Approval of Research. 
  2. To document progress and enrollment information for monitoring by the Human Research Protection Program (HRPP).
  1. To ensure training and COI disclosures are complete and up-to-date for study personnel.
  2. To document progress and enrollment information for monitoring by the Human Research Protection Program (HRPP).
  3. To prompt closure of the study if research procedures are complete. 

Submitting a Continuing Review or HRPP Progress Update Application in ERICA

  • Open the study.
  • Click on the Continuing Reviews tab.
  • Click on the Create button.
  • Complete the application entirely. The ERICA application automatically determines which pages of the application you need, based on whether you need a Continuing Review or HRPP Progress Update. 
  • For Continuing Reviews, attach any updated/revised documents to the Update Study application including new consent documents that need to be approved for another year.
  • Submit the application to the IRB for review and processing.
Last Updated: 6/13/22