Submission Guides

Below you will find checklists that take you through the lifecycle of a currently-approved study, as well as important links that will aid you in submitting your study.

Complete the following steps to submit your new study


 

Before you begin, please note that all investigators and research staff must complete the required education courses, gain access to the InfoEd eRa website, and complete several other tasks. These tasks can take several days to complete, so please factor that into your planning.

1

Determine if you need to submit for institutional approval

COMIRB's affiliated institutions each require investigators to submit for institutional approval prior to submitting to COMIRB. Please contact the appropriate institutional research office for each of the following sites involved with your research: 

  • CU Denver Anschutz Medical Campus, University of Colorado Hospital, Children’s Hospital Colorado, or Highlands Ranch Hospital: Your research may need to be submitted through the Human Subject Research portal to gain institutional approval.
  • Denver Health and Hospital Authority: Contact the SPARO Office at sparo@dhha.org
  • University of Colorado Cancer Center: Your research may need to be submitted to PRMS before COMIRB review.
  • Denver VA Medical Center: Contact the Research Administrative Office at 303-399-8020 ext. 2755 
  • CU Denver Downtown Campus: Research conducted solely on the Downtown Denver Campus does not require any institutional approval in addition to COMIRB review. However, COMIRB review is still required.

3

Compile supporting documents

Documents should be labeled with the PI's name, page numbers, the protocol number (assigned during the electronic submission process), and version date. COMIRB electronically stamps consent documents and local advertisements in the top right-hand corner which covers any content in that area. Please do not place content in the top right-hand corner of these documents.

4

Submit the materials to COMIRB via the InfoEd eRA website

First-time users are encouraged to attend our Beginner's Guide to InfoEd eRa course (CTSA33); View the calendar of available courses.

To obtain a COMIRB number (21-XXXX) and create a new protocol submission: select the Denver campus from the InfoEd eRA login page. Then, click Human Protocol, and Create New Human Protocol. 

 

For help with your submission or the submission process, please contact our help desk at comirb@ucdenver.edu

Complete the following steps to submit your study amendment



1

Create new study documents and/or revise existing study documents

Your amendment may involve adding new documents, like a new advertisement or survey. Your amendment may involve revising existing study documents to reflect the change you are making. Keep in mind that information relevant to your change may affect multiple documents. For instance, adding a new survey to your study will likely require revisions to your protocol and perhaps your application form and consent form.

If you are making changes to documents that were previously submitted to and approved by COMIRB, it is necessary to upload 2 copies of the revised version of each document you are amending. One copy of the revised document should be a marked-up version using Microsoft Office’s “track-changes” feature to show changes made, and the second document should be the clean (no markup) version for stamping. If the “track-changes” feature is not available, please submit a highlighted (in yellow or green) version, or provide a detailed list of changes. Important note: it is not possible to track changes or highlight the smart PDF version of the Application for Protocol Review Form.​

2

Include necessary information

Include a cover letter that tells us about your amendment. What is the purpose of the amendment? What is the rationale for the amendment?

3

Complete the Change Form

Please be detailed about the study changes (including personnel changes).

Complete the following steps to submit your study for Continuing Review


 

If you plan to request any changes to your study (including personnel changes) in addition to requesting Continuing Review of your study, you must submit those change requests in an Amendment submission separate from your Continuing Review. That is, you will be making two separate submissions to COMIRB via the InfoEd eRa website: a Continuing Review submission to request that your study be authorized for another year, and an Amendment submission to request the changes to your study.

1

Check required training

If any study personnel need to renew their CITI training, please ask them to do so. This will prevent delays in renewing your approval.

2

Check annual Conflict of Interest Disclosures

Make sure that your study personnel have completed their annual COI disclosure. This will prevent delays in renewing your approval.

3

Review COMIRB requests from the previous year

Review COMIRB approval letters over the past year and make sure you have responded to any requests for changes.

6

Submit the materials to the COMIRB via the InfoEd eRa

Complete the following steps to submit your Unanticipated Problem Report



1

Complete the Unanticipated Problem Report (UAP) Form

2

Compile all supporting documents relevant to Unanticipated Problem Report

For example, Audit Reports, DSMB Reports, Safety Reports, Sponsor Letters.

3

Submit the materials to the COMIRB via the InfoEd eRa website

Exempt Studies



If you would like to close an open Exempt study, please email your request to COMIRB@ucdenver.edu​. In the email identify the Principal Investigator and the COMIRB protocol number.


Full Board and Expedited Studies



To close a study, make a Study Closure submission in InfoEd eRA. Attach a cover letter which explains why you would like to close the study. Attach Continuing Review Form.

To re-open a study that was previously closed, make a Continuing Review submission in InfoEd eRA. If the study has been closed or expired for more than two years, please contact COMIRB at COMIRB@ucdenver.edu or 303-724-1055.