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University Research

University of Colorado Denver
 

Human Subject Research

Protocol Submission Portal


The Research Submission Portal process will ensure that your human subject research at the University of Colorado Anschutz Medical Campus is ready for IRB submission. This portal is designed for researchers and study teams to submit their human subject research for review by the University of Colorado Hospital, Children's Hospital Colorado, Clinical and Translational Research Center (CTRC), and University of Colorado.

Benefits for Principal Investigator and Study Team

  • Online submission process
  • Simultaneous reviews by CTRC, hospital(s), and scientific review committee
  • Scientific review including biostatistics, if needed*
  • Consolidated feedback for Principal Investigator from all reviewers
  • Facilitates faster IRB review because of pre-IRB review

*Most Investigator Initiated Full Board studies, which have not recieved previous scientific review, are required to be reviewed before submission to COMIRB.  Deadlines for submission can be found here.  The portal administrators will determine if scientific review is necessary after submission using this decision tool.

Submission Instructions

Step 1: Does your research need to be submitted?

Select all sites where visits, recruitment, or data gathering occur and the type of review you are requesting to determine if you need to use the protocol submission portal. Then, click the "Does your protocol use the Portal?" button to find out what you need to do. **Please use this tool in Internet Explorer**  If you are requesting pricing information from UCHealth follow these instructions.  Any protocol requeting CTRC services must be submitted through the portal for feasibility and/or Scientific review regardless of review type.

The portal is used for initial submissions or addition of a new site to already approved research.  Please do not submit amendments through the portal.

Step 2: What will you need to submit your research?

Depending on the locations and review type you may be required to submit the documents listed below.  Please use this table to determine which documents are required for your submission.  For UCHealth pricing only requests use these instructions.

  1. To Log Into the system you will need a CU Denver username or Person of Interest Number
  2. IRB (COMIRB) Tracking Number
  3. Protocol (The COMIRB application for protocol review is acceptable for NHSR and Exempt studies)
  4. Protocol Assessment Form DOWNLOAD this form, do not complete in browser (and other related documents as requested)
    • Studies that involve the University of Colorado Hospital in any way (subject visits, recruitment, chart review, etc.) must complete the UCHealth Research Support Services Application in addition to a HSR Portal submission.  The link to this application can be found in the Protocol Assessment Form and the application instructions can be found here.
  5. Calendar of Events Template or equivalent if already developed
    (must have research and standard of care procedures identified)
    • Calendar of Events is NOT REQUIRED If project uses ONLY existing medical records, existing samples, or survey data
  6. COMIRB Personnel Page from InfoEd
  7. Industry funded studies at UCHealth: Contract, Contractual budget and consent (draft acceptable for each)

Important: All documents must be uploaded at the same time. Once you leave the Portal, re-entry to the same submission is not possible.

Step 3: Are you ready to submit?

Once you determine that you need to submit your research through this portal and have all required information and forms completed you are ready to submit your research.

  • To log in use "University\username", "UCH\username" or "Childrens\username" (depending on where you are employed) as your User Name
    NOTE: If you are not within the university campus network (connecting from off campus or from Guest wireless) you may need to connect with the Virtual Private Network (VPN). Contact the CU Denver ITS Help Desk at 303-724-4357 for VPN questions.

If you have any issues gaining access to the portal or have questions about the submission process please contact the Clinical Research Support Center at ClinicalResearchSupportCenter@UCDenver.edu.

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