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University Research

University of Colorado Denver
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Human Subject Research

Protocol Submission Portal


The Human Subject Research (HSR) Portal process will ensure that your human subject research at the University of Colorado Anschutz Medical Campus is ready for IRB submission and has received all necessary approvals for study startup. 
 
 

Benefits for Principal Investigator and Study Team

  • Online submission process
  • Simultaneous reviews by UCHealth, CHCO, CTRC, and scientific review committee
  • Scientific review including biostatistics, if needed*
  • Facilitates faster IRB review because of pre-IRB review
  • Entry point for OnCore

*Scientific Advisory & Review Committee (SARC)--Most Investigator-initiated Full Board studies, which have not received previous scientific review, are required to be reviewed before submission to COMIRB. Deadlines for submission can be found on the SARC website. The Portal administrators will determine if scientific review is necessary after submission using this decision tool.

Submission Instructions

Step 1: Who needs to submit?


Select all sites where visits, data gathering or other study interactions occur, or where staff are employed, and the type of review you are requesting. Then, click the "Does your protocol use the Portal?" button to find out what you need to do.

Step 2: What information is required to submit?

  

The follwing three items are requried for all submissions:

  1. IRB (COMIRB) Tracking Number
  2. COMIRB Personnel Page from InfoEd
  3. Protocol (The COMIRB application for protocol review is acceptable for NHSR and Exempt studies)
 

Depending on your research sites, sponsor, and type of IRB review (e.g., Full Board vs Expedited), the following documents may also be required:

  1. Draft contract
  2. Draft budget proposal
  3. Draft consent/assent
  4. Calendar of Events Template or equivalent if already developed
  5. Draft Purchasing Service Agreement
  6. Investigational Product Management Plan
  7. IRB Authorization/Reliance Agreement (for IRB ceding requests)
 

As you complete the Clinical Research Administration Protocol Assessment Form, a list of documents required for your submission will populate at the bottom of the form. You will not be able to submit unless you have uploaded all of the required documents to the application. You have the option to save and return later if you start the form and determine additional documents are needed to complete the application.   

 

Step 3: Submit to the HSR Portal

 

Complete the Clinical Research Administration Protocol Assessment Form and upload your required documents via the link below.  

IMPORTANT: You will be prompted to enter an email address to receive the submission confirmation or Portal clearance email, as applicable. Please make sure to check your Inbox and save this email as Clinical Research Administration will not be copied.

 
 

If you have any questions about the submission process, please contact the Clinical Research Support Center at ClinicalResearchSupportCenter@UCDenver.edu.

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