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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 triages studies to the appropriate individuals, groups, departments, etc. involved directly or indirectly with the operations of the study.
  
 

Submission Instructions

Step 1:  Use the Below Decision Tool to Determine Whether Portal Submission is Required.


Select all sites where visits, data gathering or other study interactions occur; then select the type of review you are requesting. Click the "Does your protocol use the Portal?" button to find out whether or not a Portal submission is required.
 
The Portal is only used for new submissions or when you are adding a research site to your protocol.
 

Step 2:  The following three items are required for all submissions:

  
  1. IRB (COMIRB) Tracking Number
  2. COMIRB Personnel Page from InfoEd
  3. Protocol (The COMIRB application for protocol review can be substituted for NHSR/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
 

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:  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.

Adding a research site to an already approved protocol?
 
Please enter your IRB (COMIRB) Tracking Number in the following format:
 
xx-xxxxamd[date of submission], e.g., 17-9999amd05.15.17
 
All other amendments should be submitted to the Amendment Portal.
 
 
 

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

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