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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: All CTRC and CHCO protocols are required to be submitted through the HSR Portal.  Full Board and expedited UCD, DHHA, UCHealth and CU Medicine Clinic studies are required to be submitted to the HSR Portal. ​ ​

Please note: the COMIRB is in the process of updating its application forms to reflect these instructions.​

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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
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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. If you do not have the documents the system is asking for and they are not applicable, please upload a document stating such. You have the option to save and return later if you start the form and determine additional documents are needed to complete the application.  

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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.

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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