Step 2: What information is required to submit?
The follwing three items are requried for all submissions:
- IRB (COMIRB) Tracking Number
- COMIRB Personnel Page from InfoEd
(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:
Draft budget proposal
Draft Purchasing Service Agreement
Investigational Product Management Plan
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.
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
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.