Before you start, you will need:
1. IRB (COMIRB) Tracking Number
2. Protocol Template
3. If industry funded/industry initiated, you’ll also need: Draft contract
4. Draft Calendar of Events
5. You’ll be able to include other optional documents to help us review your study.
IMPORTANT: COMIRB requires a Portal Clearance Memo with your submission for initial review of non-exempt research.
Enter your email address when prompted, and you’ll receive this email from ClinicalResearchSupportCenter@ucdenver.edu once the review is complete.
**Please make sure to check your Inbox and save this email as Clinical Research Administration will not be copied.**
For Children’s studies, you must complete the CHCO ancillary form, in addition to the screen you enter your email for portal clearance.
Also note that if your study is investigator initiated, locally written with no previous scientific review, it will need either PRMS (if oncology) or SARC (all other non-cancer studies) review to receive portal clearance. You will be emailed along with the PI by either SARC or PRMS for this review.
Need to save and come back to your submission?
You have the option to save and return later if you start the form and need to some back. Just write down your return code!
You can finish your submission later on if you are not ready by clicking Save & Return Later at the bottom of the submission page:
This will provide a return link and code. Please only use this if you have not fully submitted your portal form. If you need to return and make corrections to an already submitted study, please request the code and link from OnCore Support (firstname.lastname@example.org).
Using the return code and link, you will be given two options after you click the link:
If the “start over” button is selected, it will remove all responses from the form. Please use the option only when you need to delete every entry from your portal survey.
After you submit to the Amendment Portal, Clinical Research Administration and OnCore Support teams review the changes for regulatory and billing compliance implications.