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. If using CTRC services, you’ll need: 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 Letter.
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.**
Study Information Section
Please ensure that your COMIRB number is accurate:
When adding sites, only include sites where recruitment/patient interaction is involved:
For a retrospective study pulling data from Epic, only choose the UCHealth site(s) where the study team physically exists.
If you anticipate any invasive and/or billable procedures at any of the hospitals, please select yes to patient interaction.
Please choose correct department and division for PI. SOM-Medicine or SOM-Pediatrics are the two most commonly used departments if you are unsure. You can also choose other, but please review entire dropdown list first:
IRB of Record Section
For COMIRB studies, only choose exempt if you anticipate exempt review from COMIRB. Please review the “is your study limited to the following area(s) section. This indicates whether or not this will go to COMIRB expedited or COMIRB full board:
When entering staff, please note we only need local UCD, DH, CHCO and/or UCH staff. Do not enter collaborators at institutions other than these. Additionally, please do not select “Other” as a department.
Please ensure that the primary contact listed in staff section will be doing the calendar signoff. If not, please indicate in the Calendar Build section:
Please note that a calendar will be required for any study that has invasive/billable procedures.
Feasibility/Recruitment Plan Section
Accrual numbers should line up. If a multi-site trial, Total Protocol Enrollment should be larger than local protocol enrollment. Typically, anticipated number of consented subjects is also larger than local protocol enrollment, or the same number:
Supporting Documents Section
For supporting docs, please note that only the fields with *must provide value are required to be uploaded:
The others are optional.
Submission: Final Steps
When you submit, please enter an email on the following page after submission so that you receive your portal clearance.
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).
Returning to your portal submission:
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.
Will your study include UCD clinics/centers? If so, select “Other Clinics/Centers managed by UCD” to open the UCD AMC list where you can indicate the specific sites.
If you are using the Comprehensive Women’s Health Center, CU Advanced Reproductive Medicine, Parker Perinatal Center or Platte River Perinatal Center sites, please select free-standing Clinics as indicated below:
If any cancer population is included on study, please select yes to cancer related questions:
Funding Section: CTRC
For microgrants, please select microgrant under funding:
There is also an additional question in this section pertaining to microgrants that need to be selected as yes:
Site selection for CTRC usage:
Also, please select UCH as a site if you are utilizing the CTRC at UCH.
If you are using CHCO CTRC, please select yes to this question in the site selection section:
You must also fill out the CTRC section for services you intend to use:
If you plan to use the CTRC in addition to UCH services, please select no to the following question and fill out the UCH services you intend to use:
Please select yes if you only intend to use UCH for CTRC services on the first question above and select all UCH services as no.
Investigational Item or Service
Please ensure these questions are answered per the protocol. When applicable, further information on investigational drugs (i.e., IND number) and devices (i.e., IDE number) may be requested. If your team is also planning on managing/storing drugs and/or devices yourself, we need this indicated in these questions.