CHCO Protocols: All CHCO protocols must be submitted through the HSR portal.
DHHA Protocols: Denver Health only studies that are Clinical Trials, Full Board Review, and/or requests to cede review to an external IRB must be submitted to the HSR Portal. Studies that involve Denver Health and any other site must be submitted based on the requirements for CHCO, UCD and/or UCHealth.
UCD Protocols: UCD only studies that require full board or expedited review, that are funded, or that involve a request to rely on an external IRB must be submitted to the HSR Portal. When funded, draft agreements or other funding information is required to be included. Unfunded studies that might meet the definition of exempt or secondary research, do not require submission through the HSR Portal.
UCHealth and CU Medicine Clinic Protocols: The following human subjects research projects must be submitted through the HSR Portal: Exempt studies with outside funding, studies that are minimal risk (expedited review) and studies that are more than minimal risk (full board).
VA Protocols: VA studies need to be submitted if they involve another of our sites or if they are funded through the University.
External IRB Requests: Any requests to use an External IRB must be submitted to the HSR Portal with protocol, draft consent, and draft calendar of events.
Submitting Amendments through the Portal
This submission process manages amendment submissions that impact Oncore and the study’s calendar and information in Oncore.
The following changes must be submitted through the Portal:
Change to PI
Changes to budget
Changes to calendar
Changes to MCA
New arm/new procedures
Correction to calendar/financials
CTRC resource requests and/or requesting a microgrant
You are not obligated to submit changes related to study staff, consent forms, or other (non-protocol) study related documents.
Submissions to the Portal are processed as received and anything requiring updates in OnCore is placed in the queue and assigned by date received.
Changes to PI, budget, or contract terms will require a contract amendment. Use the link below to provide a Word version of the contract amendment to CRAO.
FDA’s Single Patient IND/IDE Pathway allows use of an investigational drug, biologic, or device to treat a patient who:
Is suffering from a serious or immediately life-threatening disease or condition, and
Does not have comparable satisfactory alternative therapies, and
Cannot participate in a clinical trial.
If the risks associated with treatment are not unreasonable, and potential benefit justifies potential risks.
We can help treating physicians navigate this pathway for their patients who meet these criteria. We will facilitate the FDA application process, IRB Chair Review request, and institutional reviews. However, the treating physician will be the IND/IDE holder, and must comply with all regulatory, institutional, and manufacturer requirements in order to treat a patient under a single patient IND/IDE.
The Investigational Product Review Committee (IPRC) conducts reviews of human subject research protocols to be conducted by a University of Colorado, Denver (UCD) faculty member if this faculty member plans to take responsibility for one or more of the following activities in relation to the investigational product: design, development, production, storage, management, compounding and/or dispensing of any investigational product. This committee does not review management of investigational product management under the control of the affiliate hospital, hospital pharmacy or the Skaggs School of Pharmacy and Pharmaceutical Sciences (SSPPS).
The IPRC reviews these studies to assure there is an appropriate plan in place that addresses acceptable design, development, and production processes, compounding standards, relevant regulations compliance and other State and local requirements.
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.
**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!
can finish your submission later on if you are not ready by clicking
Save & Return Later at the bottom of the submission page:
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 (email@example.com).
Using the return code and link, you will be given two options after you click the link:
Submit a return code
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.
Study Information Section
Please ensure that your COMIRB number is accurate:
Study Information Section: Sites
When adding sites, only include sites where recruitment/patient interaction is involved:
Sites: Retrospective Studies
For a retrospective study pulling data from Epic, only choose the UCHealth site(s) where the study team physically exists.
Study Information Section: Patient Interaction
If you anticipate any invasive and/or billable procedures at any of the hospitals, please select yes to patient interaction.
Study Information Section: Department
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.
Need more specific guidance?
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.
Selecting Sites: Free-standing Clinics
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.
After you submit to the Amendment Portal, Clinical Research Administration and OnCore Support teams review the changes for regulatory and billing compliance implications.