Human Subjects Research Protocol Submission Portal

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:

Portal guidance screenshot

 

Sites:

When adding sites, only include sites where recruitment/patient interaction is involved:

HSR Portal Guidance screenshot

For a retrospective study pulling data from Epic, only choose the UCHealth site(s) where the study team physically exists.

HSR Portal screenshot

 

Patient Interaction:

If you anticipate any invasive and/or billable procedures at any of the hospitals, please select yes to patient interaction.

HSR Portal screenshot

 

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:

HSR Portal Screenshot

 

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:

HSR Portal Screenshot

 

Staff Section

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.

HSR Portal screenshot

 

Calendar Section

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:

HSR Portal screenshot

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:

HSR Portal screenshot

 

Supporting Documents Section

For supporting docs, please note that only the fields with *must provide value are required to be uploaded:

HSR Portal Screenshot

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.

HSR Portal Guidance

HSR Portal Screenshot

 

CHCO studies:

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!

 

Return codes:

You can finish your submission later on if you are not ready by clicking Save & Return Later at the bottom of the submission page:

HSR Portal screenshot

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 (oncoresupport@ucdenver.edu).

 

Returning to your portal submission:

Using the return code and link, you will be given two options after you click the link:

  • Submit a return code
  • Start over

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.

HSR Portal screenshot

 

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:

HSR Protocol screenshot

 

Oncology:

If any cancer population is included on study, please select yes to cancer related questions:

HSR Portal screenshot

 

Funding Section: CTRC

For microgrants, please select microgrant under funding:

HSR Screenshot

There is also an additional question in this section pertaining to microgrants that need to be selected as yes:

HSR Portal screenshot

 

Site selection for CTRC usage:

Also, please select UCH as a site if you are utilizing the CTRC at UCH.

HSR Portal screenshot

If you are using CHCO CTRC, please select yes to this question in the site selection section:

HSR Portal screenshot

 

CTRC services:

You must also fill out the CTRC section for services you intend to use:

HSR Portal Screenshot

 

UCH Services:

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:

HSR Portal screenshot

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.

HSR Portal screenshot