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Required format:

Request for protocol build

Returning?

A A A

Please complete the fields below to request a calendar to be built in OnCore

Thank you!

This form should only be used for two types of studies:

Studies that are already open to accrual, enrolling subjects, have CHCO billable procedures and need to move the protocol into OnCore.

Protocol Amendments should be submitted through the amendment portal which can also initiate a new build in OnCore. All new research studies should be submitted through the Human Subject Research Portal (ucdenver.edu/hsrportal).

Local IRB Protocol Number (COMIRB or UCHealth IRB)

**UCHealth IRB numbers prior to 1/1/2015, please add the prefix UCH##-####)

* must provide value

Protocol Version number and/or date:

E-mail address of person submitting this request

* must provide value

PI Name

* must provide value

PI Department

* must provide value

PI Division

* must provide value

Check all sites where visits, recruitment or study interactions occur.

* must provide value

UCHealth (includes University of Colorado Hospital)

Children's Hospital Colorado

Denver Health

National Jewish Health

Saint Joseph Hospital

University of Colorado Boulder

Veteran's Administration Hospital

Other Clinics/Centers on the Anschutz Medical Campus

Other Sites not on the Anschutz Medical Campus

Does this study utilize CTRC services (including CTRC space)?

* must provide value

Yes

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Specific UCHealth location

* must provide value

UCHealth Northern Colorado

UCHealth Denver Metro

UCHealth Colorado Springs

Specific CTRC location

* must provide value

CHCO

UCHealth

National Jewish

UC Boulder

Perinatal

Investigator or Industry Initiated Protocol?

* must provide value

Select Protocol Type

* must provide value

Does this study evaluate a cancer-related question or population on the Anschutz Medical Campus (including CHCO or UCHealth Metro Denver), or utilize University of Colorado Cancer Center support?

* must provide value

Yes

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Estimated Accrual Duration (months)

* must provide value

Local Protocol Enrollment (on study)

* must provide value

Anticipated number of consented subjects

* must provide value

Total Protocol Enrollment

* must provide value

Is this project being performed at Children's Hospital Colorado only?

* must provide value

Yes

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Does the study utilize the CTRC?

Yes

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Studies listed in OnCore will also appear on a public recruiting site. Who is the primary contact for recruitment for this protocol (email address and phone number)?

* must provide value

Expand

How many subjects are currently on study?

* must provide value

Is the study open to enrollment?

* must provide value

Yes

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Please describe what part of the study subjects are currently in. If the entire protocol calendar is not needed the OnCore calendar builders will only build the part of the calendar that is still needed. For example: 3 subjects are finishing treatment and 10 are on followup.

If the protocol is closed to accrual are there billable services and which arms need to be built?

* must provide value

Expand

Will this study have research subject visits in a CHCO facility after December 2019?
OR
Is the submission being requested by UCHealth Research Administration for integration requirements?

* must provide value

Yes

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Overview of Calendar and Financial Specification Signoff process

Who will do the calendar review? (enter email address)

* must provide value

Is this person also the contact for calendar building questions?

* must provide value

Yes

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Who should be contacted with calendar related questions? (enter email address)

Who will do the Pre-Award Signoff? (enter email address)

* must provide value

Is this person also the contact for financial questions?

* must provide value

Yes

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Who should be contacted with financial questions? (enter email address)

Who will do the Research Manager Signoff? (enter email address)

* must provide value

Is this person also the contact for protocol related questions?

* must provide value

Yes

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Who should be contacted with protocol related questions? (enter email address)

Protocol Information Signoff Process

Who will do the Regulatory Admin Signoff? (enter email address)

* must provide value

Does this study have multiple sponsors?

* must provide value

Yes

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Who is the primary sponsor or who provides funding for the research activities?

If study is unfunded please enter the department that provides salary support for staff involved in the study.

* must provide value

Does this protocol use a Contract Research Organization (CRO)?

Yes

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What is the name of the CRO?

Will you be participating in ALL the arms of this study?

* must provide value

Yes

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Please explain in detail which arms are active at our site?

* must provide value

Expand

What would you like for the arms to be named? Please include both a code (max 10 characters) and description.

For example:
Arm Code : Description
Study tx: Group 1- Device Name
Control: Group 2 - Standard of Care Surgery
Escalation: Dose Escalation Phase
Infants: Infants
Mothers: Mothers

* must provide value

Expand

Are all visits captured on the schedule of events?

* must provide value

Please explain which visits are not captured on the schedule of events.

Is the timing of each visit explained in detail including time unit and ranges?

* must provide value

Yes

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Please explain.

Do you plan to use OnCore as the system for tracking procedures on each visit?

* must provide value

Yes

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Does this study have a waiver of documentation of consent?

* must provide value

Yes

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What procedures happen before consent is documented?

Are the contract and budget fully executed?

* must provide value

The OnCore Support Team will build the calendar for this protocol but will not enter financial information until a fully executed contract and budget are received at OnCoreSupport@UCDenver.edu. Please confirm that you will send the fully executed contract to OnCore support when it is received.

* must provide value

I will notify OnCore Support when the contract is fully executed

How should financials appear on an invoice (in the case of industry sponsors) or on an expense report (for other sponsor types)?

* must provide value

On a per procedure basis (all items should appear as individual line items or invoiceable items)

On a per procedure basis (only some line items or procedures are invoiceable)

On a per visit basis (aggregated visit totals or milestones)

Additional Comments:

Expand

Please upload the Protocol

* must provide value

Upload file

Please upload the budget (draft okay but financials will not be fully entered until a fully executed contract and budget are received).

* must provide value

Upload file

Please upload the contract

* must provide value

Upload file

CTRC Budget

* must provide value

Upload file

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