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CReST Help Request Form

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The Clinical Research Support Team (CReST) assigns study coordinators to assist CU investigators with their research operations under a customizable fee-for-service model. Our team of fully onboarded and CITI-trained staff can assist with participant recruitment, data entry, visit scheduling and facilitation, regulatory and administrative tasks, and more. This resource allows investigators to get help quickly and pay only for the amount of effort required for as long as needed.

CReST also provides independent Clinical Monitoring to meet FDA requirements and ensure the safety and welfare of participants and the quality of the trial data. Our team of monitors, backed by industry and FDA-regulated IIT experience, can develop Clinical Monitoring Plans, conduct monitoring visits, and provide reports on trial and record quality for the full trial duration, or conduct one-off visits and regulatory trainings by request.

Please fill out the form below to tell us about your project, and we will set up a meeting to discuss how we can help. Most fields are not required, but more information will help us make the best use of your time.

CReST Support Services Cost

Service	Study Type	Cost per hour (effective 7/1/2023 - 6/30/2024)	Cost per hour (effective 7/1/2024 - 6/30/2025)
Clinical Coordination	Investigator-initiated	$68	$72
	Industry-sponsored	$93	$98.50
IRB & Regulatory	Investigator-initiated	$68	$72
	Industry-sponsored	$93	$98.50
Startup & Administration	Investigator-initiated	$68	$72
	Industry-sponsored	$93	$98.50

Clinical Monitoring & EDC Builds	Investigator-initiated	$93	$98.50
	Industry-sponsored	$121	$128.25

DSMB Setup & Facilitation	For pricing estimates, please visit the DSMB page

Please note the following:

Costs can increase on a yearly basis by 6% due to inflation.
Studies spanning for more than one year, budget correctly for steady spending. Prices are subject to change July 1st of every year.
Micro-grants cannot be used to pay for CReST services.
Payment for services will be through iLab to a university speed type.

PI First and Last Name:

* must provide value

PI Department:

PI Email Address:

* must provide value

Primary Contact First and Last Name:

* must provide value

Primary Contact Email Address:

* must provide value

What type of research study do you need help with?

* must provide value

Clinical trial

Observational study

Registry

Retrospective Chart Review

Other

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What is the funding source for this study?

Industry-sponsored

Investigator Initiated

NIH or federal grant

Other

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If other, please specify the type of research study:

* must provide value

Has a CDA/NDA been executed?

* must provide value

What services do you need assistance with? Please select all that apply.

NOTE: **Monitoring rates apply for "Clinical Monitoring" and "eCRF/EDC build" services.

Startup and Administration

IRB and Regulatory

Clinical Coordination

**Clinical Monitoring

Budget creation and/or negotiation

Financial services or invoicing

DSMB

**eCRF/EDC build

IND/IDE application

Other

Note: you have selected a CReST Monitoring service. If you have also selected Admin services (e.g., startup, regulatory, coordination, etc.), the CReST Monitoring Team and the CReST Admin Team will reach out to you separately to discuss your study needs.

We look forward to working with you!

For IND/IDE application services, please also complete the IND-IDE Office (IIO) Triage/Intake form, located on their website.

The IIO provides FDA IND/IDE application development and submission support free of charge.

If other, please specify what services you need assistance with.

Please provide an estimated coordinator time needed for each aspect of the study you are requesting support for?

For example, if you select subject recruitment, data collection, and AE reporting, please provide an estimated amount of time for each of those services.

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Please provide any additional comments or information regarding your study and services needed:

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Do you have a COMIRB number yet?

Yes

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COMIRB protocol number:

What IRB do you plan or have you used for this study?

Many clinical research studies require the services of other entities on CU Anschutz Medical Campus. Please select all locations where research activities for your study will take place:

Outpatient CTRC

Inpatient CTRC

Local CTRC Core Lab

CU Research Pharmacy

UCHealth Pharmacy

Veterans Health Administration

CU Medicine Clinics

Other UCHealth Clinics

Children's Hospital of Colorado (monitoring only)

Other

If other, please specify what location research-related activities will occur:

Has the study already started?

Yes

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What is the anticipated start date?

M-D-Y

What is the anticipated end date?

M-D-Y

What is the expected enrollment target for your site?

What is the approximate budget for this study?

Is this your first-time request CReST assistance?

Yes

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How should we get in touch?

1) My outlook calendar is up to date. Find a time and send me a meeting invite.

2) Email me to set up a time.

3) These are the times that work for me to meet. Send me an invite (please provide at least 3 dates and times.).

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Dates and times I can meet:

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Contract:

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Budget:

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Protocol:

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Informed Consent Form:

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Case Report Forms:

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Questionnaire(s):

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