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Consultation Request

Tell us about your project!

Please select the most appropriate choice for your project:(Required)

Acute Illness and Perioperative Care

Aging

Immunometabolic & Genetic Disease

Infectious Disease

Neurosciences

Cancer

Other

What is your Project's Short Title?:(Required)

Required

What type of Funding Source is under consideration?:(Required)

Industry

Federal

Foundation

Other University / Institution

Investigator Self-Funded (e.g., discretionary; start-up funds)

Internally Funded (e.g., pilot)

I do not yet have this information available

Other

What type of Trial or Requested Billable/IDS Service best describes your submission?:(Required)

Sponsor-Initiated, Single-Site Clinical Trial

Sponsor-Initiated, Multi-Site Clinical Trial

Investigator-Initiated Clinical Trial, Sponsored

Investigator-Initiated Clinical Trial, Self Funded or Internally Funded

Institutional Drug Service Only

Required EPIC Billable

What type of Protocol are you submitting?:(Required)

Diagnostic - Clinical trials directly testing the efficacy of devices, techniques, procedures; or tests for earlier or more accurate detection or diagnosis of disease

Treatment - Clinical trials with therapeutic intent using drugs, radiation, surgery, other biological agents, or behavioral or other interventions

I do not yet have this information available

Other

What Trial Phase is your submission in?:(Required)

Phase 0 - Exploratory study to determine whether an agent behaves in humans as pre-clinical testing indicated

Phase I - Evaluate safety, dose range, and identify side effects in healthy volunteers or in patients with the disease of interest

Phase I/II - Safety, dosage levels, and efficacy of new treatment; device pilot study

Phase II - Evaluate safety and efficacy of selected dosage levels and duration of treatment

Phase II/III - Larger study to confirm safety and efficacy of selected dose(s) and duration of treatment

Phase III - Larger, controlled trial to confirm efficacy compared to a standard treatment regimen or to no treatment; device pivotal study

Phase IV - Post-market study to provide additional information on risks, benefits, and optimal use

I do not yet have this information available

Other

IRB, UFIRST and OCR Information

IRB Coordinator:(Required)

Please enter N/A if you do NOT have an IRB Coordinator

IRB # :(Required)

Please enter N/A if you do NOT have an IRB#

UFIRST Proposal/Agreement Number (if already in UFIRST):(Required)

Please enter N/A if you do NOT have an IRB#. (Example: PRO0001234/AGR0001234)

OCR # :(Required)

Please enter N/A if you do NOT have an IRB#

Upload Document and Add Comments

Please attach Draft Agreements, Protocol, ICF, Budget, Drug/Device Table, PCR Forms, Sponsor Instructions/Correspondence, etc.

Document Upload

Drop files here or

Max. file size: 125 MB.

Comments

Please provide additional instructions or information that can assist us in supporting you.

Tell us about your Principal Investigator / Study Coordinator!

Is this a multiple Principal Investigator trial?:(Required)

Yes

Principal Investigator:(Required)

First Last

Primary Investigator's email address:(Required)

Primary Investigator's phone number:(Required)

Primary Investigator's academic rank:(Required)

Primary Investigator's department or division:(Required)

Study Coordinator Information

If you answered yes to having multiple Principal Investigators, please provide the Study Coordinator Contact below. If your project does NOT have multiple Principal Investigators, please scroll up on this form and correct your answer selection.

Study Coordinator:(Required)

First Last

Study Coordinator's email address:(Required)

Study Coordinator's phone number:(Required)

Form Submitter information:

Please ensure this information is filled out appropriately should the CRH Intake Team have questions regarding your submission.

Are you the PI/Study Coordinator for the study you are submitting?(Required)

Yes, I am the PI and I am submitting this form

Yes, I am the Study Coordinator and I am submitting this form

No, I am neither the PI or the Study Coordinator

Submitting this form on behalf of the PI/Study Coordinator? Please provide your contact information below:

If you answered that you are NOT the Principal Investigator or the Study Coordinator for this submission, please provide your contact below. If you ARE the Principal Investigator / Study Coordinator, please scroll up and correct your answer selection.

Form Submitter (NOT PI/SC):(Required)

First Name Last Name

Form Submitter (NOT PI/SC) Email Address:(Required)

Form Submitter (NOT PI/SC) Phone Number:(Required)

Ready to Submit?:

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What type of Trial or Requested Billable/IDS Service best describes your submission?:(Required)

Sponsor-Initiated, Single-Site Clinical Trial

Sponsor-Initiated, Multi-Site Clinical Trial

Investigator-Initiated Clinical Trial, Sponsored

Investigator-Initiated Clinical Trial, Self Funded or Internally Funded

Institutional Drug Service Only

Required EPIC Billable

Other

Hidden

File Upload

Please attach Draft Agreements, Protocol, Sponsor Instructions/Correspondence, etc.

Drop files here or

Max. file size: 125 MB.

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Please share any important project deadlines:

Does your project have a specific deadline you are trying to meet?

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If yes, Study Team Contact Information:

First Last

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Upload additional files

Max. file size: 125 MB.

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Phone

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File(Required)

**IRB# if applicable at this time** Please attach Draft Agreements, Protocol, Sponsor Instructions/Correspondence, etc.

Max. file size: 125 MB.

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Are you the Study Coordinator?:(Required)

Yes

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Number

This field is for validation purposes and should be left unchanged.