The code block below illustrates how one might use # and // as comments in your logic and calculations.

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The value entered is not a valid Vanderbilt Medical Record Number (i.e. 4- to 9-digit number, excluding leading zeros). Please try again.

The value you provided must be within the suggested range

The value you provided is outside the suggested range

This value is admissible, but you may wish to double check it.

The value entered must be a time value in the following format HH:MM within the range 00:00-23:59 (e.g., 04:32 or 23:19).

This field must be a 5 or 9 digit U.S. ZIP Code (like 94043). Please re-enter it now.

This field must be a 10 digit U.S. phone number (like 415 555 1212). Please re-enter it now.

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The value you provided could not be validated because it does not follow the expected format. Please try again.

Required format:

nQBLIhIUZoR9h5UFgfvfcG9U42dyZUx56rfaX8ZitoPhBoKeTj5qSiVaL

DCRU: Clinical Research Unit Resource Request

Returning?

A A A

Thank you for requesting DCRU services!

Please contact us at either 216-844-4902 if you need any assistance.

Application Date

* must provide value

M-D-Y

Principal Investigator: Last Name

* must provide value

Principal Investigator: First Name

* must provide value

Principal Investigator: Email, if not using UH email

Department

Other Department (specify)

Division

Other Division (specify)

Accessed from Velos?

Yes

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Does this study utilize a Coordinator from the UHCRC Support Core?

* must provide value

Yes

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Will this study ONLY utilize DCRU room space in Lakeside 6500 or Bolwell 3400 and no other DCRU core services?

A "Yes" answer indicates the study will NOT require DCRU Nursing, Sample Processing, Analytical Lab, or Bionutrition services.

Yes

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Regulatory Contact: Last Name

Regulatory Contact: First Name

Regulatory Email, if not using UH email

Study Coordinator: Last Name

Study Coordinator: First Name

Study Coordinator Email, if not UH email

Person completing this form:

Principal Investigator (as listed above)

Study Coordinator (as listed above)

Regulatory (as listed above)

Other (please specify below)

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Person completing form: Last Name

Person completing form: First Name

Person completing form Email, if not UH

Protocol Short Title / Nickname

Velos Study Number

Full Protocol Title

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Does this study include pediatric patients age 21 & under?

Yes

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Will drug administration occur in this space?

Yes

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Is the study AIDS-related?

Yes

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Does the study involve an Investigational Drug or an Investigational medical device?

Investigational Drug (IND)

Investigational Medical Device (IDE)

Neither (no investigational drug or device)

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IND Number (4-6 digits)

Name of Investigational Drug

IND Holder/Sponsor

Investigator

Group/Organization

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Name of Holder/Sponsor

IDE Number (4-6 digits)

Name of Investigational Device

IDE Holder/Sponsor

Investigator

Group/Organization

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Name of Holder/Sponsor

Select Study Phase

Pilot

I - First stage testing in humans

Ia - Single ascending dose

Ib - Multiple ascending dose

II - Safety and efficacy

IIa - Dosing requirements

IIb - Drug efficacy

III - Effectiveness of new intervention in clinical practice

IV - Postmarketing and/or safety surveillance

V - Translational Research

N/A

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If Investigational Medical Device (IDE), please specify the Medical Device Class

Class I - Minimal risk to users

Class II - Moderate risk to users

Class III - High-risk to users or devices not significantly equivalent to Class I or II

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For IDE Class II or III, please provide 510(K) or PMA information (including application #, title, "holder" of 510(K) or PMA)

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If Investigational Medical Device (IDE), please indicate the Study Phase

I - Pilot/Feasibility

III - Pivotal

IV - Post-marketing

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If No Investigational Drug or Device, please indicate Study Phase

Pilot

I - First stage of testing in humans

II - Safety and efficacy

III - Effectiveness of new intervention in clinical practice

IV - Safety surveillance

V - Comparative effectiveness or community-based research. Integration of a new clinical treatment into public health practice

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Is this an Oncology study?

* must provide value

Yes

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REMINDER OF CRITICAL REGULATION: ANYTHING* that is administered to a patient must initially go through IDS (Investigative Drug Services) for review and EITHER be dispensed through IDS OR you must file for an Exception.

*Anything means everything, including gases or seemingly innocuous items such as grape powder. See UH policy MM-4, Investigational Products.
Questions? Email IDS@uhhospitals.org

Is this a 90 day activation?

Yes

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Enter PRMC approval date

M-D-Y

Is PRMC approval date:

Actual

Estimated

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Enter the 90 day activation date

M-D-Y

90 day activation date (calculated from PRMC approval date)

View equation

Is expedited activation required?

Yes

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Expedited activation date:

M-D-Y

Why is expedited activation required?

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Research Specialist: Last Name

Research Specialist: First Name

Research Specialist Email, if not UH

Data Manager: Last Name

Data Manager: First Name

Data Manager Email, if not UH

Data Manager: Phone

ClinicalTrials.gov ID (NCT number - 8 digits)

Funding Source for this study

* must provide value

Industry

Investigator-initiated (NIH, Foundation, Department funded, etc)

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Funding: Industry
Sponsor/Company Name

Funding: Industry
Please suppy UH PTAEO/Award associated with this study

Funding: Industry
Has the UH contract been finalized?

Yes

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Funding: Industry
Anticipated SIV (site initiation visit) date

M-D-Y

Funding: Investigator-Initiated
Source of funding

NIH

Foundation

Department Funded

Other

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Funding: Investigator-initiated - NIH
Enter ERA Commons ID

Funding: Investigator-initiated - NIH
What is the Case Speedtype associated with this study

Funding: Investigator-initiated - Foundation
Enter the name of the Foundation

Funding: Investigator-initiated
What is the funding account number associated with this trial (Case or UH)

Funding: Department-funded
Department Name

Funding: Investigator-initiated - Other
Describe OTHER funding source and funding dates

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Finance Contact: Last Name
(Person that manages study budget and funding)

Finance Contact: First Name

Finance Contact: Email, if not UH

Is this a Multi-center trial (MCT)?

Yes

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MCT: National enrollment opening date

M-D-Y

MCT: National target enrollment

MCT: Has enrollment begun at UHCMC?

Yes

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MCT: Date enrollment started at UHCMC

M-D-Y

IRB Status

Not yet submitted

Submitted, pending outcome

Approved

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Anticipated date of IRB submission

M-D-Y

Date of IRB submission

M-D-Y

Date of IRB approval

M-D-Y

IRB of Record

University Hospitals Cleveland Medical Center

Case Western Reserve University

Advarra IRB (previously Chesapeake)

NCI CIRB

Cleveland Clinic

MetroHealth Medical Center

Reliant Review (specific which below)

Western IRB (WIRB)

Other

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Specify which Other IRB you are submitting to

IRB - Specify which Reliant Review you are submitting to

Reliant Review - Cincinnati's Children's Hospital Med Ctr

Reliant Review - Cleveland Clinic

Reliant Review - CWRU

Reliant Review - MetroHealth

Reliant Review - Nationwide Children's Hospital

Reliant Review - The Ohio State University

Reliant Review - University of Cincinnati

Reliant Review - Other

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Please specify which Other Reliant Review you are submitting to

IRB Number

Anticipated start date for DCRU services

M-D-Y

Target number of participants for DCRU services

Anticipated length of the trial (number of months)

Are patients already identified for screening?

Yes

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You have selected an option that triggers this survey to end right now.

To save your responses and end the survey, click the 'End Survey' button below. If you have selected the wrong option by accident and/or wish to return to the survey, click the 'Return and Edit Response' button.