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Required format:

xdSRWqyx7Dxa27KV3EJK6mUiP8eDfVmdbXHBVLwCwhb2VzQmn9GxfpMc736dFQRgQWgTENCPDJwWn

UHT Research Services Request Form

Information when Requesting UHT Research Services:

Email and Contact Information:

For Non-Oncology Study protocols:

UHTresearch@med.miami.edu

For Oncology Study Protocols:

UHTOncoResearch@miami.edu

Details on Ancillary Process

UHT Ancillary Team reviews the UHT Research Services Form and requests additional information as needed.
UHT Ancillary Team communicates with the study team on the Feasibility Research Committee (FRC) date.
IRB approved (study team notifies UHT Ancillary Team via email with the approval letter from Local IRB or Central IRB.
Staff on affected floors must be in-serviced on the research study, and a copy must be submitted to UHT Ancillary Team UHTresearch@med.miami.edu or UHTOncoResearch@miami.edu
Device Studies: Biomed to perform an initial inspection and issue an assessment report.

IRB Number:

* must provide value

Title of the Study:

Principal Investigator Last Name:

* must provide value

Principal Investigator First Name:

* must provide value

Principal Investigator Cell Phone Number:

* must provide value

Principal Investigator Office Number:

Principal Investigator Email Address:

Does the Principal Investigator have privileges to perform the Study Protocol at UHT?

Yes

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Principal Investigator Department:

* must provide value

If Other, Please specify

Please specify which Division

Specify or list Co-Principal Investigators and Sub-Investigators

Clinical Research Coordinator Name:

* must provide value

Clinical Research Coordinator Cell Number:

Clinical Research Coordinator E-mail Address:

Finance Contact Name:

Finance Contact Office Number:

Finance Contact Email:

Is this study considered an Emergency IND with FDA Approval?

* must provide value

Yes

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Is this Clinical Study Design the following:

* must provide value

In-Patient

Out-Patient

Hybrid (In-patient and Out-patient)

Chart Review

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If In-Patient or Hybrid, Will this require a Direct/ Scheduled Admission?

Yes

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If In-Patient or Hybrid, Please specify Days of admission:

If In-Patient or Hybrid, Will this protocol be screening/ consenting from an In-Patient Census?

Yes

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If In-Patient or Hybrid, What Floor/Unit should the patient be admitted to?

Please select if this protocol is:

* must provide value

Oncology Protocol

Non-Oncology

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Study Type/ Study Design

* must provide value

Drug

Biologic

Observational

Registry

Creating Database

Therapeutic

Prospective

Double Blinded

Placebo Controlled

Survey

Device Study

Epidemiologic

Diagnostic

Stratification

* must provide value

Randomized

Not Randomized

Phase Of the Study

* must provide value

Drugs or Device being investigated

Funding Source

* must provide value

Federal

Industry

State

Foundation

Internally Funded

Department Funded (PI Initiated)

No Funded

Other

Please specify other funding sources

Upload Latest version of Clinical Study Protocol

* must provide value

Upload file

Upload Pharmacy Manual

Upload file

Upload Laboratory Manual

Upload file

Please provide the Clinical Study Budget Agreement

* must provide value

Upload file

Sponsor/ Manufacturer Name:

* must provide value

Does the study involve an IND (Investigational New Drug)/ IDE (Investigational Device Exemption):

* must provide value

Yes

N/A

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If Yes,
Specify IND/IDE Number:

If Yes,
Upload Investigator Brochure/ Product Labeling

Upload file

Name of Investigational Product

* must provide value

Route of Medication Administration

* must provide value

SubQ

Nebulization

Intrathecal

IR Assisted

Surgically Placed

Lumbar Puncture

Other

If Other, Please specify:

Are these products FDA Approved?

* must provide value

Yes

N/A

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Who will provide the Investigational Product(s)?

Manufacturer

Sponsor

Physician/Practice Group

UHT Pharmacy

Other

If Other, Please specify.

Where will the Drug/Device/Agent be Stored?

Date requested for SIV

M-D-Y

Estimated Duration of Study

Projected Protocol Start Date (Month/Year)

* must provide value

Projected Protocol End Date

M-D-Y

Number of Subjects to be Enrolled

* must provide value

Will you need to recruit in the Emergency Department?

Yes

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UHT Services/Resources Required:

* must provide value

Nutrition

Pharmacy

Nursing Services

Radiology

Cardiology

Pathology/ Laboratory

Surgical Services

Interventional Radiology

Cath Lab

Other Services

If Nutrition, Please specify: (i.e. Diet, etc)

* must provide value

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If Pharmacy, Please specify: (i.e. Storage, Dispensing, Temperature Monitore, etc)

* must provide value

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If Nursing Services, Please specify: (i.e. SOC, Medication Administration, Specimen Collection, Etc)

* must provide value

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If Radiology Services, Please specify: (i.e. SOC, CT Scan, MRI, Ultrasound, Etc)

* must provide value

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If Cardiology Services, Please specify: (i.e. SOC, EKG, ECHO, Etc)

* must provide value

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If Pathology Services, Please specify: (i.e. Phlebotomy, Specimen Processing, PK Sampling, Etc)

* must provide value

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If Surgical Services, Please specify: (i.e. Biopsy, Etc)

* must provide value

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If Interventional Radiology Services, Please specify: (i.e. infusion, Etc)

* must provide value

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If Cath Lab Services, Please specify:

* must provide value

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If Other, Please Specify

* must provide value

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