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/^((02([-\/])29\3(\d{2}([13579][26]|[2468][048]|04|08)|(1600|2[048]00)))|((((0[1-9]|1[012])([-\/])(0[1-9]|1\d|2[0-8]))|((0[13-9]|1[012])([-\/])(29|30))|((0[13578]|1[02])([-\/])31))(\11|\15|\19)\d{4}))$/

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8hBdj7ILIUT4kZ76PmxFVYtk5k2ToyjwLnpsQcWg7RirS5jLxjKbfZ3FPbsD447mFcRt6

UC Health Research Approval

Date of Submission

M-D-Y

Submitter Name

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Submitter Email

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Protocol Number

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Please upload the protocol

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Study Title

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Study Short Name

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IRB Number

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Study Type

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Define Other Study Type

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Study Funding

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Is this a COVID-19 related study?

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Yes

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IRB of record

* must provide value

Define Other IRB

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Department

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Define Other Department

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What entity is the study contracted through?

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University of Cincinnati

UC Health

Other

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Define other contracting entity

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Kuali or CWMS #

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National Clinical Trial #

This field is required. If no NCT # exists, please type "n/a"

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Place a link to the Clinicaltrials.gov listing in Epic/Mychart?

* must provide value

Yes

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Clinicaltrials.gov URL

Must be a URL (http:// or https://)

Do not put "N/A" or anything other than a URL value. Leave blank or select "no" above if you do not want a URL placed in Epic

Duration of Study

* must provide value

M-D-Y

Expected number of participants

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Principal Investigator First Name

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Principal Investigator Last Name

* must provide value

Primary Coordinator Name

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Primary Coordinator Email

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A brief synopsis of the study and/or intervention. Include all details that might impact patient care.

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Business Administrator Name

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Business Administrator Email

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Business Fax Number

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Street Address

* must provide value

City

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State

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Zip

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Where are the study funds held?

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UCPC

Other

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Billing Setup

* must provide value

This study does not include research billable items.

This study is a qualifying clinical trial and has had a Medicare Coverage Analysis (MCA) completed.

This study is not a qualifying clinical trial, but still has research billable items.

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Who has completed the coverage analysis for this study?

The Office of Clinical Research (OCR) typically completes coverage analysis for all industry trials. Non-industry trials' coverage analyses are managed by the submitting department unless a special request/arrangement has been made with OCR for them to complete the coverage analysis.

Department

OCR (Office of Clinical Research)

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Please upload completed coverage analysis
Be sure all relevant research-billable CPT codes are included in the file, as this information is used to generate Research Encounter Forms (REFs) and Epic Research Billing setup.

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By selecting that this study has no research billable items, any charge associated with an encounter linked to this study will bill to the patient/third party payer.

Account String

Note: Failure to provide this information may cause a delay in study approval. The account string must follow the format shown below. Do not include just the T-Number.

Please include the entire account string following the format shown in the example. You may have to contact your departmental business administrator for this information.

Example:
F00-0000-T0000000-0000000000-0000-00000-000
or
G000000-0000000000-0-0000000

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Please provide CPT codes for all billable items

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Does this study involve Investigational Drug Services (IDS)?

* must provide value

Yes

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Please upload the pharmacy manual.

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Describe in what capacity IDS will be involved. Reference specific pages/sections in the protocol if possible.

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Does this study involve Investigational Imaging Services (IIS)?

* must provide value

Yes

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IMPORTANT:

Investigational Imaging requires that clinical research utilizing the imaging services described above complete the following form:

Radiology Research Needs Assessment

This form will collect the necessary information the Radiology department needs to assess the operational feasibility of the clinical research study. If this form has already been submitted, please proceed with your submission.

Is there an imaging manual?

Yes

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Please upload the imaging manual.

Upload file

Please upload the Investigational Imaging Request Form

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Describe in what capacity IIS will be involved. Reference specific pages/sections in the protocol if possible.

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Does this study involve UC Health Lab?

* must provide value

Yes

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Please upload the lab manual.

Upload file

Describe in what capacity Lab will be involved. Reference specific pages/sections in the protocol if possible.

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Sites

* must provide value

University of Cincinnati Medical Center (UCMC)

UC Physicians (Non Hospital Based Clinics, UCPC)

West Chester Hospital (WCH)

The Drake Center (TDC)

WCH Building/Unit/Clinic

* must provide value

Yes

Will investigational medication be administered at WCH?

* must provide value

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Will an investigational device be initiated at WCH?

* must provide value

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Will an investigational procedure be performed at WCH?

* must provide value

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Will a radiologic procedure for research be performed at WCH?

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Do you wish to utilize Epic Research Tools?

Yes

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Which tools would you like to use?

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Point of Care Recruitment

MyChart Recruitment

Research Results Alert

Point of Care Recruitment

This alert appears in EPIC to any provider (i.e. Physician, Nurse, Midlevel) whose patient may meet specific criterion.

Text to display to providers

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Provider name(s) that should see alert

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Location(s) that should see the alert

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Department(s) that should see the alert

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Provider type(s)

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Inclusion Criteria (please be as specific as possible, i.e. gender, age, diagnosis, lab value)

* must provide value

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Exclusion Criteria (please be as specific as possible, i.e. gender, age, diagnosis, lab value, specific medication, procedure)

* must provide value

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When to send alerts to InBasket

* must provide value

InBasket alert target

* must provide value

Epic pool name

* must provide value

Individual(s)

* must provide value

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MyChart Recruitment

This alert appears to patients who are active myChart users meeting specific study criterion.

You MUST have an IRB approved partial HIPAA waiver in place to utilize this tool.

Patient-facing study name

* must provide value

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IRB-approved patient-facing alert message

* must provide value

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Please upload the IRB-approved partial HIPAA waiver

If this document is not available at this time, it must be provided to Research-Admin@UCHealth.com before the tool can be activated.

Upload file

Inclusion Criteria (please be as specific as possible, i.e. gender, age, diagnosis, lab value)

* must provide value

Expand

Exclusion Criteria (please be as specific as possible, i.e. gender, age, diagnosis, lab value, specific medication, procedure)

* must provide value

Expand

When to send alerts to InBasket

* must provide value

InBasket alert target

* must provide value

Epic pool name

* must provide value

Individual(s)

* must provide value

Expand

Results Alert

InBasket alert for results

When to send alert to InBasket

* must provide value

Alert target

* must provide value

Pool name

* must provide value

Individual(s)

* must provide value

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Is this study IRB approved?

* must provide value

Yes

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Please upload your IRB approval letter here. If your study is being reviewed by an external IRB, please upload the external IRB approval letter.

* must provide value

Upload file

UC Health Research Approval cannot be released without IRB approval. This form can still be submitted at this time.

Once your study has been IRB approved, you MUST contact Research-Admin@UCHealth.com and update the status. Please reference the study name included in your confirmation email and attach the approval letter.

Attestation Statement:

I confirm that by making this submission that the Principal Investigator for this study: ______ ______ is in agreement with the information provided here.

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Yes

Additional Submission Comments

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Additional Document Upload

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Document Description

Additional Document Upload

Upload file

Document Description

Additional Document Upload

Upload file

Document Description

Submission Timestamp

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M-D-Y H:M

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UC Health Research Approval

Study Information

Business Administration

Services and Sites

Submission

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