Today M-D-Y Date form was initiated
Name of person submitting this form
Submitter Email
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Email address of person submitting form
Type n/a if none exists
Please upload the protocol
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Full Protocol Title
Study Short Name
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IMPORTANT: THIS IS THE NAME OF YOUR STUDY AS IT WILL APPEAR IN EPIC! The name in EPIC will appear [PI last name]-[study short name]
IRB Number
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Use RAP IRB#
Study Type
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Drug Observational Device Chart Review Expanded Access Other
Define Other Study Type
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Define other study type
Study Funding
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Industry/Pharmaceutical Government/Grant Investigator Initiated Cooperative Group Other
Is this a COVID-19 related study?
Yes
No
IRB of record
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UC WIRB/WCG Advarra Other
Define Other IRB
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Department
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Addiction Sciences Allied Sciences Anesthesiology Cardiology CCHMC Dermatology Digestive Diseases Emergency Medicine Endocrinology ENT (Ear, Nose and Throat) Family Medicine Hematology/Oncology HUDs Immunology Infectious Disease Interstitial Neonatology Nephrology Neurology Neurosurgery Nursing OBGYN Ophthalmology Oral Surgery Orthopaedics Otolaryngology Pathology Pediatrics Pharmacy Physical Medicine & Rehabilitation Psychiatry Pulmonary Radiology Rheumatology Surgery Transplant Trauma Urology Other
We will add your department to the list
What entity is the study contracted through?
University of Cincinnati
UC Health
Other
University of Cincinnati
UC Health
Other
Define other contracting entity
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Kuali or CWMS/Icertis #
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National Clinical Trial #
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Example: NCT00000000
Place a link to the Clinicaltrials.gov listing in Epic/Mychart?
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Yes
No
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
Providing this will allow for a link to the CT.gov listing to be viewable in Epic and MyChart
Duration of Study
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Today M-D-Y ~ Study End Date
Expected number of participants
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Principal Investigator First Name
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Principal Investigator Last Name
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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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Billing Setup
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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.
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.
Does this study include any research billable (sponsor/study-paid) items?
Yes
No
WARNING : BY SELECTING THIS OPTION, ALL CHARGES ALL STUDY WILL By indicating that this study has no research-billable items, all charges associated with this study's linked encounters will be billed to the patient/insurance/third-party payer. Please be sure that all charges for this study are standard of care (SOC) without any exceptions (including phlebotomy, labs, and imaging).
Billing patients/insurance for study-related activities outside of SOC must not occur. It is a signifcant regulatory violation that may result in substantial liablities to the organization and study team.
If there are expected to be ANY study-billable charges for this study, please select the appropriate billing option in the previous field, then indicate which CPT codes or procedures may be study-billable in the subsequent fields. OCR will work with you to ensure these codes are accurate and appropriately built in Epic to trigger the reserach billing review process.
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Yes. I've read this warning and confirm there are no study-billable items for this study
Yes. I've read this warning and confirm there are no study-billable items for this study
Does this study have a completed/pending Coverage Analysis?
All qualifying clinical trials, including federally-funded studies, require a coverage analysis. If needed, contact the OCR for guidance.
Yes
No
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)
Department
OCR (Office of Clinical Research)
Is coverage analysis for this study complete and currently available for upload?
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Yes
No
Please upload completed coverage analysisBe 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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Please upload coverage analysis details
Please provide the email address of the party responsible for providing coverage analysis to OCR upon completion. The OCR team will reach out to this party via email to coordinate next steps.
NOTE: FAILURE TO PROVIDE COVERAGE ANALYSIS WILL
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Please provide CPT codes for all billable items
CPT codes are needed for billing review and creation of the study's research encounter form (REF).
Failure to provide billing codes for the study may result in a significant billing review delay.
If you do not know the CPT codes for all billable items in this study, please contact your business administrator for guidance.
Please provide CPT codes for all billable items
CPT codes are needed for billing review and creation of the study's research encounter form (REF).
Failure to provide billing codes for the study may result in a significant billing review delay.
If you do not know the CPT codes for all billable items in this study, please contact your business administrator for guidance.
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Please provide only numerical CPT codes
Where are the study funds held?
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UC
UCPC
Other
Account StringNote: Failure to provide this information may cause a delay in study approval. The account string must follow the format shown below.
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Billing Contact Name
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This is likely your business administrator, but can also be a generic contact, i.e. "[Department] Research Billing", etc.
This is likely your business administrator, but can also be a generic/shared department billing email.
Street Address
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State
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Does this study involve Investigational Drug Services (IDS)?
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Yes
No
Please upload the pharmacy manual.
Describe in what capacity IDS will be involved. Reference specific pages/sections in the protocol if possible.
Does this study involve Investigational Imaging Services (IIS)?
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Yes
No
IIS is any imaging (standard or non-standard, including but not limited to): CT, MRI, PET/CT, US, X-Ray, Fluoroscopy, DXA, Bone Scan, Mammography, image guided procedures, and disk requests for sending imaging to sponsors.
IMPORTANT:
Investigational Imaging requires that clinical research utilizing the imaging services described above complete the following form:Radiology Research Needs Assessment
Is there an imaging manual?
Yes
No
Please upload the imaging manual.
Please upload the Investigational Imaging Request Form
Describe in what capacity IIS will be involved. Reference specific pages/sections in the protocol if possible.
Does this study involve UC Health Lab?
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Yes
No
Please upload the lab manual.
Describe in what capacity Lab will be involved. Reference specific pages/sections in the protocol if possible.
Sites
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WCH Building/Unit/Clinic
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Do you wish to utilize Epic Research Tools?
Yes
No
Which tools would you like to use?
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Point of Care Recruitment
This alert appears in EPIC to any provider (i.e. Physician, Nurse, Midlevel) whose patient may meet specific criteria.
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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Please be specific
MD, DO, PA, RN, etc.
Inclusion Criteria (please be as specific as possible, i.e. gender, age, diagnosis, lab value)
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Exclusion Criteria (please be as specific as possible, i.e. gender, age, diagnosis, lab value, specific medication, procedure)
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When to send alerts to InBasket
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Patient is Interested Patient Declined Both
Patient responses will be routed to an Epic InBasket
Pool Individual
Please provide the names of the individuals to receive InBasket messages
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
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IRB-approved patient-facing alert message
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This is generally the language that you would use on a tear pad. However, other language may be used if desired. Please contact Miranda.Gulasy@UCHealth.com to create tear pad language.
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.
Inclusion Criteria (please be as specific as possible, i.e. gender, age, diagnosis, lab 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
When to send alerts to InBasket
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Patient is Interested Patient Declined Both
Patient responses will be routed to an epic InBasket
Pool Individual(s)
Please provide the names of the individuals to receive InBasket messages
Results Alert
InBasket alert for results
When to send alert to InBasket
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Normal results Abnormal results Both
Results are routed to InBasket
Default Pool Individual(s)
Default= coordinators listed on study record
Please provide the names of the individuals to receive InBasket messages
Is this study IRB approved?
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Yes
No
Please upload your IRB approval letter here. If your study is being reviewed by an external IRB, please upload the external IRB approval letter.
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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: ______ ______ is in agreement with the information provided here.
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Additional Document Upload
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Additional Document Upload
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Additional Document Upload
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