Fields with a red star (*)are required. Project Title OnCore Protocol No. Refer to the OnCore protocol decision tree for additional guidance. Use your standard Short Title naming if project will never be in OnCore. NEW JULY 2023: The MCW Office of Research (MCW OOR) is now requiring use of OnCore for all new studies that involve Froedtert Health Charges and/or MCW Professional Charges requiring Epic billing. MCW OOR is defining “New” protocols as those that have not yet initiated any pricing/budget components as of July 10, 2023. If Budget Development/Pricing activities have already been initiated prior to July 10, 2023, then pre-reviews must occur with the MCW OOR. For studies that do not require entry into OnCore Financials at this time, an exception memo from the MCW OOR will be required to be submitted with the OCRICC application. For all other new studies, protocol entry into OnCore is strongly recommended per the OnCore protocol decision tree. More details can be found in the OnCore Financials Toolbox. Please contact the MCW Financials Team at [email protected] with questions. Will this project involve Froedtert Health Charges and/or MCW Professional Charges requiring Epic billing AND use OnCore Financials? Yes – OnCore Financials is being used for this project and the billing grid status is “CRC sign off” No – I have an approved exception memo from the MCW Office of Research for this project, OnCore financials will not be used No – my project does not involve Froedtert Health Charges and/or MCW Professional Charges requiring Epic billing No – I am a Froedtert investigator and do not use OnCore AND/OR my project is not formal research (Innovative Care or other unique research adjacent request) Will this project otherwise be built in OnCore for study status and subject status tracking? Yes No Will this study require a Study Record (RSH) to be created in EPIC? Yes No Check the EPIC RSH Study Record Creation Decision Tree (PDF) if you are unsure. Will this study use Florence eBinders? Yes No Check the Florence eBinders Support page if you are unsure. Do you have an IRB Number? Yes, I can enter it now. The IRB number assignment is pending. No, there will never be an IRB number for this. IRB Number Will the MCW IRB rely on an outside IRB for this project? Yes No You will be required to upload the completed reliance agreement or the e-mail statement of approval from the MCW IRB Reliance team. NCT Number Enter zeros if no NCT number will ever be assigned. Project Staff Information Principal Investigator (PI) PI Employer (i.e. MCW) PI Department PI Research Division Enter if different than department. PI E-Mail Primary Research Team Contact Information Name Research Division/Department E-mail Phone OnCore Financials Contact Person Information (if applicable) Name Email Phone Invoicing Contact Person Information Name E-mail Phone Sponsor Information Funding Source Industry NIH Grant Other Grant Not Funded Sponsor Name If there is more than one Sponsor, please add additional fields by clicking the plus sign on the far right or entering a number in the box below and clicking the word "Add" to the left of the box. Sponsor Name Sponsor Name Item weight Add Add more items more items Project Information Disease State Under Investigation Type of Project Device Project (Category A/B IDE, PMA, or other) Comparative Coverage with Evidence Development (CED) Data/Specimen Collection (blood, urine, stool, etc.) WITH consent Data/Specimen Collection (blood, urine, stool, etc.) WITHOUT consent IND Drug or Biologic Project IND Drug or Biologic HGT/rDNA Project INVOLVING Cell Therapy Services IND Exempt Drug or Biologic Project Innovative Care (Emergency Use, Compassionate use, Humanitarian Use) Observational Retrospective and/or Prospective Data Collection Only With waiver of consent and authorization Limited Froedtert Heath Resource Use For example: Consent management-only projects (Consenting Froedtert Health patients for access to their PHI is the only Froedtert Health resource being used, with no invoicing or claims management requirements) Invoice-only projects where there are three (3) or less Froedtert Health resources to be ordered as normal and invoiced to the study (for example, Froedtert Health imaging services such as MRI, CT, X-ray, Echo) Use of only Froedtert Health IDS, but all other activities take place in MCW space Request for Letter of Support (LOS) for Grant Application (upload a statement of commitment - e-mail or other documentation - from the leadership supporting your project if applicable) Request for EPIC RSH Study record build when there is no FH impact but a record is needed to facilitate MCW billing needs or MyChart Recruitment Reporting. *STOP* You do not need to get Froedtert Health administrative approval if your project is solely data collection with an IRB-approved waiver of consent and authorization. All you will need to do is complete the web-based Accounting Log Form. *STOP* For this type of request, use the Additional Details free-text box to communicate your intended plan in lieu of an Operational Feasibility Tool. Upload the documents that are pertinent to your limited-use project (protocol summary, ICF, imaging guidelines, etc.). For CCCTO Clinical Trials Only: Will the MCA be outsourced? Yes – MCA entered into OnCore Financials Yes – approved exception from OnCore Financials No For this type of Innovative Care project, a completed Operational Feasibility Tool is NOT required at time of this application. Does this project require services, resources, or support from a Froedtert Health affiliate or will it be conducted in a Froedtert Health affiliate location? Yes No *STOP* You do not need FH administrative approval if your project will not use any Froedtert resources and all research activities will be conducted in MCW space. If you are unsure whether the resources involved in your project are FH resources, do not complete an application, contact us at [email protected] or 414-805-4082 to discuss. Does this project require radiology, cardiology, or other images to be sent to sponsor throughout project? Yes No Does this project require pricing for any Froedtert Health resource/service(s)? Yes No Did you obtain any preliminary pricing via the Froedtert Health Research Chargemaster? Yes No Upload a document identifying these services and their corresponding CPT codes in the Project Documents section below. Do you require any additional pricing for Froedtert Health resources or services? Yes No Did you obtain preliminary pricing from OCRICC via the Request for Froedtert Health Research Pricing Application? Yes No Service Descriptions and CPT Code Instructions For most efficient service, research staff should identify CPT codes for the services needing to be priced. If there is no CPT code, research staff should identify a CPT code for a comparable procedure, making note of this detail on the request form. If the correct CPT code or comparable CPT code/procedure is not known, research staff should ask the sponsor or PI. If the sponsor cannot provide, or PI does not know, the research team should contact their MCW Department resource that manages professional billing/coding. Research staff can expect that, if they provide CPT codes for each service when requesting pricing, OCRICC will be able to complete these requests within 5 business days. Researchers submitting pricing requests without corresponding CPT codes may experience a delayed turnaround. Services for Pricing Re-order Service Description CPT Code Department Providing Service Weight Operations Service Description CPT Code Department Providing Service Item weight Add Add more items more items To add more lines, click the plus sign on the far right or enter the number of items in the box above and click the word "Add" to the left of it. Enter your assigned OCRICC Project number. This number was provided to you when you submitted the Froedtert Health Pricing Application to OCRICC. Additional Details Project Documents Attaching all required documents will support OCRICC’s timely and efficient operational and financial feasibility review. A project cannot be initiated without all required documents. File names should not include any characters other than hyphens (-) and underscores (_). There should only be one period (.) in the file name before the file extension (for example, xyz-protocol.docx). NOTE: If during the initial review of your application any project-specific documents are found to be missing, your application will be placed on hold and returned to you with instruction. Protocol (REQUIRED) Upload File names should not include any characters other than hyphens (-) and underscores (_). There should only be one period (.) in the file name before the file extension (for example, xyz-protocol.docx).One file only.256 MB limit.Allowed types: pdf, doc, docx, odt, ppt, pptx, odp, xls, xlsx, ods. There will be a slight delay while your file is scanned for potential viruses. Please do not refresh or click the back button. Informed Consent Form(s) Upload Document must be in its final negotiated state, i.e. the ICF version that will be submitted to the IRB.New JULY 2023: For projects being managed in OnCore Financials, draft ICF is acceptable. Costs section must align with what is reflected in the Billing Grid as research paid versus standard of care. File names should not include any characters other than hyphens (-) and underscores (_). There should only be one period (.) in the file name before the file extension (for example, xyz-informed-consent-form1.docx).Unlimited number of files can be uploaded to this field.256 MB limit.Allowed types: pdf, doc, docx, odt, ppt, pptx, odp, xls, xlsx, ods. There will be a slight delay while your file is scanned for potential viruses. Please do not refresh or click the back button. Schedule of Events Upload Required for projects that will not have an OnCore Financials Billing Grid. Document must identify items/services as "Research" or "Standard of Care." See example in the MCA Guidance Document. We will also accept: •Comparable documentation of Research vs. Standard of Care •A detailed statement of what is Research vs. Standard of Care File names should not include any characters other than hyphens (-) and underscores (_). There should only be one period (.) in the file name before the file extension (for example, xyz-schedule-of-events.docx).One file only.256 MB limit.Allowed types: pdf, doc, docx, odt, ppt, pptx, odp, xls, xlsx, ods. There will be a slight delay while your file is scanned for potential viruses. Please do not refresh or click the back button. FDA Approval Letter (Unredacted) Upload File names should not include any characters other than hyphens (-) and underscores (_). There should only be one period (.) in the file name before the file extension (for example, xyz-operational-feasibility-tool.pdf).One file only.256 MB limit.Allowed types: pdf, doc, docx, odt, ppt, pptx, odp, xls, xlsx, ods. There will be a slight delay while your file is scanned for potential viruses. Please do not refresh or click the back button. CMS Device Approval Letter(s) Upload File names should not include any characters other than hyphens (-) and underscores (_). There should only be one period (.) in the file name before the file extension (for example, xyz-cms-device-approval-letter.pdf).Unlimited number of files can be uploaded to this field.256 MB limit.Allowed types: pdf, doc, docx, odt, ppt, pptx, odp, xls, xlsx, ods. There will be a slight delay while your file is scanned for potential viruses. Please do not refresh or click the back button. Completed Operational Feasibility Tool Upload Download the Operational Feasibility Tool PDF form.One file only.256 MB limit.Allowed types: pdf, doc, docx, odt, ppt, pptx, odp, xls, xlsx, ods. There will be a slight delay while your file is scanned for potential viruses. Please do not refresh or click the back button. Pricing from Research Chargemaster Upload File names should not include any characters other than hyphens (-) and underscores (_). There should only be one period (.) in the file name before the file extension (for example, xyz-pricing-from-research-chargemaster.docx).Unlimited number of files can be uploaded to this field.256 MB limit.Allowed types: pdf, doc, docx, odt, ppt, pptx, odp, xls, xlsx, ods. There will be a slight delay while your file is scanned for potential viruses. Please do not refresh or click the back button. Reliance Approval Documentation Upload File names should not include any characters other than hyphens (-) and underscores (_). There should only be one period (.) in the file name before the file extension (for example, xyz-reliance-approval.docx).One file only.256 MB limit.Allowed types: txt, rtf, pdf, doc, docx, odt, ppt, pptx, odp, xls, xlsx, ods. There will be a slight delay while your file is scanned for potential viruses. Please do not refresh or click the back button. Imaging Manual(s) or Guidelines Upload Include when applicable, and include for each imaging modality. File names should not include any characters other than hyphens (-) and underscores (_). There should only be one period (.) in the file name before the file extension (for example, xyz-imaging-manual1.pdf).Unlimited number of files can be uploaded to this field.256 MB limit.Allowed types: pdf, doc, docx, odt, ppt, pptx, odp, xls, xlsx, ods. There will be a slight delay while your file is scanned for potential viruses. Please do not refresh or click the back button. Echocardiography Manual(s) Upload Include when applicable. File names should not include any characters other than hyphens (-) and underscores (_). There should only be one period (.) in the file name before the file extension (for example, xyz-echo-manual.pdf).Unlimited number of files can be uploaded to this field.256 MB limit.Allowed types: pdf, doc, docx, odt, ppt, pptx, odp, xls, xlsx, ods. There will be a slight delay while your file is scanned for potential viruses. Please do not refresh or click the back button. Device Manual(s)/Instructions for Use Upload File names should not include any characters other than hyphens (-) and underscores (_). There should only be one period (.) in the file name before the file extension (for example, xyz-device-manual3.pdf).Unlimited number of files can be uploaded to this field.256 MB limit.Allowed types: pdf, doc, docx, odt, ppt, pptx, odp, xls, xlsx, ods. There will be a slight delay while your file is scanned for potential viruses. Please do not refresh or click the back button. Outsourced MCA (CCCTO trials only) Upload File names should not include any characters other than hyphens (-) and underscores (_). There should only be one period (.) in the file name before the file extension (for example, xyz-outsourced-mca.pdf).One file only.256 MB limit.Allowed types: pdf, doc, docx, odt, ppt, pptx, odp, xls, xlsx, ods. There will be a slight delay while your file is scanned for potential viruses. Please do not refresh or click the back button. Surgical Manual(s) Upload Include when applicable. File names should not include any characters other than hyphens (-) and underscores (_). There should only be one period (.) in the file name before the file extension (for example, xyz-surgical-manual2.pdf).Unlimited number of files can be uploaded to this field.256 MB limit.Allowed types: pdf, doc, docx, odt, ppt, pptx, odp, xls, xlsx, ods. There will be a slight delay while your file is scanned for potential viruses. Please do not refresh or click the back button. Staff Training Materials Upload Include when applicable. File names should not include any characters other than hyphens (-) and underscores (_). There should only be one period (.) in the file name before the file extension (for example, xyz-staff-training4.docx).Unlimited number of files can be uploaded to this field.256 MB limit.Allowed types: pdf, doc, docx, odt, ppt, pptx, odp, xls, xlsx, ods. There will be a slight delay while your file is scanned for potential viruses. Please do not refresh or click the back button. Cell Processing Manual Upload Include when applicable. File names should not include any characters other than hyphens (-) and underscores (_). There should only be one period (.) in the file name before the file extension (for example, xyz-staff-training4.docx).Unlimited number of files can be uploaded to this field.256 MB limit.Allowed types: pdf, doc, docx, odt, ppt, pptx, odp, xls, xlsx, ods. There will be a slight delay while your file is scanned for potential viruses. Please do not refresh or click the back button. IBC Approval Letter Upload Include when applicable. File names should not include any characters other than hyphens (-) and underscores (_). There should only be one period (.) in the file name before the file extension (for example, xyz-staff-training4.docx).Unlimited number of files can be uploaded to this field.256 MB limit.Allowed types: pdf, doc, docx, odt, ppt, pptx, odp, xls, xlsx, ods. There will be a slight delay while your file is scanned for potential viruses. Please do not refresh or click the back button. IBC Approved Hazardous Communication Signage Upload Include when applicable. File names should not include any characters other than hyphens (-) and underscores (_). There should only be one period (.) in the file name before the file extension (for example, xyz-staff-training4.docx).Unlimited number of files can be uploaded to this field.256 MB limit.Allowed types: pdf, doc, docx, odt, ppt, pptx, odp, xls, xlsx, ods. There will be a slight delay while your file is scanned for potential viruses. Please do not refresh or click the back button. MCW Office of Research (OOR) OnCore Financials exception memo Upload File names should not include any characters other than hyphens (-) and underscores (_). There should only be one period (.) in the file name before the file extension (for example, xyz-staff-training4.docx).Unlimited number of files can be uploaded to this field.256 MB limit.Allowed types: pdf, doc, docx, odt, ppt, pptx, odp, xls, xlsx, ods. There will be a slight delay while your file is scanned for potential viruses. Please do not refresh or click the back button. Other Documentation Upload Include any additional documentation that is applicable to your project. File names should not include any characters other than hyphens (-) and underscores (_). There should only be one period (.) in the file name before the file extension (for example, xyz-documentation5.docx).Unlimited number of files can be uploaded to this field.256 MB limit.Allowed types: pdf, doc, docx, odt, ppt, pptx, odp, xls, xlsx, ods. There will be a slight delay while your file is scanned for potential viruses. Please do not refresh or click the back button. CAPTCHA Save Draft Submit Leave this field blank Contact Us 414-805-4082 Contact Us MCW Office of Research MCW Human Research Operations Committee Office Location Froedtert Hospital Campus 9200 W Wisconsin Ave Milwaukee, WI 53226 Pavilion Building, 3rd floor Research For Researchers (OCRICC) Clinical Research Billing Compliance Requesting Froedtert Health Pricing Research Pricing Request Application Research Chargemaster Requesting OCRICC Administrative Approval Administrative Approval Request Application Operational Feasibility Planning Tool Research Consent Post-Approval Activities Use of Froedtert Health PHI PHI Accounting Log Contact Us Issue Escalation
