Part A TRIA / Part B MIRA Instructions


CCD CLINICAL FORMS

Three forms, internal to the University of Louisville and specifically to the Office of Clinical Contracts Division (CCD), assist in the review and approval of sponsored clinical projects at UofL:

  • Part A TRIA (Transmit for Review and Initial Assessment)
  • Part B MIRA (Multi-Institutional Research Application)
  • Clinical Attachment to the PCF (Proposal Clearance Form)
    (see specific instructions for completing the PCF and the Clinical Attachment)

The forms provide information about sponsored activities that are clinical in nature and/or that use the facilities or resources (including employees) of Jewish Hospital & St. Mary’s HealthCare, Norton Healthcare, UofL Hospital, Owensboro Medical Health System or any other external health-care provider. If any UofL employees serving as principal investigator (PI), multiple principal investigator (MPI), co-investigator (Co-I), key personnel or other are performing activities as part of a sponsored project (e.g., clinical research, clinical trial), the forms and the documents they accompany should be submitted to CCD. For questions or to submit forms, contact:

Clinical Contracts Division
Office of Industry Contracts
MedCenter One, Suite 200
501 E. Broadway
Louisville, KY 40202-1798
Phone 852-8359—Fax: 852-2590
Email

If none of the PIs, MPIs and Co-Is are UofL appointees and no UofL employees are performing activities with the sponsored project or are key personnel, check with the respective employing organization’s research office regarding its submission requirements.

WHEN TO USE EACH FORM

The situations in which these forms should be used are clinical trials and clinical research that are funded directly by industry or nonprofit sponsors.

Please note that requests for duplicate information between the TRIA and MIRA have largely been eliminated. Therefore both forms are needed to capture all the necessary information about a study. The TRIA may be submitted either in advance of or in conjunction with the MIRA. Exception: When a PCF with Clinical Attachment is submitted, a TRIA is not needed.

Part A TRIA
For clinical trials/research sponsored by industry or for-profit entities, use the TRIA to begin the review process.

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Part B MIRA
Submit the MIRA when budget details and other information are finalized.

PCF with Clinical Attachment
For clinical projects funded by governmental or nonprofit entities, use the PCF with Clinical Attachment for review prior to proposal submission.

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Part B MIRA
When the sponsor indicates the proposal is likely to be funded, the MIRA should be submitted.

DEPARTMENTAL APPROVAL

Because the TRIA submission is a preliminary action that allows a negotiator within the Clinical Contracts Division (CCD) to begin reviewing a project, no departmental signature is required on the TRIA form. However, either the MIRA or the PCF with Clinical Attachment must be routed via the department chair and dean’s office for signatures prior to being submitted to CCD for institutional approval.

NOTIFICATION OF CHANGES IN STUDY STATUS

The primary contact/PI and representatives from each affiliated site are asked to notify the other respective groups involved of any changes in study status (e.g., negotiations halted, sponsor cancels, PI withdraws).

NONDISCLOSURE AGREEMENT

Sponsors frequently require signed confidentiality or nondisclosure agreements (CDAs, NDAs) before forwarding protocols and/or contract terms and request that they not be shared with anyone to whom access has not been granted. If you have questions about whether or not you may share such information, contact CCD. The NDA must be negotiated by CCD and signed by the ULRF signatory authority. In order for CCD to review and sign such NDAs on behalf of the university, send NDAs along with the NDA Review Form (found on the website) to the division using our online form.

FACILITY USE AGREEMENT, SERVICES AGREEMENT & SUBCONTRACT

Several sponsors require hospital sites to sign a facility use agreement; most Louisville Medical Center (LMC) hospital sites require ULRF to sign a research services agreement or subcontract. Each LMC hospital site must issue its approval prior to any study being conducted using its facilities. The respective LMC hospital site(s) will respond to CCD, PI and primary contact via email.

Part A TRIA INSTRUCTIONS

    1. Tracking Number. CCD will assign a number to track this project.
    2. Negotiator. CCD will assign a negotiator to this project.
    3. Date. Enter the date of submission of form to CCD.

PROJECT TITLE

    1. Title of Study. Enter the title of the study, starting with the protocol number (if applicable). Use the title listed on the sponsor’s protocol or other documentation if the project is sponsored. Please limit your entry to 254 characters (the limit imposed by PeopleSoft).

PRINCIPAL INVESTIGATOR

    1. Principal Investigator. Identify the Principal Investigator (PI). If there are Multiple PIs on the project, identify the Contact PI. Contact information is necessary for inclusion in the project agreement to be drafted and/or finalized by the negotiator. Department information is necessary for proper crediting within the PeopleSoft system.
      1. Name of the PI
      2. PI’s UofL employee ID number
      3. PI’s university email address
      4. PI’s university telephone and fax numbers
      5. PI’s university street address
      6. PI’s university city, state and ZIP code
      7. ACAP Name. PI’s primary academic appointment (ACAP) or non-academic appointment (NACA) department name
      8. ACAP Number. PI’s primary academic appointment (ACAP) or non-academic appointment (NACA) department number

CHECKLIST

    1. Attachments to this TRIA Submission.Check each attachment you are including with the TRIA form.
      1. Required
        Contract. A draft copy of the sponsor’s contract. Examples of possible contracts are clinical trial agreements, material transfer agreements, and equipment loan agreements. If the sponsor has no contract, check the secondary box to indicate that UofL’s template contract should be used.
      2. Required
        Protocol. A copy of the protocol. Enter the protocol number in the space provided. If no sponsor-provided protocol number is available, enter a short identifier such as a study acronym.
      3. Required
        NDA. If, as allowed by previous policy, a nondisclosure agreement (NDA) were signed by the PI in order to obtain study materials, but not signed by an authorized university signatory, include a copy of the NDA for CCD’s reference. Please note that exclusion of CCD from negotiation and execution of NDAs is no longer advised. If there is no NDA, or if an NDA has been signed by CCD, check the secondary boxes to indicate such. Enter any previous NDA tracking number in Item 10, Previous Related Projects or Agreements.
      4. Recommended
        Budget. A draft copy of the research budget if it is available.
      5. Recommended
        Informed Consent & Research Authorization. A draft copy of the informed consent and HIPAA research authorization form. The draft is expected to precede the final version that the IRB will review. Note that inconsistencies in language or terms between the draft and final versions may delay execution of the study contract.

PERIOD OF PERFORMANCE

    1. Expected Start and End Date of Project.Provide your best estimate as to the planned start and end dates for the study. This helps CCD know the anticipated schedule. (Please note that agreement negotiation and execution must take place before the project can begin as the sponsor may not pay expenses without an agreement, so keep this in mind when selecting a start date). Dates entered at this point are subject to change per the executed agreement or other factors, but PeopleSoft requires tentative dates at time of initial entry.
      1. Required
        Start Date. Enter the date the project is expected to begin. Use the format MM/DD/YY.
      2. Required
        End Date. Enter the date the project is expected to end. Use the format MM/DD/YY.

PRELIMINARY BUDGET INFORMATION

    1. External Funds. Identify the nature of support for the project.
      1. External Funds Expected. Check whether or not funds are expected from a source outside the university. If no, a tracking number with the prefix IOIC (indicating internal) will be assigned to the project. If yes, choose either the prefix OICB (indicating funds will be budgeted into separate categories) or OICN (indicating funds will be nonbudgeted in one lump sum).
      2. Anticipated F&A Rate. If funds are expected, enter the facilities and administrative cost (F&A) rate anticipated or expected to be used. Some sponsors refer to this cost as "indirect" or "overhead." View current UofL rates on the EVPRI website. If the sponsor excludes F&A or offers a rate other than that approved for UofL, attach a copy of the sponsor’s written policy or provide the link to the web site.
      3. Anticipated Total Budget. Provide your best estimate for the total project budget. The amount entered at this point is subject to change per the executed agreement or other factors, but PeopleSoft requires an amount to be entered at time of initial entry.
      4. Department Name. Enter the name of the department that will handle budgetary and financial matters for the project (e.g., will enter requisitions, will have approval for spending).
      5. Department Number. Enter the number of the department that will handle budgetary and financial matters for the project.
      6. Address. If the address to which payments should be sent is different from the PI’s address, enter the street address.
      7. City, State, Zip. If different from the PI’s, enter the city, state and ZIP code for payments.
    2. Support Other Than Monetary.Industry-sponsored activities and all sponsored activities that are clinical in nature must be cleared through the Clinical Contracts Division (CCD) to assure appropriate treatment in the university system. Support for a sponsored project is often provided by funding, but it may also be in a non-monetary form. Check whether any of the following apply to this project.
      1. Disposition of Property. The project involves disposition of property, whether tangible or intangible, that may result from the project (e.g., equipment, records, inventions, copyrights, or rights in data).
      2. Reports or Deliverables. Progress, technical, final reports or other deliverables are required, excluding stewardship reports on gifts.

        The guidelines found in the Definition of Sponsored Activities may also assist in determining which agreements fall into the category of sponsored activities.

PREVIOUS RELATED PROJECTS OR AGREEMENTS

    1. IOIC, OICN, or OICB Number(s) of Related Projects. List any previous projects, such as nondisclosure agreements or preliminary studies, that are directly related to this project. Use the PeopleSoft number(s) beginning with “IOIC,” “OICN” or “OICB.”

SPONSOR

    1. Sponsor. Identify the primary or overall sponsor of the project.
      1. Payer. Check whether this entity will be making payments directly to ULRF for the project.
      2. Name of the organization
      3. The organization’sURL
      4. The organization’s street address
      5. The organization’s city, state and ZIP code

        If this sponsor is a nongovernmental entity, provide the following information for the individual who will be negotiating the contract:
      6. Name of the contract negotiator
      7. The contract negotiator’s title
      8. The contract negotiator’s email address
      9. The contract negotiator’s telephone and fax numbers

      Note that sponsors new to UofL sponsored activities (i.e., those that have never sponsored any UofL projects and that have not been entered into our PeopleSoft vendor and sponsor databases) must complete a New Vendor Survey Form, as well as a W-9. This requirement applies to both primary sponsors and intermediaries.

    2. CRO or Intermediary. Identify the CRO (Clinical/Coordinating Research Organization) or intermediary here.
      1. Payer. Check whether this entity will be making payments directly to ULRF for the project. If no CRO or intermediary is involved with the project, check the box indicating not applicable.
      2. Name of the organization
      3. The organization’s URL
      4. The organization’s street address
      5. The organization’s city, state and ZIP code

        If this sponsor is a non-governmental entity, provide the following information for the individual who will be negotiating the contract:
      6. Name of the contract negotiator
      7. The contract negotiator’s title
      8. The contract negotiator’s email address
      9. The contract negotiator’s telephone and fax numbers

PRIMARY CONTRACTS FOR PROJECT

    1. Clinical Contact. Identify the individual who is the clinical contact on the study, such as the clinical coordinator.
      1. Name of the contact
      2. Contact’s UofL employee ID number
      3. Contact’s title
      4. Contact’s university email address
      5. Contact’s university telephone and fax numbers
    2. Regulatory Contact. Identify the individual who is the regulatory contact on the study. Simply check the box if this individual is also the clinical contact.
      1. Name of the contact
      2. Contact’s UofL employee ID number
      3. Contact’s university email address
      4. Contact’s university telephone and fax numbers
    3. Pre-Award Budget Contact.Identify the individual who is the pre-award (i.e., before the award or agreement is finalized) budget contact on the study. For example, OCRSS might handle the pre-award budgetary aspects, but the PI’s department might handle the post-award financial matters.
      1. Name of the contact
      2. Contact’s UofL employee ID number
      3. Contact’s university email address
      4. Contact’s university telephone and fax numbers
    4. Post-Award Budget Contact.Identify the individual who is the post-award (i.e., after the award or agreement is finalized) budget contact on the study. Simply check the box if this individual is also the pre-award budget contact.
      1. Name of the contact
      2. Contact’s UofL employee ID number
      3. Contact’s university email address
      4. Contact’s university telephone and fax numbers
    5. Other Contact. Identify any other individual who should be copied on correspondence regarding this project.
      1. Name of the contact
      2. Contact’s UofL employee ID number, if applicable
      3. Contact’stitle
      4. Contact’s department (or organization if not an employee of UofL)
      5. Contact’s email address
      6. Contact’s university telephone and fax numbers

PROTECT CHARACTERISTICS

    1. Under FDA “Compassionate Use.” Check whether or not the study falls under the FDA Treatment IND guidelines for “compassionate use.” This term is used to describe a method of providing experimental therapeutics prior to final FDA approval for use in humans. This process typically is used with very sick individuals who have no other treatment options. Often, case-by-case approval must be obtained from the FDA for "compassionate use" of a drug or therapy. Provide a copy of the FDA clearance letter, if applicable.
    2. Drug/Device FDA-Approved for Indication.
      1. Check whether or not the subject drug or device has been approved by the FDA for the subject indication. Check the box for not applicable if no drug or device is involved in the study. For information regarding investigational new drugs, see Center for Drug Evaluation and Research (CDER) at http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm. For investigational new devices, see FDA Device Advice: Comprehensive Regulatory Assistance at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UCM2005299.htm.
      2. Enter the name of the drug or device, if applicable.
    3. FDA Phase. For most industry-sponsored clinical trials, the sponsor will have identified the FDA phase of the study. Note that the FDA phase may differ from the NIH phase. Refer to http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070273.pdf and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070567.pdffor additional information.
      1. Phase I Trials. Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
      2. Phase II Trials. Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks.
        Phase II trials are sometimes divided into phase IIa pilot trials and phase IIb well controlled trials.
      3. Phase III Trials. Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide an adequate basis for physician labeling.
        Phase III trials are sometimes divided into phase IIIa trials, conducted before regulatory submission, and phase IIIb trials, conducted after regulatory submission but before approval.
      4. Phase IV Trials. Post-marketing studies to delineate additional information including the drug's risks, benefits and optimal use, and new indications for the drug.
      5. Not applicable
    4. Funding Source.Check all the categories that apply. In most situations, only one box will be checked; however, it is possible that more than one item is applicable.
      1. Industry
      2. Government
      3. Cooperative group. Cooperative groups are informal and formal networks or groups of individuals or organizations that work together on clinical studies. They may work on common protocols at multiple entities. Examples of cooperative groups are SWOG–SouthWest Oncology Group, PPRU–Pediatric Pharmacology Research Unit network.
      4. Foundation
      5. Not funded
      6. UofL. Internally funded by UofL.
      7. ULH/NHC/JHSMH/OMHS. Funded by University of Louisville Hospital (ULH), Norton Healthcare (NHC), Jewish Hospital & Saint Mary’s Healthcare (JHSMH), or Owensboro Medical Health System (OMHS).
      8. Other. If checked, explain in the space provided.
    5. Multicenter Study. The National Cancer Institute defines a multicenter study as a clinical trial that is carried out at more than one medical institution. Check whether or not the study will be conducted at institutions or organizations other than the University of Louisville. Having a clinical trial agreement with ULRF which has the principal investigator seeing subjects at Norton Healthcare, Jewish Hospital & St. Mary’s HealthCare, University of Louisville Hospital, Owensboro Medical Health System and/or Veterans Affairs Medical Center does not qualify as multicenter.
    6. Author of Protocol.Check all the categories that apply. In most situations, only one box will be checked; however, it is possible that more than one item is applicable.
      1. Investigator
      2. Sponsor
      3. Cooperative group. See 21c above for explanation.
      4. Other. If checked, explain in the space provided.
    7. Initiator of Study.Check all the categories that apply. In most situations, only one box will be checked; however, it is possible that more than one item is applicable.
      1. Investigator
      2. Sponsor
      3. Cooperative group. See 21c above for explanation.
      4. Other. If checked, explain in the space provided.
    8. Type of Study.Check all the categories that apply. In most situations, only one box will be checked; however, it is possible that more than one item is applicable.
      1. Drug study
      2. Device study(Provide the FDA clearance letter, if applicable.)
        1. Premarket Application PMA)
        2. Premarket Notification 510(k)
      3. Chart review
      4. Observational study
      5. Specimen study
      6. Registry of data or information
      7. Repository of physical tissue or biological samples
      8. Other. If checked, explain in the space provided.
    9. Transfer of Biological/Chemical Materials. Indicate if human and/or non-human materials or other biological/chemical materials are being received by the university from another entity or if we are sending such from the university to another entity.

COMPLIANCE COMMITTEES

    1. UofL Participant(s) Will Be Directly Involved.Identify any of the following areas in which UofL participants will be directly involved. For any choice checked, also provide the review or approval number as assigned by the compliance committee, as well as the approval date. If approval has not yet been issued, enter “Pending” in the space provided. Note: The PI is responsible for complying with university safety rules, policies and procedures. Documentation of institutional approval for actions pending at the time of proposal must be provided prior to activation of award (or prior to human subject enrollment in cases of industry-sponsored projects).
      1. Humans as subjects (see http://louisville.edu/research/humansubjects for additional information)
      2. Experimental animals (see http://louisville.edu/research/iacuc)
      3. Radioisotopes (see https://louisville.edu/dehs/)
      4. Recombinant DNA (see https://louisville.edu/dehs/)
      5. Pathogenic organisms (see https://louisville.edu/dehs/)
      6. CDC or USDA select agents (see https://louisville.edu/dehs/)
      7. Human blood, tissues, cell lines, OPIM (see https://louisville.edu/dehs/)
      8. Highly toxic, carcinogenic, mutagenic agents (see https://louisville.edu/dehs/)

ANCILLARY CONTRACTS

    1. Ancillary To Be Issued. List any ancillary contracts needed, such as procurement contracts to organizations that will provide services and/or receive payments from ULRF for this project. (Note: Include cumulative costs for all contracts in the overall budget for the project.) Attach a statement of work for each contractor. Provide the consultant’s or organization’s name as well as contact information in order for CCD to discuss and negotiate any contract that may be needed. Use additional sheets if more than three contractors need to be listed. Be sure to contact the UofL Purchasing department for consulting agreement requirements, which are handled differently from contracts, prior to starting the project. See Purchasing's Personal Service Contracts web site for more information on this.

SITE FACILITIES AND RESOURCES

    1. Study Sites. Indicate the entities at which subjects will be seen, facilities will be used or resources will be used or provided. While you do not want to check locations you won’t use, you should include those with a reasonable likelihood of being used where subjects for the study will be enrolled. Except for the UofL facilities (first site), these entities are considered “third parties” with regard to contracting, which means additional contractual arrangements and/or approvals must be made to bring them into the project. Remember that approval by each facility/site is required in addition to university approval and contract execution.
      For each facility/site to be used, check all applicable areas of involvement:

      1. Places—Facility/Department Use. Project (or a portion of it) will be performed within the facility. Specific departments within the facility will be engaged in providing services for the project, performed by either UofL personnel or facility personnel. Check each applicable department. The options are blood bank, cath lab, laboratory, nutrition, pathology, pharmacy, physical therapy, radiology, respiratory therapy and other (please identify in the space provided). If the facility is providing SPACE only, please select “Other” and so state.
      2. Information—Confidential Information. Facility personnel will have access to sponsor’s confidential information, such as the protocol.
      3. People—Perform Research Services. Facility personnel will perform research services pertaining to the project. Please indicate for RESEARCH services only (as opposed to conventional care or in addition to conventional care). Contact the specific facilities involved for their pricing on research.
      4. Items—Equipment/Drug/Device. Any drug, device, equipment, compounds, software or other resources—which have been provided or loaned by the sponsor—will be used or housed in the facility. Note that provision of any such resource in lieu of funding means the project is a sponsored activity and subject to university review and authorization, just as a funded project would be.
        1. UofL Facilities. Provide building names and room numbers.
          Space owned or leased by UofL at Health Sciences Center (HSC), Belknap Campus, Shelby Campus, UofL Clinics, and Cardinal Research Cluster (CRC)
        2. University of Louisville Hospital (ULH)—Part of KentuckyHealthOne—CIRI
          UofL Hospital (Concentrated Care Building or CCB), James Graham Brown Cancer Center (BCC), ULH space in or services performed within the UofL Health Care Outpatient Center (HCOC), or any other ULH facility (enter the name and address of the facility in the space provided)
        3. Jewish Hospital & St. Mary’s Healthcare—Part of KentuckyHealthOne—CIRI
          Frazier Rehab Institute, Jewish Hospital, Jewish Hospital Medical Center East, Jewish Hospital Medical Center Northeast, Jewish Hospital Medical Center South, Jewish Hospital Medical Center Southwest, Jewish Hospital Outpatient Center, Jewish Hospital Rudd Heart and Lung Center, Jewish Hospital Shelbyville, Our Lady of Peace Hospital, Saints Mary & Elizabeth Hospital, St. Mary’s Surgery Center, Health Resource Center, Southern Indiana Rehab Hospital, Taylor Regional Hospital, VNA Nazareth Home Care, Jewish Hospital Health Center—Meade County, Jewish Hospital Hand Care Center, or any other JHSMH facility (enter the name and address of the facility in the space provided)
        4. Norton Healthcare Facilities
          Norton Hospital, Norton Children's Hospital, Norton Audubon Hospital, Norton Brownsboro Hospital, Norton Women's and Children's Hospital—St. Matthews, Norton Children's Medical Center—Brownsboro, Norton Medical Plaza—Brownsboro, space leased by UofL in a Norton Healthcare facility, Norton Physician Practices, or any other NHC facility (enter the name and address of the facility in the space provided)
        5. Owensboro Medical HealthSystem. Enter the name and address of the facility in the space provided.
        6. Veterans Affairs Medical Center. Note that projects utilizing VA facilities or resources will require a separate submission to the VA. Enter the name and address of the facility in the space provided.
        7. Private Practice or Professional Service Corporation (PSC). This includes those located within the UofL Health Care Outpatient Center (HCOC). Enter the name and address of the group in the space provided.
        8. Other. Enter the name, contact information and address of the site in the space provided.

      Part B MIRA INSTRUCTIONS

        • 1. Tracking Number. Indicate if a TRIA, PCF or no preliminary form has already been submitted for this project, and enter the tracking number if applicable. Otherwise CCD will assign a number upon submission of this form.
        • 2. Negotiator. Enter the negotiator already assigned to this project. If no assignment has yet been made, CCD will assign a negotiator upon submission of the form.
        • 3. Date. Enter the date of submission of form to CCD.

      PROJECT TITLE

        • 4. Title of Study. Enter the study’s title. Use the title listed on the sponsor’s protocol or other documentation if the project is sponsored. Please limit your entry to 254 characters (the limit imposed by PeopleSoft).
        • 5. Protocol or Award Number. Enter the protocol number or award number as provided by the sponsor.

      PRINCIPAL INVESTIGATOR

        • 6. Principal Investigator. Enter the name of the Principal Investigator (PI). If there are Multiple PIs on the project, identify the Contact PI.

      CLINICAL TRIALS WEBSITE

        • 7. ClinicalTrials.gov Registration. If the study has been registered, enter the registration number assigned by ClinicalTrials.gov via the web-based data entry system called Protocol Registration System (PRS). Check the box if registration on ClinicalTrials.gov is not applicable. See the CCD web site for additional information about getting started in and registering studies on ClinicalTrials.gov.

      KEYWORDS

        • 8. Keywords. Enter keywords appropriate for research interests related specifically to this project. These keywords identify faculty research areas in order to match them to requests for information and for distributing extramural funding opportunities.

      PROJECT TYPES

        • 9. Purpose Code. CCD must enter a brief description of the purpose of each project into PeopleSoft. Choose one purpose code that best describes this project.
            • a. Clinical Research (CLR)
              Study involves human subjects but without medical or clinical intervention, and is therefore not a “clinical trial” by definition (see below); examples: observational/specimen study, chart review, survey research
            • b. Clinical Trial (CTA)
              Study in which human subjects are assigned to a group that receives a clinical/medical intervention (e.g., medication, clinical/medical procedure, device) and/or a control group for a clinical condition and who interact with study personnel, having provided an informed consent
                • Clinical condition–symptom, set of symptoms or a diagnosis as determined by a qualified investigator
                • Note: Consenting to the use of a biological fluid or tissue sample only for subsequent study does not constitute a clinical trial as there is no ongoing interaction between the investigator/study personnel and the human subject

              What is the definition of clinical trial for purposes of proposal submission

            • c. Clinical Trial Research (CTR)
              Clinical trial but set up to report time and effort/budget categories (as for federal grants, in which case purpose code is entered as CTR rather than RES). If the project has both fixed and per-patient costs, the CCDB portion is coded as CTR and the CCDN portion as CTA
            • d. Unfunded Collaborative Research (CRES)
              Collaborative research in which no funds are exchanged between university and sponsor (although equipment/material transfer or sponsor personnel may be involved)
            • e.Research (RES)
              Default purpose code for sponsored activity involving research (other than clinical in nature, unfunded collaborative, service, training or other)
            • f. Service (SERV)
              Sponsored activity involving UofL service mission; public service (not to be confused with a services agreement wherein sponsor-specified goods or services are provided to the sponsor)
            • g. Training/Education (TRNED)
              Sponsored activity providing education or training to sponsor (e.g., seminars) or meeting a need for training/educating individuals to fulfill community or national need
            • h. Other Sponsored Activity
              Used only if no other purpose code is applicable; enter a brief description in the space provided
        • 10. Agreement Type. FOR COMPLETION BY CCD.The assigned CCD negotiator will determine the agreement type to be entered into PeopleSoft and other tracking systems.

      FIELD OF SCIENCE

        • 11. Field of Science. Please identify the field of science category closest to your efforts on this project. If your area is not specifically listed, under the closest major category please provide a brief description in the space provided. (See additional guidance.)

      UNIVERSITY RESOURCES

        • 12. University Resources. The department chair and dean (or designee) must initial and date each request below to signify approval of the specific resource.
            • a. Faculty Release from Work Plan Responsibilities
              Faculty release time occurs when an appropriate percentage of time is not available according to the annual workload agreement.
            • b. Faculty SalaryRecovery
              Salary recovery occurs when any portion of a faculty member’s university-sponsored institutional base salary is to be paid by the sponsor.
            • c. Supplemental Base or Approved Additional Non-BasePay
              Approved additional non-base pay (formerly known as “x-pay”) is considered only on an exceptional basis. The faculty member must sign a statement indicating that the effort on the grant plus any outside work does not exceed an average of one day per week paid by UofL as permitted under Section 4.3.3 of the Redbook. If the effort exceeds the “one day per week” rule, salary release to compensate the university must be recovered.
            • d. Sponsor-Required CostShare
              Check “yes” if sponsor requires cost share or matching funds. Fill in details in budget section.
            • e. University Commitments after Extramural Support isTerminated
              The unit dean should provide notification to central administration if such commitments will require collaboration between units or support from central administration.
            • f. New Credit Courses, Degree Programs, Centers orInstitutes
              The PI should follow up with the unit dean to assure that the new courses, degree programs, centers or institutes are appropriate and will be implemented to fulfill the obligations of the resulting award/contract.
            • g. Additional Space orFacilities
              The unit dean is asked to approve a plan for the need for additional space or facilities to provide information for overall planning. Please follow up with your unit to ensure that the required activities will be available or completed by the anticipated time of award.
            • h. Facility Modification
              The unit dean must approve a plan for any of these activities (installation, equipment maintenance, space renovation, building modification) to provide information for overall institutional planning. Please follow up with your unit to ensure that the required space or facilities will be available by the anticipated time of award.
            • i. Other Special Requirements of Department andUnit
              The unit dean should consider what might be needed and be sure to provide pertinent information to others affected. Include a list of the special requirements.
            • j. Major Equipment
              Equipment, technology systems and capital construction which exceed $200,000 require authorization in the state budget before they can be acquired or construction started. You should submit plans for such items through your unit’s capital construction/major equipment planning process so that they can be included for state budget authorization. Include the contact person and phone number in the spaces provided.

      BUDGET

      When completing the budget section, please include dates and amounts for the entire period of the project (unless otherwise directed by the sponsor). As a result it will not be necessary to complete a new MIRA each year of the funded project. Once the PI(s), chair(s), and appropriate dean(s) and/or unit head(s) approve the initial project, their approvals are not necessary for subsequent years unless changes to budget, percent effort, personnel, etc. are later required.

        • 13. Location of Majority of UofL Performance. Please indicate the location where more than 50% of UofL’s portion of work on the project will be performed (that is, the place where UofL personnel will be conducting their work and research). When determining the primary location, do not include any work performed by subcontractors or personnel external to UofL. If more than 50% of a project is performed off-campus by UofL personnel, the off-campus rate will apply to the entire project. Grants or contracts will not be subject to more than one facilities & administrative (F&A) cost rate. See Facilities & Administrative Cost (F&A) (a.k.a. Indirect Cost) Rates for additional information.
            • a. Belknap Campus. On-campus F&A rate will be assessed.
            • b. Health Sciences Center (only UofL-owned/leased space). On-campus F&A rate will be assessed.
            • c. Shelby Campus. On-campus F&A rate will be assessed.
            • d. Off Campus (including hospitals and practice groups) if work is performed by UofL personnel. Off-campus F&A rate will be assessed.
        • 14. Department ID for Budgeting/Expending Purposes. Enter the number of the department that will handle budgetary and financial matters for the project (e.g., will enter requisitions, will have approval for spending).
        • 15. Entire Budget Period.
            • a. Start Date. This date should be derived after agreement negotiations are complete.
            • b. End Date. This date, which is the end date for the entire project, should be derived after agreement negotiations are complete.
        • 16. Entire Budget
          See full explanation of F&A costs and related budget issues at Facilities & Administrative Cost (F&A) (a.k.a. Indirect Cost) Rates. Note that for projects in which the TDC F&A calculation is used, only amounts for TDC, F&A and total project costs are required unless sponsor limits spending to budget categories or requires approval for variances from proposed budget.
            • a. Costs from Sponsor.Budget categories (first eight lines in Column a) should include all direct cost amounts requested from the sponsor. Provide amounts for the following budget pool categories as applicable:
          Salary & Wages (511000)
          Fringe Benefits (512000)
          Equipment ≥$5K per item (190000)—List equipment costing less than $5,000 per item under Supplies & Expense.
          Alteration/Renovation ≥$100K (190000)—Cost revisions which cause budget to fall below $100K threshold per project (e.g., final cost is only $99K, or two separate renovation projects total $50K each) will disqualify project as a capitalized expense and will incur F&A when spent.
          Subcontracts (519000)—List the cumulative amount for all subcontracts on this Subcontracts line; identify subcontracts individually in Part A TRIA Item 28. Be sure to contact the UofL Purchasing department for consulting agreement requirements, which are handled differently from subcontracts, prior to starting the project. See Purchasing's Personal Service Contrats web site for additional information.
          Supplies & Expense (519000)
          Travel (535000)
          Tuition (520000)
          Total Direct Costs. Add the amounts identified above in the first eight lines of Column a. The sum of these categorized amounts is the total direct cost (TDC) base.
            • b. Exclusions to TDC Base.List any direct costs that have been included in the amounts in Column a that are not subject to F&A charges. Note the following specific considerations:

              Subawards. The first $25,000 of each subaward is subject to F&A, but amounts in excess of $25,000 for each subaward are excluded from F&A.
              Patient Care. Costs for routine and ancillary services provided by hospitals to individuals participating in research programs are excluded from F&A. This does not include research costs such as patient travel or subsistence, or consulting physician fees. See http://grants.nih.gov/grants/policy/nihgps_2011/nihgps_ch19.htm?print=yes& for additional information.
              Total Exclusions. Add the amounts identified above in Column b to show total exclusions.

            • c. UofL Cost Share. Cost sharing must be identified if: Sponsor requires specific university matching; time and effort of university personnel on the project is not allowed by the sponsor; salary being requested is not equivalent to committed effort; university cost sharing is committed in the narrative of the proposal. Include foregone F&A that would otherwise have been recovered had the direct cost amounts not been cost shared. The PI must provide justification for all cost sharing identified in the proposal. Indicate the speedtype from which each cost share category will be paid.

              NOTE: Due to federal rules all committed cost sharing identified in the proposal to the sponsor must be separately budgeted and accounted for. Non-mandatory cost sharing should not be committed.

              Budget categories should include amounts of in-kind or new funds needed for the project. The source of these funds must be identified by speedtype number. In-kind funds are those already available for the project. New funds are new dollars from UofL sources not currently available, but approved for this project. Cost sharing guidelines are available in the UofL policy library. The university's policy concerning tuition remission for GRA on grants and contracts is available on the Vice President for Finance website at http://louisville.edu/vpf/budget/policies/index.html#TuitionRemissionGraduateAsstship. If there is a third-party cost share, please enter name of entity, type of cost sharing, and amount in budget remarks section. Also, submit with the MIRA written confirmation of the agreement FROM the third party. ANY COST SHARING MUST BE APPROVED IN WRITING BY THE APPROPRIATE UNIVERSITY OFFICIAL PRIOR TO THE SUBMISSION TO THE OUTSIDE AGENCY.
            • d. F&A Calculations

              Direct Cost Base. Subtract the sum of the exclusions (Column b) from the total direct costs (Column a). The result is the direct cost base on which F&A will be charged. Note: Under Column c, enter the total of any cost share amounts as well as any foregone F&A.
              F&A Rate. Enter the F&A rate applicable to this project.
              F&A Costs. As applicable, multiply either the TDC base (Column a) or Modified TDC base (Column a less exclusions in Column b) by the F&A rate to show the amount of F&A costs. Note: Typically only certain nonfederal projects (e.g., non-federal clinical trials, KSTC/KSEF proposals, or any project using less than the full F&A rate) are eligible to use the TDC base in calculating F&A.
            • e. Total Amount
              Total Cost of Project.
              Add the TDC base from Column a and the F&A amount to show the project’s total cost. Provide a separate total for any cost-shared amount.
        • 17. Budget Remarks. Please comment on any cost share or third-party match, on any nonstandard F&A items, on any direct cost items typically unallowable based on our federally negotiated rate agreement, and on any budget item requiring explanation or justification.

      SIGNATURE PAGE

          • 18. Responsible Signatory. Each principal investigator, co-investigator, faculty member, key personnel, other participant, department chair (or appropriate unit head), and unit dean (or appropriate unit head) must sign. Investigators receiving RIF are asked to sign on the page provided (and on initial additional signature pages if necessary) in order to keep RIF amounts together. Additional signature lines are available on a separate page (PCF/MIRA Additional Signature Page). Each signatory must be aware of what they are signing and of their individual level of responsibility.

            NOTE: Each signatory must check the box acknowledging compliance with conflict of interest regulations. For more information or to complete an Attestation and Disclosure Form (ADF), please see the Research Integrity Program webpage.