Forms
Clinical Contracts Division (CCD) provides forms and templates to facilitate contracting with sponsors for research.
NDA Request Form - Nondisclosure Agreement
Purpose: The iRIS NDA Negotiation Request Form captures basic information needed to negotiate a nondisclosure or confidentiality agreement (NDA or CDA).
Submit: Log onto iRIS and submit an NDA Negotiation Request Form, along with an electronic copy of the other party's template NDA. If the other party has not provided a template agreement, the contract specialist will use the Accelerated Confidential Disclosure Agreement (ACDA) for industry sponsored clinical trials or the University of Louisville Research Foundation, Inc template as applicable.
Timeline: A contract specialist will respond within three business days of receipt of your request. Most NDAs are executed within 30 calendar days of request.
Part A TRIA - Transmit For Review and Initial Assessment
Purpose: The Part A TRIA Form captures initial information needed to begin contract negotiations for industry-sponsored clinical research, including clinical trials, clinical data registries and tissue repositories. It applies to projects performed at the University of Louisville as well as at local hospital systems (University of Louisville Hospital, Jewish Hospital and St. Mary’s Healthcare, Norton Healthcare) and other health-care providers.
Submit: Complete this fillable Word form and send it, along with a copy of the protocol and an electronic copy of the sponsor's template clinical agreement, to CCD. If the other party has not provided a template agreement, CCD will use the Clinical Trial Agreement ULRF template. If applicable and available, please also send a copy of the draft budget and Informed Consent & Research Authorization (HIPAA) Form.
Timeline: CCD will respond within three business days of receipt of your submission.
Part B MIRA - Multi Institutional Research Application
Purpose: The Part B MIRA Form details additional information needed for execution of an industry-sponsored clinical research agreement. Signatures on the MIRA certify that each member of the research staff is aware of his duties related to the study, the principal investigator (PI) acknowledges her responsibilities, and the department chair or dean agrees to commit departmental resources to the study.
Submit: Complete this fillable Word form and have it signed by all members of the research staff (including the PI and all co-investigators) as well as by the chair(s) of any department(s) involved. Note that some departments require division chief signature, and that dean or unit head signature is needed when the department chair is also a member of the research staff. Send the signed form to CCD.
Timeline: CCD will respond within three business days of receipt of your submission.
Additional Signature Page: The MIRA provides space for three research staff signatures. This sheet provides space for three additional signatures and can be copied as many times as needed to accommodate all research staff signatures.
Proposal Clearance Form (PCF) and Clinical Attachment
Purpose: The PCF captures information needed for official university review of research proposals. The clinical attachment provides additional details and information related to the clinical components of proposed projects. Signatures on the PCF certify that each member of the research staff is aware of her duties related to the study, the principal investigator (PI) acknowledges his responsibilities, and the department chair or dean agrees to commit departmental resources to the study.
Additional Signature Page: The PCF provides space for two research staff signatures. This sheet provides space for three additional signatures and can be copied as many times as needed to accommodate all research staff signatures.
Submit: Complete these fillable Word forms and have the PCF signed by all members of the research staff (including the PI and all co-investigators) as well as by the chair(s) of any department(s) involved. Note that some departments require division chief signature, and that dean or unit head signature is needed when the department chair is also a member of the research staff. Include all proposal/application documents. Please submit at least five business days before sponsor’s submission deadline.
- For clinical proposals to be submitted directly to the federal government, send the signed form, clinical attachment and proposal to Sponsored Programs Administration (SPA). This applies to projects performed at the University of Louisville as well as at affiliated hospitals or other sites.
- For clinical proposals to be submitted directly to industry and nonprofit sponsors, even if primary funding is federal, send the signed form, clinical attachment and proposal to Clinical Contracts Division (CCD). This applies to projects performed at the University of Louisville as well as at affiliated hospitals or other sites.
Timeline: CCD and SPA need a minimum of five business days to appropriately review proposals for compliance to applicable policies and regulations. CCD will respond within one business day of receipt of your proposal.
Clinical Attachment Instructions
IBED - Investigator, Budget, and End Date Revision Form
Purpose: The IBED Revision Form captures information needed to revise existing chartfields (accounts) within the university’s financial and tracking systems. Signatures on the IBED provide acknowledgment of the PI’s and department head’s approval. Such approval is necessary in order to revise a chartfield or to commit resources to a project beyond those committed previously (via PCF or MIRA). CCD staff can determine if an amendment to the agreement is needed or if revisions fall within existing agreement terms and conditions.
Note: Revisions to budgets, investigators, project end dates, and any other changes no longer require submission of a formal IBED Form. Modifications to these elements of a clinical project can be requested by submission of an email to CCD with a copy (cc) to the PI and appropriate departmental authority/representative.
Submit: Complete this fillable Excel form, have it signed by PI and department head, and send it to CCD. Email requests on which PI and department head are copied may be submitted in lieu of the IBED Form.
Timeline: Most chartfield revisions (apart from amendments) are processed within five business days of receipt of request.
Guarantee/Preaward Spending Request Form
Purpose: The Guarantee/Preaward Spending Chartfield and Speedtype Request Form authorizes the establishment of a project budget in the university financial system—enabling work on a project to begin—in advance of an award. The form identifies the preaward time period, detailed budget, and departmental guarantee account(s) to cover expenses in the event the award is not funded by the sponsor. Signatures on the form provide approval by the guarantee account representative, PI and department head to establish a preaward chartfield.
Submit: Complete this fillable Word form and have it signed by the guarantee account representative, PI and department chair. Note that some departments require division chief signature, and that dean or unit head signature is needed when the department chair is also a member of the research staff. Submit to CCD.
Timeline: Most guarantee preawards are processed within five business days of receipt of request.