Start Up Information

Contact

CDA and Accelerated Agreements

Feasibility/Planning Process

Concurrent processes

Budgeting

IRB

Contracting

Contact

The CTU has one point of contact for the first phase of start up:

Karen James

Start up Coordinator

ctu@louisville.edu

502.852.2902

Additional team members are assigned as we progress through the start up process. The information will be available upon official notification of Site Selection.

CDA and Accelerated Agreements

The University of Louisville participates in the Accelerated Research Agreement Initiative. We have an approved CDA and CTA that can be signed with very few modifications http://louisville.edu/research/ccd/forms/acta-uofl

Please notify us if you would like to utilize these documents.

Feasibility/Planning Process

The CTU has a formal feasibility process that takes place when all the necessary documents have been received:

Notification of official site selection

- Final Protocol

- ICF template

- Budget template

- CTA

 We also require through email that the sponsor complete a questionnaire to help us understand the expectations of the sponsor and the contracting requirements of the study following site selection. We have our feasibility/planning evaluation following the receipt of the questionnaire.

Concurrent processes

Once the feasibility/planning evaluation is complete and the Principal Investigator and CTU decide to move forward with the project, all processes (IRB, Budgeting, Contracting, Hospital/Clinic Approval) move forward concurrently.

Budgeting

CTU has standard fees associated with clinical research administration. For details on fees http://louisville.edu/research/ctu/services/fees

IRB

The University of Louisville allows the use of certain central IRBs as well as local IRB. The fee is $3,900 for local oversight ceding to central IRB or local review.  Currently, the IRBs that can be utilized are:

- University of Louisville IRB

- WIRB

- Advarra

- Copernicus

 Our local IRB turnaround time is approximately 21 days following submission. There is a two-week submission deadline for each review. See the all IRB information http://louisville.edu/research/humansubjects

Federal wide assurance

https://louisville.edu/research/humansubjects/about-the-irb/federal-wide-assurance-fwa

Rosters

https://louisville.edu/research/humansubjects/about-the-irb/past-committee-rosters

OHRP and FDA registrations

https://louisville.edu/research/humansubjects/about-the-irb/ohrp-fda

IRB calendar

https://louisville.edu/research/humansubjects/2019CombinedIRBmeetingfinal121318cllrev.pdf

While we can utilize central IRBs, we prefer local IRB oversight due to the ease of reporting and communications among our hospital partners.

Contracting

The contracting process at the University of Louisville can include private clinics and separate hospital entities depending on the needs of the project. We have the following estimated timelines:

- Outpatient study agreements – 30 to 90 days

- Inpatient study agreements – 60 to 120 days

Detailed Information on Contracting

Contracting party

The University of Louisville Research Foundation, Inc. (ULRF) is the legal entity which executes sponsored research agreements for the University of Louisville. ULRF is a limited agent for the University for the purpose of receiving grants and research agreements from external funding sources.

Hospital/Facility Sites

University researchers typically conduct clinical trials at one or more of the following hospital/facilities: Norton Healthcare, Jewish Hospital, University of Louisville Hospital/James Graham Brown Cancer Center, University of Louisville Physicians, Inc. and the Department of Veteran’s Administration Medical Center. Each of these facilities, while affiliated with the University and permit research to be conducted at their facilities by University researchers, is a separate legal entity. The University obtains the appropriate approvals from the respective sites before subject enrollment is permitted.

Facilities & Administration Charges

The Facilities and Administrative charge for industry-sponsored clinical trials is 30%. All expenditures/expenses of the study are subject to these charges.