Frequently Asked Questions

What does the Research Contracts unit require for each agreement?

You will be asked to include the checklist when you send in the agreement for negotiation. Here is information on attachments needed for each type of agreement.

I am planning a clinical study at Regional One Health that is  departmentally funded. What institutional approvals do I need?

All human subject studies must be approved by the IRB. All studies at Regional One Health must have their institutional approval (contact  Maria van Werkhooven at Regional One). All externally funded studies must be routed through the OSP.

Can I share confidential information about a sponsor? If I'm working with a hospital or practice group, is it okay to share information with them?

Carefully read the agreement and comply with all of its terms, including the confidentiality section.

As the contracting party, the university agrees to keep certain information confidential and only disclose it to  employees who have a need to know, and to designated third parties ONLY with the sponsor's written permission. Confidential information cannot be shared with third parties (including hospitals, practice groups, or other non-UT personnel) unless  specific permission is granted by the sponsor.

If a study is terminated early, what are the sponsor's obligations?

Both parties are obligated to follow the terms of the agreement, which generally stipulates each party's obligations in case of early termination. Generally, the sponsor must pay for (1)any amounts earned prior to termination; (2) any nonrefundable costs already incurred; and (3) any required amounts negotiated between the parties in order to manage study subject withdrawal. The sponsor's other obligations will survive the early termination in accordance with the contract's terms.

What do I need to be aware of if my study involves e-transmission of study data?

(1) Provide written confirmation from the IT department at the site, verifying that the site's data transmission lines comply with the specifications outlined in both the protocol and the e-transmission section of the contact. This confirmation should also indicate that both UT and the sponsor have approved these transmission lines. Additionally, the Sponsor or Contract Research Organization (CRO) should supply documentation certifying that the encryption and e-transmission systems used in the research study meet all relevant regulatory requirements for data transmission. (2) Provide documentation that all study personnel are trained in e-transmission requirements. (3) Provide documentation of system and software training and validation if computer equipment provided by sponsor/CRO is to be used in the study.

A sponsor sent me an amendment just to extend the time and budget. Can I just sign it?

Do not sign any amendments on your own. The original agreement was between UT and the sponsor. Notify  Trent Pitts in OSP of any amendments.

A sponsor gave me a W-9 form to fill out. What do I do with it?

W-9 forms should always be signed by the appropriate university signatory.  Call or email the OSP (901.448.3303) so they can send the completed form to the  sponsor.

Who handles negotiations for industry-sponsored clinical trials?

The Associate Director handles negotiations.

Who do I contact to follow up on an industry-sponsored clinical trial document?

Contact Ruthie Ruston at 901.448.3126. Please provide the name of the PI, name of the coordinator, name of the sponsor and/or CRO, and protocol designator.