Frequently Asked Questions
Agreements and Approvals
What does the Research Contracts unit require for each agreement?
Confidential Information
Early Termination
If a study is terminated early, what are the Sponsor's obligations?
E-transmission
Forms and Signatures
A sponsor sent me an amendment just to extend the time and budget. Can I just sign it?
A sponsor gave me a W-9 form to fill out. What do I do with it?
Industry-sponsored Clinical Trials
Who is handling negotiations for industry-sponsored clinical trials?
Who do I contact to follow up on an industry-sponsored clinical trial document?
Answers
Agreements and Approvals
What does the Research Contracts unit require for each agreement?
Various forms and documents will be needed before an agreement will be executed. You are now asked to include the checklist when you send in the agreement for negotiation. This page contains information on attachments needed for each type of agreement.
I am planning a clinical study at Regional One Health that is funded by departmental funds. What institutional approvals are necessary?
All human subject studies must be approved by the IRB. All studies at Regional One Health must have their institutional approval. The contact at Regional One Health is Maria van Werkhooven. All externally funded studies must be routed through UTHSC Research Administration.
Confidential Information
With whom may confidential information of a sponsor be shared? If I'm working with a hospital or practice group, is it okay to share information with that entity?
The Investigator is responsible for carefully reading the agreement and complying with all of its terms, including the confidentiality section (which may be in a confidentiality agreement and/or in a clinical study agreement). The University is the contracting party and generally agrees to keep certain information (identified in the agreement) confidential and to disclose it only to its employees who have a need to know for the purposes of the agreement/study and to designated third parties ONLY with the sponsor's prior written permission. So, confidential information provided to the University by the sponsor or as otherwise defined in the agreement cannot be shared with third parties (including hospitals, practice groups, or other non-UT personnel) unless the specific permission is granted by the sponsor.
Early Termination
If a study is terminated early, what are the Sponsor's obligations?
Both parties are obligated to follow the terms of the agreement, and the agreement 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 (consistent with contract language); and (3) any required amounts negotiated between the parties in order to manage study subject withdrawal from the Study, if applicable. The sponsor's other obligations for indemnification, etc. will survive the early termination in accordance with the contract's terms.
E-transmission
If e-transmission of study data is a component of the research study, what issues need to addressed prior to study commencement?
(1) Confirmation, in writing, from the IT area at the site that the site's data transmission lines meet the specifications required by the protocol and the contract's e-transmission section and have been approved by both UT and the Sponsor. The Sponsor/CRO should also be able to provide documentation that they certify or represent that the system of encryption and e-transmission utilized in the research study meet regulatory requirements for such data transmission. (2) Documentation that all study personnel are trained in e-transmission requirements. (3) Documentation of system and software training and validation if computer equipment provided by Sponsor/CRO is to be utilized in the Study.
Forms and Signatures
A sponsor sent me an amendment just to extend the time and budget. Can I just sign it?
The Principal Investigator should not sign any agreements including trial agreements, confidentiality agreements, and amendments. This original agreement was between UT and the sponsor. Always put in Pams and let Trent Pitts know that it is ready for review.
A sponsor gave me a W-9 form to fill out. What do I do with it?
We keep completed W-9 forms in the office which are signed by the appropriate university signatory. Send us an email or call (901) 448-3303. We can send the sponsor that form or handle any other tax forms for the industry sponsored agreements we negotiate. No route sheet or certification page is required for tax forms.
Industry-sponsored Clinical Trials
Who is handling negotiations for industry-sponsored clinical trials?
Associate Director is handling negotiations.
Who do I contact to follow up on an industry-sponsored clinical trial document?
Please contact Ruthie Ruston at (901) 448-3126 to inquire about the status of these documents. She will coordinate with the Associate Director to determine the status and provide a response. Please provide the name of the PI, name of the coordinator, name of the sponsor and/or CRO, and protocol designator.