Clinical Trial Contracts

Getting Started

Who can help me with industry-sponsored clinical trials?

Your department administrator and the UNeHealth Contracts Office Associate should be notified as soon as you identify a study in which you plan to participate.

Web: unmc.edu/spa/clinical-trials/unehealth
Phone: 402-559-7614
Email: amanda.leingang@unmc.edu

What does UNeHealth require prior to reviewing the contract for a clinical trial and device studies?

Prior to contract review, UNeHealth requires:

All four items should be attached to a single email and sent to the UNeHealth Contracts Office Associate.

Who negotiates the contract?

UNeHealth was developed to centralize contract negotiations for industry-sponsored clinical trials. Contract negotiations, budget negotiations, and regulatory review should occur at the same time to hasten start up, as follows:

When both the contract and budget are finalized, they form the final contract that is signed by all parties to the agreement (i.e., sponsor, UNMC, UNeHealth).

Who signs the contract?

The parties named in the contract are the signatories. UNeHealth coordinates the signature process. Signatures always include a UNMC institutional official and will include the sponsor, as well as a UNeHealth signatory if UNeHealth is a party to the agreement. The PI will sign as to read and acknowledge the terms but is not a party to the contract.

The Principal Investigator does not have signature authority at UNMC to contract terms.

If a sponsor requires a Confidential Disclosure Agreement (CDA) prior to releasing their protocol and negotiating a study agreement, is it OK to sign?

UneHealth should be contacted and will review, negotiate and obtain the proper institutional signature for execution of the CDA. Forward the CDA request and template to the UNeHealth Contracts Office Associate for handling. For more information:

Web: unmc.edu/spa/clinical-trials/unehealth/contact
Phone: 402-559-7614

Finalizing Industry-funded Awards

Clinical trial awards are set up only after final IRB release, which occurs only after the fully-executed contract is received from the sponsor. As soon as UNeHealth receives the signed agreement, the IRB is notified so the IRB protocol can be released when all matters are in order.

IRB release requires that the IRB has approved the protocol and there are no outstanding issues needing review.

Upon IRB release, UNeHealth prepares the award, SPAccounting sets up an account in UNMC’s accounting system and the PI and department administrator are notified by email that the project “bundle” is available in ADIS. The bundle includes:

Defining Roles and Responsibilities for Initiation of Research

Effective management of industry-sponsored projects is a collaborative effort among principal investigators, department administrators, clinical research coordinators, UNeHealth, and Sponsored Programs Accounting.

Principal investigators

Departmental personnel (administrators and clinical coordinators if applicable)

UNeHealth personnel

Sponsored Programs Accounting personnel


Revision #4
Created 30 September 2019 17:24:19 by James Geiger
Updated 21 November 2019 19:04:52 by James Geiger