Introduction

GettingUnderstanding Started

Industry

Who can help me navigate UNMC’s infrastructure for industry-sponsored research?

Notify your department administrator and the UNeHealth contracts office when 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

Defining Roles and Responsibilities for Initiation ofSponsored Research

Effective management of industry-Industry-sponsored projectscontracts ismust abe collaborativereviewed effortand amongnegotiated principalbefore investigators,being departmentsigned. administrators,SPA negotiates non-clinical and clinical research coordinators,agreements Sponsoredwith Programsthe Administrationexception (SPAdmin),of Phase I-IV Clinical Trial Agreements negotiated by UNeHealth.

Non-clinical Research

Non-clinical research is wide ranging and Sponsoredmay Programsbe Accountingmost (SPAccting)

easily

Principal investigators

Lead and direct all aspects of the study, including budget negotiations, regulatory submissions, and study activities Identify project personnel and collaborators Ensure the integrity and timeliness of information provided to SPAdmin Sign internal forms and verify that Conflict of Interest disclosures are current Obtain regulatory approvals of research prior to initiating the project

Departmental personnel (administrators and clinical coordinators if applicable)

Assist PIs with study start-up activities, which include negotiating budgets and submitting IRB applications, and submitting and updating clinical trial matrices and coordinating consent form approvals.Manage UNMC’s financial systems, maintaining the integrity of the financial transactions in those systems in keeping with UNMC Policy #8012. Generate internal forms for PI signature and sign-off; internal forms translate the study budget attached to the contract to salary effort Interface with SPAdmin, sponsors, and regulatory bodies

UNeHealth personnel

Negotiate agreements and amendments to protect institutional and investigator interests and ensure compliance with sponsor and institutional requirements Review Conflict of Interest disclosures for project personnel Review and approve internal forms prior to institutional signature Coordinate with industry sponsors Prepare and finalize awards for set-updefined by SPAcctingwhat Doesit notis negotiate the budget. The investigator must submit the negotiated budget to SPAdmin to be attached to the final contract

Sponsored Programs Accounting personnel

Set up awards Manage effort reporting certifications Monitor program revenue, cost share, and cost allowability Invoice sponsors Prepare and submit financial reports to sponsors

Starting up anot. Non-clinical Studyresearch Funded by Industry

Nonclinical studies dodoes not involverequire informed consent by human subjects or involve data or specimens with personalProtected healthHealth identifiers.Information (PHI). The scope of work couldmay includeor may not involve animals and may be described as laboratory investigations, otherresearch, testing, or provision of services. Non-clinical industry-funded projects typically have a defined period, scope of work, and deliverables such as research data or reports.

SPAdmin negotiates non-clinical agreements.

Clinical Research

Clinical research is defined as research that involves human subjects as participants and/or requires the informed consent of a human subject. In addition to clinical trials (can we insert link to UNeHealth page), clinical research encompasses physiologic studies as well as any projects involving human subject data or specimens.

With the exception of Phase I-V Clinical Trials, SPAdmin negotiates these agreements.

Who should review the contract?

If the work involves development of or potential for intellectual property, UNeMed, UNMC’s technology transfer organization, should review the contract.

If the work involves transfer of human samples, a therapeutic product, or other biologic material, it requires a Material Transfer Agreement that should be completed by UNeMed.

UNeMed Web: unemed.com/services/material-transfer

UNeMed Phone: 402-559-2468

All other contracts or contracts linked to other federal or other grants should be submitted to SPAdmin.

What does UNeHealth require prior to reviewing a contract?

Prior to contract review, UNeHealth requires three items:

Editable contract template from the sponsor (Word document) Scope of work Contact information for the sponsor’s negotiator

All three items should be attached to a single email and sent to the SPAdmin Coordinator for Industry OR submitted through the ADIS Contract Intake.

Who negotiates the contract?

As noted above, depending on the focus of the research, UNeMed or SPAdmin will negotiate the agreement.

Who signs the contract?

The Director of SPAdmin or their designee signs nonclinical agreements as the official signature authority for sponsored projects at UNMC.

Finalizing Awards

Nonclinical awards may be set up as soon as the contract is fully executed and the internal forms are approved.

Starting up a Clinical Study Funded by Industry

Studies that involve the participation of or require informed consent by human subjects are considered clinical studies, whether trials are of new therapeutics or devices, observational studies, registries involving identified data or specimens, or physiologic studies.

What does UNeHealth require prior to reviewing the contract for a clinical trial or device study?

Prior to contract review, SPAdmin requires:

Editable contract template from the sponsor (Word document) Protocol Contract Questionnaire signed by the PI Contact information for the sponsor’s negotiator All four items should be attached to a single email and sent to the UNeHealth Coordinator.

UNeHealth Coordinator contact information is available on their website. The SPADMIN Coordinator can also give access rights to and train users on the ADIS Contract Intake.

Who negotiates the contract?

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

UNeHealth negotiates the contract Departmental staff negotiate the budget IRB reviews the IRB application and consent form

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?

Signatory to any contract will be the parties to the agreement. UNeHealth coordinates the signature process. Signatures always include a UNMC institutional official and will include a UNeHealth signatory if UNeHealth is a party to the agreement. The PI will read and sign acknowledgement of the terms but is NOT a part to the contract. NOTE: PI’s do not have signature authority to mind UNMC to contracts.

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/SPAdmin should be contacted and should review a CDA prior to signing, which is typically done by an institutional official. Forward the CDA request and template to the SPAdmin Coordinator for Industry for negotiation. 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.

Upon IRB release, SPAdmin prepares the award, SPAccting 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:

Checklist, which lists the account number (known as the WBS), personnel, effort, budget, regulatory requirements, and budget and award periods Internal budget Award document Routing form signed by the PI