Contracts

Before a study can be sent to any committee for review, it is first sent to the Contracts and Budgets teams. The Contracts department reviews each study to determine whether the research study requires any contracts with external agencies. They ensure contract terms are fair and protect the investigators, the participants, and the institution. The Research Contracts Office is responsible for the review and negotiation of all research related agreements in accordance with Hackensack Meridian Health network policies. Our team of Contract Specialists ensures that the terms of an individual contract are negotiated to the satisfaction of all parties, while protecting the rights of the Institution, the Investigator, and study participants. More information about the contracts process and workflow, can be found here. All research agreements must be reviewed by the Research Contracts Office prior to study start-up/initiation. The Research Contracts Office must also be notified of study amendments and closure. Investigators are asked to provide the following documents for review:

• Protocol
• Informed Consent Form
• Budget
• Contracts, such as the Clinical Trial Agreement, Material Transfer Agreement, Data Transfer Agreement, or Statement of Work
• HMH-DUA-Guidance-Memo (if applicable)
• HMH Data Use Agreement Intake Form (if applicable)
• HMH Contract Intake Form (if applicable)
• Contact details of other parties

Please note: Before submitting documents to the Contracts/Budgets teams, please be sure that your eResearch application is complete and has been submitted by the study team. Please do not submit documents to individual teams separately without a corresponding eResearch submission. This impedes the team’s ability to conduct a comprehensive review of your application and may cause delays.

Budgets

The Budget team develops and negotiates budgets for industry-sponsored and investigator-initiated studies. The Budgets Office serves to guide investigators through the processes by:

• Collaborating with all relevant parties to review and implement a feasible budget.
• Performing a thorough Medicare Coverage Analysis (MCA) to ensure compliance with Hackensack Meridian Health’s billing policies and -Medicare rules as pertaining to private insurance provider agreements. More information about Medicare coverage of clinical trials is available here.
• Monitoring the receipt of clinical trial payments from sponsors and assisting with post-award management by distributing payments to the appropriate departments/accounts based on the internal budget.
• Performing budget management and reporting.

Investigators are asked to provide the following information for review:

• Protocol
• Informed Consent
• Budget
• Contract

The Budget Office must be notified of study closures and amendments, when applicable.

For more information, please contact Sergio Garcia, MBA, MHA.