Contracting

The UF Office of Clinical Research (OCR) Contracting team represents the University of Florida in the preparation, negotiation, and activation of all sponsored agreements under the purview of the OCR (with a specific focus on federal and industry funded clinical research contracts).

The OCR Contracting team is also responsible for the preparation, negotiation and activation of incoming and outgoing Confidentiality Disclosure Agreements (CDAs), Data Transfer & Use Agreements (DTUAs), Subawards, and other complex contractual agreements under the purview of the OCR.

Contracting

Business Associate Agreements

The HIPAA Privacy Rule requires all Covered Entities to have a signed Business Associate Agreement (BAA) with any vendor or contractor they hire that may come in contact with protected heath information (PHI).

Contracting

Clinical Trial Agreements

Clinical trials that are conducted under the U.S. Food and Drug Administration (FDA) regulations require a contract between the site and the study sponsor or clinical research organization (CRO).

ContrActing

Confidentiality Disclosure Agreements

A Confidentiality Disclosure Agreement (CDA) is a legal contract between at least two parties that outlines confidential material, knowledge, or information that the parties wish to share with one another for certain purposes, but wish to restrict access to or by third parties.

Contracting

Data Transfer & Use Agreements

A Data Transfer & Use Agreement (DTUA) is used when transferring protected health information (PHI), including de-identified data, limited data sets (LDS), and fully identifiable data from one party to another. A DTUA defines the rights, responsibilities, and obligations of both the providing and receiving parties.

Contracting

Master Agreements

A Master Agreement is a document agreed between two parties that sets out standard terms that apply to all the transactions entered into between those parties. Each time a transaction is entered into, the terms of the master agreement do not need to be re-negotiated and apply automatically.

Contracting

Material Transfer Agreements

A Material Transfer Agreement (MTA) is a contract that governs the transfer of tangible research materials between two organizations, when the recipient intends to use it for his or her own research purposes. The MTA defines the rights of the provider and the recipient with respect to the materials and any derivatives.

Contracting

Subcontracts

A subcontractor is normally defined as a third party contracted to conduct a significant portion of the scope of work or research plan included in a research proposal. The subcontract will include appropriate flow-down terms and conditions of the prime grant or contract.