DMID Clinical Research Agreements

Agreements a​re often negotiated between NIAID, through the Division of Microbiology and Infectious Diseases (DMID), and outside parties, to cooperate in the conduct of a research project. The agreement addresses the responsibilities and obligations of the parties specific to the objectives of the proposed research.

For clinical research agreements, DMID has agreement specialists located in the Office of Regulatory Affairs (ORA) to help guide staff and provide additional information on the appropriate NIAID/DMID template to use, and the negotiation and approval process.

The signature of the Director of DMID or designee must be obtained for any agreement to be effective.

The following are the most common agreements used by DMID for clinical research.

Confidentiality Disclosure Agreement (CDA): A CDA enables and covers the terms for two or more parties to exchange confidential information. Government employee confidentiality is assured by law (Title 18 USC 1905) and therefore a CDA is not required by DMID if DMID is the receiving party. However, the other party may still request a CDA. DMID staff should determine the need for a CDA prior to going on site visits or interacting with non-government parties.

Material Transfer Agreement (MTA): An MTA is a legal document defining the conditions under which materials can be transferred and used among clinical research sites and laboratories, usually for transferring unpatented biological materials to non-profit entities or for-profit entities for research purposes only.

Materials are transferred for non-human use only; however, if the material originated in humans, regulations under 45CFR46 apply and 21 CFR 50. This type of agreement is also used to transfer investigational products from DMID for non-human use.

Clinical Trials Agreement (CTA): A CTA is an agreement negotiated between the Institute (Government) and outside entities (usually manufacturers of an investigational product) who decide it is to their mutual benefit to cooperate in the conduct of a clinical research protocol. The agreement addresses the responsibilities and obligations of the parties in the conduct of the study as well as the handling of intellectual property and proprietary information.

Clinical Materials and Supplies Agreements (CSMA): A CMSA is a type of CTA. A CMSA is used when a company/investigator or DMID is only providing the test article and receiving data (for example, clinical trial reports and/or SAS datasets) and not involved in the clinical trial. DMID Program Officers work with the ORA Agreement Group to ensure the appropriate terms are used in each section sections and appropriate language for the elements and responsibilities associated with the agreement are included.

Letter of Agreement (LoA) or Letter of Transfer (LoT) or Letter of Understanding (LoU).): These letters are used to allow transfer of information or materials to or from a contractor or company when not specified in another agreement or in the contract under which they were produced. The ORA Agreement Group in will work with Program to develop an appropriate LoA.

Clinical Research and Development Agreements (CRADA): A CRADA is used for a partnership in which DMID/NIAID provides personnel, services, facilities, equipment, or other resources with or without reimbursement (but not funds to non-federal parties) and the company provides funds, personnel, services, facilities, equipment, or other resources toward the conduct of specified research or development efforts that are consistent with the mission of DMID/NIAID. CRADA are developed through the DMID Office of the Director.

Inter Agency Agreement (IAA): An IAA is used to define work between NIAID/DMID and another federal agency. The IAA explicitly defines what each party will contribute, including responsibilities of each party, what will be done, timeline of work, and funds transferred related to the collaboration. IAAs must be coordinated through the DMID Office of the Director.

Intra-Departmental Delegation of Authority (IDDA): An IDDA is a delegation of authority to obligate and outlay funds. It is only available for intra-departmental use. IDDAs must be coordinated through the DMID Office of the Director.

Memorandum of Understanding (MOU): An MOU is a non-binding agreement that outlines how NIAID and other government agencies or parties intend to collaborate on a series of related projects. A MOU may be of sufficient magnitude, complexity, or sensitivity that they warrant approval of the NIAID Director or designee. ​​​

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