Master Study Agreement

Master`s agreements are agreements that embody the agreed terms of a basic relationship between the university and a sponsor. A Master Research Agreement (MRA) may be appropriate when an individual sponsor intends to fund several research projects at the university over a long period of time for specific purposes, but wants an indeterminate duration or scope of work for individual projects. In these cases, the sponsor agrees to finance defined benefit periods for a project according to a detailed purchasing position (SOW). However, the terms and conditions are defined by the MRA and are generally not subject to renegotiation, except in special circumstances; SOW and all project-specific information is added to the MRA in the form of a pre-approved addendum. The MRA must regulate the activities of all projects funded under the agreement and will determine the obligations of the parties in terms of financing, payment, disclosure of intellectual property and the performance of the proposed volume of work for such a project. Master Clinical Trial Agreements (MCTAs) contains agreed terms that define the basic relationship between the university and a sponsor. Once an MCTA is in place, a supplement or study letter is usually generated for each new study to be conducted under the MCTA. The addendum lists the points that are, in particular, for a specific study, such as. B budget and payment conditions, calendar details, protocol name and senior controller. These Addenda are attached to the MCTA. This reduces the need to negotiate the main terms of the agreement, since most of the terms have been agreed and only details need to be negotiated. The use of Master Clinical Trial Agreements is an important tool to start studies as quickly and easily as possible. We now have MCTAs with more than 40 commercial sponsors, and the ARU is constantly working on revisions, renewals and/or new agreements.

As an alternative to an MRA, the sponsor and the university can develop a sponsored research contract (SRA) model with a negotiated set of conditions. This SRA model can then be modified for the various funded research projects, which speeds up the approval process for new research awards. Below is a list of all the companies with which we have ongoing trial agreements. If you are dealing with the following sponsors, please inform them of the use of our MCTA. A for-profit sponsor wishing to develop an MRA with the university should contact the Office of Industry Engagement (OIE) for information: The University of California has also adopted the Clinical Trials Agreement (ACAC). ACTA offers a standardized model for industry-sponsored multi-center studies, thus optimizing the contracting process. NOTE: A federal, regional or foundation sponsor should contact the Office of Sponsored Projects to discuss MR. Negotiating an MRA is a thorough and conscious process. The MRA must take into account contractual conditions that apply over long periods of time and in different circumstances. This is particularly difficult when the sponsor`s future research activities at the university are still under development and specific research themes and projects are still unknown.

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