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Accelerated Clinical Trial Agreement

Contract negotiations are a complex process and are often identified as a major obstacle to effective study opening. Data from a 2010 CTSA Contracts Processing study described an average trading time of 103 days, which was reduced to 73 days when a “mastery contract” was used. To overcome this obstacle, the CTSA Master Contracts Working Group, Comprised of legal experts from 25 CTSA institutions, collaborated with industry and the university industry demonstration partnership to develop a standardized clinical trial agreement – a unique agreement that will be used (voluntarily) by each participating institution and each sponsor to reduce contract negotiations for industry-sponsored multi-site trials, particularly for Phase 2b and 3 clinical trials. ACTA is available to all reviewers in an industry-sponsored multi-center study. The Office of Corporate Research Collaborations is ready to facilitate this process. If you are interested in enjoying the benefits of ACTA, you can contact Oshrat Benmoshe-Doriocourt, LL.M. by email to oshrat.benmoshe@duke.edu. “The acceptance of ACTA can significantly reduce the time it takes to meet the process as it no longer conducts contract negotiations,” says Oshrat Benmoshe-Doriocourt, LLM, Senior Corporate Agreement Manager in Duke`s Office of Corporate Research Collaborations. Benmoshe-Doriocourt is a member of the CTSA Master Contracts working group. As a result, a CTSA Master Contracts working group created the Clinical Trials Agreement (ACAC). It is a standardized clinical trial agreement, which clearly defines the contractual obligations of both parties and is a language that, while perhaps not ideal for both parties, is acceptable to both parties. ACTA is now available for use on Duke and other CTSA sites. Data from a 2010 study at 29 clinical-translational Science Award (CTSA) sites showed that the average trading period – from the first contact between researchers and industry to the final completion of a clinical trial agreement – could be reduced from an average of 55 days to 22 days if a master`s contract was used.

Contract negotiations can significantly slow down progress in launching a clinical trial. Clinical trials conducted at the University of Louisville (z.B. Clinical Trials Unit) institutions that do not require the participation of third parties should require only the implementation of ACAC with the ULRF. A sub-price for state-funded clinical trials that denies the need for painstaking negotiations. Approved for use by CTSA, nih and FDP players. The launch of human studies in several institutions is complicated and can sometimes take many months. There are many participants in these delays, but one of the main causes is the process of auditing and negotiating various agreements related to research activities. For each new study proposed by a researcher or sponsor, it may be necessary to review several agreements, such as. B a confidential disclosure agreement, a clinical trial agreement, an agreement on the use of data, an agreement to transfer equipment. The Accelerated Research Agreements Initiative provides for agreements acceptable to participating institutions and organizations; if they are used, the initiation of the study is accelerated.

Institutions and industries can use the Accelerated Clinical Trial Agreement for multi-site studies initiated by sponsors. This streamlined process will allow sites to participate earlier in clinical trials without undue delay in contract negotiations. In order to streamline the negotiation of confidentiality agreements and clinical study contracts and reduce the time it takes to launch clinical studies at the University of Louisville (UofL), the University of Louisville Research Foundation, Inc.