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Acta Agreement Clinical Trial

ACTA is available to each reviewer of an industry-sponsored multi-centre study. The Office of Corporate Research Collaborations is ready to facilitate this process. If you are interested in the benefits of ACTA, you can contact Oshrat Benmoshe-Doriocourt, LL.M. by e-mail at oshrat.benmoshe@duke.edu. Institutions and industries can use the Accelerated Clinical Trial Agreement for multi-site studies initiated by sponsors. This optimized process will allow sites to participate earlier in the clinical trial process, without unnecessary delays in contract negotiations. As a result, a CTSA Master Contracts Working Group launched the Accelerated Clinical Trial Agreement (ACTA). It is a standardized agreement on clinical trials, which clearly defines the contractual obligations of both parties and presents a language that, while it may not be ideal for both parties, is acceptable to both parties. ACTA is now available for use on Duke and other CTSA sites.

Contract negotiations are a complex process and are often identified as a major obstacle to the effective implementation of studies. Data from a 2010 CTSA Contracts Processing study described an average trading time of 103 days, which was reduced to 73 days when using a “framework contract”. To overcome this hurdle, the CTSA Master Contracts Working Group, made up of legal experts from ~25 CTSA institutions, collaborated with industry and the industry`s industry demonstration partnership to develop a standardized agreement for clinical trials – a unique agreement that can be used (voluntarily) by any participating institution and sponsor to negotiate contracts for industry-sponsored multi-site projects. Reduce studies. especially for Phase 2b and Phase 3 clinical trials. “Acac acceptance can significantly reduce the time it takes to commission a test because it makes the need to negotiate contracts unnecessary,” says Oshrat Benmoshe-Doriocourt, LLM, senior Corporate Agreement Manager at Duke`s Office of Corporate Research Collaborations. Benmoshe-Doriocourt is a member of the CTSA Master Contracts Working Group. Contract negotiations can significantly slow progress in launching a clinical trial. A outsourcing model for publicly funded clinical trials, which cancels lengthy negotiations.

Authorized for use by CTSA stakeholders, NIH and FDP. UofL researchers often conduct clinical trials in one or more hospitals or third-party institutions. Each of these institutions is linked to the university and allows for field research by UofL researchers, but each is a separate legal entity. Therefore, these establishments typically require separate and direct agreements with the sponsor of the clinical trial (for example, an exemption letter (LOI) or an establishment use agreement (FUA)). Therefore, the sponsor of clinical trials using third-party facilities/services may be asked to enter into a separate agreement with the relevant body, in addition to the CTA with the ULRF. ACTA is now ready for widespread public and adoption. More than 61 institutions have agreed that the conditions are acceptable. Outreach has started reaching out to industry sponsors to find the right opportunity to test the use of the agreement for a clinical trial in the coming months. Launching human studies in several institutions is complicated and can sometimes take many months. There are many contributions to these delays, but one of the main causes is the process of reviewing 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, for example.

B a confidential disclosure agreement, a clinical trials agreement, a data use agreement and a material transfer agreement. . . .

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