THE CTA is one of the many key documents that govern the conduct of clinical trials. They serve as a legally binding contract between a sponsor, a site and a researcher and describe the responsibilities and obligations of each party for the clinical trial. It is imperative that researchers and sites understand the importance of developing, negotiating and executing CTAs, as effectiveness in these areas increases efficiency, protects researchers/sites and subjects, and helps advance research. If one of the parties to the Contract decides to take legal action, this Agreement will specify the jurisdiction in which the matter will be dealt with. A Data Use Agreement (DUA) is used when data is transferred in the absence of provisions in a sponsored research agreement or CTA. If a third party, e.B. a clinical investigator who negatively affects the CTA between the sponsor and the site, the sponsor will compensate for the loss and assume full responsibility. This section of the agreement is often overlooked by sponsors, CROs, and locations. The purpose of this section is to explicitly state the description of the research project. You would like to document the overall purpose of the agreement in this section. The payment terms and schedule also state what the search site is NOT paid for. For example, in a post-approval clinical trial, the sponsor may not want to make the medical device available for free. A Clinical Trial Agreement (CTA) governs the relationship between the study sponsor providing the device or drug to be studied, as well as the financial support for it, and the research institution providing the study data and results.
A clinical trial is defined as a study of human subjects determined to question the effectiveness of a particular behavior or biomedical intervention, such as. B as a treatment, behavioral strategy, drug, medical device or nutritional strategy. Kunal is the founder of the Clinical Trials Podcast, a podcast and blogging platform for clinical research professionals. Its goal is to interview leading experts in clinical trial management to help you accelerate your career and become a more effective leader. He enjoys connecting like-minded people, introducing new ideas and immersing himself in a continuous learning environment. A Clinical Trial Agreement (CTA) governs the relationship between the study sponsor and the research institution that provides the study data and results.3 min read In this article, I will present nine key elements of a Clinical Trial Agreement (CTA). You will learn the purpose of these components and how they can protect you in case of conflict or disagreement. In general, the purpose of a clinical trial is to collect data on the safety and efficacy of a particular medical device. The investigator and the sponsoring company negotiate a budget and a CTA for each clinical trial. When negotiating this type of contract, it is important to protect your reputation, negotiate strategically and rely on your experience and expertise. Many standard contracts for research institutions assume that the clinical trial is an FDA-regulated drug or medical device study, that the sponsor will provide the study product and protocol, and that the costs will be fully funded by the sponsor. It is not surprising to us that clinical research is a regulated industry.
But what if the clinical location provides incomplete or incorrect data to the sponsor? Or is he reluctant to allow a CRO to monitor data on-site? Whether you`re new to clinical research agreements or a contractual ninja, at some point there`s at least one agreement you can think of that could have been phrased differently. The website may recognize that there is more work involved in a study than expected. Or the proponents decide to revise the protocol, which in turn affects the milestone payment plan in the CTA. Data from a clinical trial are the property of the study sponsor, unless otherwise specified in the agreement. If a signed CTA is agreed, sponsors have the right to collect data prior to contract termination, and sites receive compensation for testing activities performed by research staff. In imaging and molecular diagnostics, a research study is considered a clinical trial if the information obtained from the test in question influences medical decisions and therefore has an influence on the result. Studies that do not use the data in this way, but simply look at a new diagnostic approach, are not considered clinical trials. In the United States, the Sunshine Act provides for increased control over payments to health organizations and health professionals. The project description contains the necessary details of the type of agreement. Sponsors undertake to communicate the results of the study for ethical reasons. Researchers at clinical sites, on the other hand, are enthusiastic about publishing research data. On the other hand, proponents and CROs are required to inform the IRB/EC directly of any non-compliance that could affect the safety and well-being of subjects.
Just like your auto or health insurance, locations, CROs, and sponsors typically have clinical trial insurance to protect themselves or the parties involved in a clinical trial. The purpose of this section is to document the agreement between the site and the sponsor on the retention period of the study data after the end of the study (usually at least two years). .