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. For industry-sponsored clinical trials, the Clinical Contract Administrator reviews a CTA within two weeks and returns the revised draft to the sponsor upon receipt of responses to requests from investigators and staff. In this article, I will present nine key elements of a Clinical Trials Agreement (CTA). You will learn the purpose of these components and how they can protect you in case of conflict or disagreement. In the United States, the Sunshine Act provides for increased oversight of payments to health organizations and health professionals. The project description contains the necessary details on the type of agreement. Data Use Agreement (DUA): An agreement between the university and another party (academic institution, government agency, or corporation) to exchange a limited data set as defined by HIPAA for research funding purposes. The agreement ensures proper processing of the data exchanged in accordance with data protection laws. Intra-government assignments under the Personnel Act (API): An agreement that sets out the obligations and responsibilities of the parties when a faculty member is temporarily assigned to a federal agency.
The clinical contract administrator sends the final document to the investigator for review and, if approved, for signature. The administrator then receives the appropriate institutional signature(s) and, once fully executed, returns a copy of his or her records to the investigator. Websites want to get paid for their search services. In the case of a multi-year clinical trial, sponsors and CROs want to manage their budget and spending forecasts for current and future years. A Clinical Trial Agreement (CTA) is an agreement between UTHealth and an industry sponsor (typically a pharmaceutical or device company) to conduct a clinical trial in which the protocol is written and provided by the industry sponsor. The agreement (OTC) is also known as a clinical trial or clinical research agreement. It is a contract between an academic institution and another party in relation to a clinical trial or study. Finally, this section of the agreement must clearly indicate where the website must send invoices (name and contact details of the person) as well as the terms of payment (example: payment is made within 45 days). 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. Confidentiality Agreement (CDA or NDA): An agreement that allows University of Washington faculty and staff to share confidential information with external third parties in order to protect and maintain the confidentiality of the information. In general, CDAs are entered into for the purpose of examining a possible research cooperation or licensing agreement. Consortium Agreement: An agreement that governs the conditions for joining a consortium. Principal investigators, research staff and administrators, and others involved in the development, negotiation and execution of the CTA. 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 in human subjects that questions the effectiveness of a particular behavior or biomedical intervention. B such as a treatment, behavioural strategy, drug, medical device or nutritional strategy. Subcontracting: An agreement awarded to the University under a master contract, agreement or grant. .