Clinical Research Organizations (CROs) provide a variety of services to sponsors and investigators before the start of a clinical trial. These services typically include regulatory matters, clinical trial planning, site selection and initiation, hiring support, clinical monitoring, data management, trial logistics, biostatistics, medical writing, and project management. Sponsors of clinical trials are usually pharmaceutical companies that work with CROs to act as representatives of the company. The University of Washington has framework agreements with many pharmaceutical and medical device companies that carry out clinical trial research. When the parties agree that the UAB will be a center, the sponsor will provide a clinical trial agreement (CTA).
At that time, the process of internal review of the project and the agreement can begin. Some clinical trials initiated by the sponsor will be conducted under a project master agreement (PMA) with the sponsor. In this case, the agreement provided by the sponsor will be a simple work order since the main terms of the agreement have already been negotiated between the parties. The use of Good Clinical Practice (GCP) standards for clinical research is essential for collecting quality data and facilitating the analysis and publication process. Private investigators can outsource research tasks to outsourced research organizations (companies with specialized experience in services that are too expensive or time consuming to be carried out internally).The budget for a clinical trial will be per patient or per visit, with additional items such as start-up costs and fees for clinical trials funded by the UAB industry billed separately.
A sponsoring investigator assumes responsibility as a sponsor of the clinical study and also carries out or oversees the clinical trial. The Office of Sponsored Programs has framework agreements on clinical trials with many pharmaceutical and medical device companies that conduct clinical trial research. Sponsors who design and fund clinical trials (for example, pharmaceutical companies) are required by law to select people who are qualified due to their training and experience to carry out a clinical trial. To determine whether the oversight of private investigators is adequate, the FDA evaluates whether study staff have received adequate training and explanations about the protocol, whether participation of the principal investigator is adequate and ongoing, and whether third parties and contracted research organizations are adequately supervised.
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