It is available for others to enhance their knowledge of clinical research.įDA regularly presents at meetings of various professional organizations including the Drug Information Association (DIA), Public Responsibility in Medicine and Research (PRIM&R), the Association of Clinical Research Professionals (ACRP) and the Regulatory Affairs Professionals Society (RAPS). Clinical research training is a course developed by the National Institutes of Health to train its investigators.Online training on human subject protection provided by HHS’ Office for Human Research Protections.Other federal agencies also provide training: See FDA’s workshops and meetings, CDERLearn, CDRH Learn and HHS’ upcoming educational events for more information. Additional training opportunitiesįDA routinely collaborates with HHS’ Office for Human Research Protections and the Department of Veterans Affairs on regional programs focused on protecting people participating in clinical trials. IMPORTANT: Listing a study does not mean it has been evaluated by the U.S. See listed clinical studies related to the coronavirus disease (COVID-19) is a resource provided by the U.S. See SOCRA’s upcoming conferences and courses for more information. Explore 406,391 research studies in all 50 states and in 220 countries.
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FDA clinical trial requirements, regulations, compliance and GCP conferenceįDA co-sponsors two-day workshops with the Society of Clinical Research Associates (SOCRA). The National Heart, Lung, and Blood Institute (NHLBI) leads and supports many studies aimed at preventing, diagnosing, and treating heart, lung, blood, and sleep disorders. They help find new ways to prevent, detect, or treat diseases that are safe and effective. Register for the upcoming course or see the materials from recent courses for more information. Clinical trials are medical studies that involve people like you. It provides FDA's perspectives on new safety concerns, adverse event monitoring, compliance with legal and ethical obligations of clinical research and acceptable scientific and analytic standards in clinical study design and conduct. This three-day course includes lectures given by senior FDA experts and guest lecturers from industry and academia. Clinical Investigator Training CourseįDA's Critical Path Initiative launched a clinical investigator training course for medical professionals who participate in FDA-regulated clinical trials. Finally, we will review the essential ethical consideration involved in conducting experiments on people.The FDA offers training related to our good clinical practice (GCP) regulations and partners with other federal agencies and organizations across the United States to conduct additional training. In the second half of the course, we will explain how clinical trials are analyzed and interpreted. We will also explain some of the mechanics of clinical trials, like randomization and blinding of treatment. In the first part of the course, students will be introduced to terminology used in clinical trials and the several common designs used for clinical trials, such as parallel and cross-over designs. The course will explain the basic principles for design of randomized clinical trials and how they should be reported. The FDA requires that drugs or biologics (e.g., vaccines) are shown to be effective in clinical trials before they can be sold in the US. Results from randomized clinical trials are usually considered the highest level of evidence for determining whether a treatment is effective because trials incorporates features to ensure that evaluation of the benefits and risks of treatments are objective and unbiased. We consider clinical trials experiments because the investigators rather than the patients or their doctors select the treatment the patients receive. cancer screening programs) or health delivery systems (e.g., special care units for hospital admissions). Continuous monitoring in an inpatient medical-surgical unit: a controlled clinical trial. The interventions evaluated can be drugs, devices (e.g., hearing aid), surgeries, behavioral interventions (e.g., smoking cessation program), community health programs (e.g. 3 Brown H, Terrence J, Vasquez P, Bates DW, Zimlichman E. Clinical trials are experiments designed to evaluate new interventions to prevent or treat disease in humans.