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Clinical investigator information


A clinical investigator involved in a clinical trial is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. The Clinical Investigator must also meet requirements set forth by the FDA, EMA or other regulatory body. The qualifications must be outlined in a current resume and readily available for auditors.

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Clinical investigator

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A clinical investigator involved in a clinical trial is responsible for ensuring that an investigation is conducted according to the signed investigator...

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Investigator

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a police rank in many countries Clinical investigator, an investigator involved in a clinical trial New investigator, a designation for less experienced...

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Clinical trial

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interest of the clinical investigator in the outcome of the study. For example, the applicant must disclose whether an investigator owns equity in the...

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Preclinical development

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studies or nonclinical studies) is a stage of research that begins before clinical trials (testing in humans) and during which important feasibility, iterative...

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Journal of Clinical Investigation

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The Journal of Clinical Investigation (JCI) is a twice-monthly peer-reviewed medical journal covering biomedical research. It was established in 1924 and...

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Principal investigator

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expenditures on a given research project. A co-investigator (Co-I) assists the principal investigator in the management and leadership of the research...

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MEK inhibitor

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pathway which is often overactive in some cancers. (See MAPK/ERK pathway#Clinical significance.) Hence MEK inhibitors have potential for treatment of some...

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American Society for Clinical Investigation

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The American Society for Clinical Investigation (ASCI), established in 1908, is one of the oldest and most respected medical honor societies in the United...

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European Journal of Clinical Investigation

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The European Journal of Clinical Investigation is a monthly peer-reviewed medical journal covering all aspects of biomedical research. It was established...

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Good clinical practice

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Clinical Practice. Glossary Principles of ICH GCP Guidelines for: institutional review board (IRB) / independent ethics committee (IEC) investigator trial...

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Journal of Molecular Medicine

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and Physicians. From 1992 to 1994, the journal's title was The Clinical Investigator. It covers research in the areas of molecular and translational...

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ISO 14155

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principal investigator The standard ISO 14155:2011 is an assessable standard and hence is certifiable. The standard regards good clinical practices and...

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Phases of clinical research

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The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process...

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Clinical research coordinator

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clinical practice (GCP) under the auspices of a Principal Investigator (PI). Good clinical practices principles have been defined by Madelene Ottosen...

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Clinical trial portal

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conduct, manage and review the trial. A clinical trial investigator portal (also known as clinical investigator portal) focuses on facilitating sponsors'...

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Clinical epidemiology

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Society for Clinical Investigation in 1938. It is sometimes referred to as "the basic science of clinical medicine". When he coined the term "clinical epidemiology"...

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Investigational New Drug

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supply consistent batches of the drug. Investigator information on the qualifications of clinical investigators, that is, the professionals (generally...

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Albert Einstein College of Medicine

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a M.D. program, a Ph.D. program in the biomedical sciences and clinical investigation, and two Master of Science (M.S.) degrees. Admission to Einstein’s...

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Clinical equipoise

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or during their required clinical trials.[citation needed] An ethical dilemma arises in a clinical trial when the investigator(s) begin to believe that...

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Clinical Biochemistry

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Clinical Biochemistry is a peer-reviewed scientific journal covering the analytical and clinical investigation of laboratory tests in humans used for diagnosis...

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Glossary of clinical research

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trial. (ICH E6) Coordinating Investigator An investigator assigned the responsibility for the coordination of investigators at different centers participating...

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Clinical neuroscience

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Clinical neuroscience is a branch of neuroscience that focuses on the scientific study of fundamental mechanisms that underlie diseases and disorders of...

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Investigation

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Investigation, the work of a detective Investigation, the work of a private investigator Criminal investigation, the study of facts, used to identify,...

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Clinical Infectious Diseases

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Clinical Infectious Diseases is a peer-reviewed medical journal published by Oxford University Press covering research on the pathogenesis, clinical investigation...

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