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In drug development, serious adverse event (SAE) is defined as any untoward medical occurrence during a human drug trial that at any dose Results in death; Is life-threatening; Requires inpatient hospitalization or causes prolongation of existing hospitalization; Results in persistent or significant disability/incapacity
The Office for Human Research Protections (OHRP) is a small office within the United States Department of Health and Human Services (DHHS), specifically the Office of the Assistant Secretary for Health in the Office of the Secretary of DHHS, that deals with ethical oversights in clinical research conducted by the department, mostly through the National Institutes of Health (NIH).
The activity that is most commonly associated with pharmacovigilance (PV), and which consumes a significant number of resources for drug regulatory authorities (or similar government agencies) and drug safety departments in pharmaceutical companies, is that of adverse event reporting. Adverse event (AE) reporting involves the receipt, triage ...
Local investigators also are responsible for making an independent judgment of these reports, and promptly informing the local IRB of all serious and study treatment-related adverse events. When a local investigator is the sponsor, there may not be formal adverse event reports, but study staff at all locations are responsible for informing the ...
In 1967, the Florida Legislature merged the duties and responsibilities of several state criminal justice organizations to create the Bureau of Law Enforcement. Bringing together the resources of the Florida Sheriffs Bureau, the State Narcotics Bureau, and the law enforcement activities of the Anti-Bookie Squad of the Florida Attorney General's Office, the original Bureau of Law Enforcement ...
As of 2025, it may become harder to take videos of law enforcement in Florida, even if they're breaking the law themselves. A new law going into effect on Jan. 1 requires people to move back 25 ...
A new state law set the stage for ending the state’s 21 panels. In essence, civilians in Florida will no longer be able to complain about alleged police brutality outside of the department’s ...
Over the years, the uniform crime report developed into a broad utility for summary-based reporting of crimes. By the late 1970s, the law enforcement community saw the need for a more detailed crime reporting program that would meet the needs of law enforcement agencies in the 21st century. Testing for the new NIBRS system began in South Carolina.