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The program is an outgrowth of the 1986 National Childhood Vaccine Injury Act (NCVIA), which requires health care providers to report: Any event listed by the vaccine manufacturer as a contraindication to subsequent doses of the vaccine. Any event listed in the Reportable Events Table that occurs within the specified time period after vaccination.
Health professionals and consumers may also report these events to the products’ manufacturers. If a manufacturer receives an adverse event report, it is required to send the report to the FDA as specified by regulations. The MedWatch site provides information about mandatory reporting.
An after action report (or AAR) is any form of retrospective analysis on a given sequence of goal-oriented actions previously undertaken, generally by the author themselves. The two principal forms of AARs are the literary AAR, intended for recreational use, and the analytical AAR, exercised as part of a process of performance evaluation and ...
Security incident report, a report used to keep track of thefts, losses and other types of security events Vehicle accident report or accident report form , a report about a traffic collision . Some jurisdictions mandate each of the involved parties to file a report of the event, either separately or together.
Adverse events categorized as "serious" (results in death, illness requiring hospitalization, events deemed life-threatening, results in persistent or significant incapacity, a congenital anomaly or medically important condition) must be reported to the regulatory authorities immediately, whereas non-serious adverse events are merely documented ...
An executive summary (or management summary, sometimes also called speed read) is a short document or section of a document produced for business purposes. It summarizes a longer report or proposal or a group of related reports in such a way that readers can rapidly become acquainted with a large body of material without having to read it all.
International Accounting Standard 10 Events after the Reporting Period or IAS 10 is an international financial reporting standard adopted by the International Accounting Standards Board (IASB). It contains requirements for when events between the end of the reporting period and the date on which the financial statements are authorised for issue ...
A significant event audit (SEA), also known as significant event analysis, is a method of formally assessing significant events, particularly in primary care in the UK, with a view to improving patient care and services. To be effective, the SEA frequently seeks contributions from all members of the healthcare team and involves a subsequent ...