Glossary

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  • Trial armA trial arm is a group of participants that receives the same interventions, or no intervention, according to the study protocol. Many randomised trials have two arms, but some may have three or even more. This is decided before the trial begins.Trials with several arms (multi-arm) allow more(...)
  • Type I ErrorType I Error occurs in statistical hypothesis testing when a null hypothesis, which is actually true, is incorrectly rejected. Type I errors are also known as 'false positives'; they are the detection of a positive effect where no effect actually exists.As a stark example, Type I errors could(...)
  • Type II ErrorType II Error occurs in statistical hypothesis testing when the null hypothesis is incorrectly accepted. Type II errors are also known as 'false negatives'; they are the failure to detect a positive effect where the effect does exist.Type II errors mean that potentially valuable research goes(...)
  • Unexpected Adverse ReactionAn unexpected adverse reaction is a harmful and unintended response to a medication which is not consistent with the summary of product characteristics (SmPC) or, for investigational medicinal products, the applicable product information or characteristics of the medicinal product.
  • UAEAn unexpected adverse reaction is a harmful and unintended response to a medication which is not consistent with the summary of product characteristics (SmPC) or, for investigational medicinal products, the applicable product information or characteristics of the medicinal product.
  • Unique Device IdentificationThe Unique Device Identification (UDI) is a unique number, or combination of numbers and letters, given to a medical device. It is in two parts: one part identifies the device; the other part identifies the producer. The aim of the UDI system is to improve patient safety: it means devices can(...)
  • UDIThe Unique Device Identification (UDI) is a unique number, or combination of numbers and letters, given to a medical device. It is in two parts: one part identifies the device; the other part identifies the producer. The aim of the UDI system is to improve patient safety: it means devices can(...)
  • United Kingdom Ethics Committee AuthorityUnited Kingdom Ethics Committee Authority (UKECA) http://www.hra.nhs.uk/resources/research-legislation-and-governance/four-nations/"
  • UKECAUnited Kingdom Ethics Committee Authority (UKECA) http://www.hra.nhs.uk/resources/research-legislation-and-governance/four-nations/"
  • Universal Declaration of Human RightsThe Universal Declaration of Human Rights is an international document that states the basic rights and fundamental freedoms to which all human beings are entitled. It was adopted by the General Assembly of the United Nations in 1948, as a result of the experience and atrocities of the Second(...)

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