Glossary

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  • Data and Safety Monitoring BoardA Data and Safety Monitoring Board (DSMB) is an independent group of experts set up to protect patient safety during a clinical trial. This board periodically reviews clinical study data (and they have access to unblinded data in case of blinded studies), incidental event reporting, and(...)
  • DSMBA Data and Safety Monitoring Board (DSMB) is an independent group of experts set up to protect patient safety during a clinical trial. This board periodically reviews clinical study data (and they have access to unblinded data in case of blinded studies), incidental event reporting, and(...)
  • Data exclusivityData exclusivity refers to the period during which the data of the original marketing authorisation holder is protected. It is the time during which another company cannot use the originator’s data in support of another marketing authorisation application, i.e.: generics, hybrids, biosimilars.(...)
  • Data ManipulationData manipulation is the process of taking data and manipulating (reformatting) it to be easier to read or better organised. For example, a list of data entries could be organised in alphabetical order, making it easier to view and find information.However, these practices should be used(...)
  • Data MergingData merging is a process that involves combining data from different sources, and providing users with a single view of these data.For example: data from different hospital sites within a clinical trial will be combined for analysis data generated from entirely separate scientific studies(...)
  • Data MiningData mining is the practice of searching through existing large sets of data to find useful patterns or trends. Data mining can generate new hypotheses or new ideas for diagnosing, preventing, or treating diseases. It can, for example, lead to predictions for individual responses to medicines,(...)
  • Data Monitoring CommitteeData Monitoring Committee
  • DMCData Monitoring Committee
  • Dear Doctor letterDear Doctor letters are correspondence ― often in the form of a mass mailing from the marketing authorisation holder of a human medicine or biologic ― intended to alert doctors and other healthcare providers about important new or updated information regarding a marketed medicine or(...)
  • Decentralised procedureThe decentralised procedure is a process for authorising medicines in more than one European Union member state at the same time.

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