Trials involving medicinal products licensed in any EU Member State if: they relate to the licensed range of indications, dosage and form; or they involve off-label use (such as in paediatrics and in oncology etc.) if this off-label use is established practice and supported by sufficient published evidence and/or guidelines.
The role of the Trial Steering Committee (TSC) is to provide the overall supervision of the trial. Ideally, the TSC should include members who are independent of the investigators, their employing organisations, funders and sponsors. The TSC should monitor trial progress and conduct and advise on scientific credibility. The TSC will consider and act, as …
The Trial Management Group normally includes those individuals responsible for the day-to-day management of the trial, such as the Chief Investigator, statistician, trial manager, research nurse, data manager. The role of the group is to monitor all aspects of the conduct and progress of the trial, ensure that the protocol is adhered to and take …
The process of intervening with the aim of enhancing health or life expectancy. Sometimes, and particularly in statistical texts, the word is used to cover all comparison groups, including placebo and no treatment arms of a controlled trial and even interventions designed to prevent bad outcomes in healthy people, rather than cure ill people.
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26 July, 2022