What is an Investigational Medicinal Product?

A pharmaceutical form of an active substance or placebo being tested, or used, as a reference in a clinical trial, including products already with a marketing authorisation but, for the purposes of the trial, used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form (SI 2004/1031).

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What is a Medical Device?

According to the Medical Devices Directive (MDD), a ‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

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Which Sponsor team do I contact for NuTH sponsored high risk studies?

  • Please direct all urgent sponsor management queries to: Tnu-tr.sponsormanagement@nhs.net (e.g. this includes queries relating to Annual Progress Reports, End of Study Reports, Trial Management Group meetings, Risk Assessments, amendments, sponsorship requests etc.)
  • Please direct all urgent monitoring queries to: Tnu-tr.trialmonitoring@nhs.net (e.g. this includes queries relating to Monitoring Plans, Monitoring Reports, confirmation of site actions completed etc.)
  • Please direct all urgent safety queries to: Tnu-tr.safetyreporting@nhs.net (e.g. this includes SAEs, SUSARs, Deviations, Development Safety Update Reports, Reference Safety Information updates/reviews)
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