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Investigator initiated trials - pharma responsibilities



  • MS
    22/08/2019 11:13
    Legal/regulatory responsibilities sit with researchers in investigator initiated trials. Could anyone provide their view on regulatory responsibilities resting on pharma (MAH) supporting these type of studies?
  • Anon
    22/08/2019 13:28
    I don't understand. Impossible for IIT to have regulatory responsibility resting on MAH. sponsor (in this case investigatir) can only have the responsibility of a sponsor..... there's another question like this on this forum. See answer to that
  • MS
    22/08/2019 14:35
    Pharma supporting and supplying IIS retains responsibility to ensure that their supplies are manufactured to GMP or that they exchange safety information with the investigator, just as an example. Could I just ask those with experience of working at the intersection of pharma and investigator led research to not be discouraged and voice their opinion please. thank you
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