Investigator initiated trials - pharma responsibilities
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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?
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
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.