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Who would be responsible in case of SAE happened purely due to non-adherence to protocol by PI provide by sponsor ?

April 26, 2017Case happened non-adherence Pi Protocol purely responsible SAE sponsor

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Who would be responsible in case of SAE happened purely due to non-adherence to protocol by PI provide by sponsor ?

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CHP: Repeat after me: “The PI is responsible for the protocol and following it to the letter”. That particular PI would or should be history and certainly would not be the PI on any study I was involved in. The PI MUST follow the protocol as written and signed by her/him. If they do not, the buck stops with themselves.