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Who is responsible for reporting & documenting the adverse events. (PI or CRA or someone else)?

April 26, 2017adverse CRA documenting events Pi responsible

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Who is responsible for reporting & documenting the adverse events. (PI or CRA or someone else)?

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LW: The PI is ultimately responsible for AE reporting and documentation, with causality assessment. CHP: The PI is ultimately responsible for this activity. The act can be delegated but the PI remains responsible. In fact, this is her/his most important responsibility in my view.