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

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. More.

I cant really gove you an answer,but what I can give you is a way to a solution, that is you have to find the anglde that you relate to or peaks your interest. A good paper is one that people get drawn into because it reaches them ln some way.As for me WW11 to me, I think of the holocaust and the effect it had on the survivors, their families and those who stood by and did nothing until it was too late.