ICH E6(R2) 4.5.1:Investigators must follow the protocol approved by the IRB/IEC.
Any modification that is not pre-specified must be approved by sponsor and IRB before continuing.
Only deviations eliminating immediate hazard can be done without prior approval; in this case, continuation requires sponsor + IRB agreement.
[References:ICH E6(R2) §4.5.1., ]
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