21 CFR 56.109(a):IRB must review and approve any protocol amendments before implementation.
ICH E6(R2) 4.5.2:Changes affecting subjects (e.g., genomic testing) require IRB/IEC approval and updated consent.
Thus, site must first obtainIRB approval for revised protocol and ICF.
[References:21 CFR 56.109(a); ICH E6(R2) §4.5.2., ]
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