Roles and Responsibilities of the Clinical Research Team
Responsibilities of investigators can be found in the following sections of the regulations: -IND trials: 21 CFR 312 subpart D -IDE trials: 21 CFR 812 subpart E and subpart G -21 CFR 50 (informed consent requirements) -21 CFR 56 (IRB requirements) -ICH E6 Guidelines 4.1- 4.13 . The investigator must also be aware of any local rules or ................
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