ICH E6(R3) – Contains a cumulative list of ADRs that are expected for the investigational product being administered to participants in a clinical trial. The RSI is included in the Investigator’s Brochure.
ICH E6(R3) – Contains a cumulative list of ADRs that are expected for the investigational product being administered to participants in a clinical trial. The RSI is included in the Investigator’s Brochure.