Medical Monitor ResponsibilityAny reference to Medical Monitor approval of protocol-specific eligibility criteria is removed from the protocol. The Principal Investigator (PI) may consult with the Medical Monitor/Sponsor for advice or clarification of any eligibility criteria and may share risk factor information pertinent to the patient, but the decision of whether a patient meets the eligibility criteria to enroll to the protocol is the responsibility of the PI.Rationale:This is a clarification of the responsibilities of the Principal Investigator and the role of the Medical Monitor during eligibility to ensure optimal execution of the study; therefore, Genentech does not consider this to represent a substantial change to the protocol as this is a clarification of the responsibilities of the Principal Investigator for determining eligibility and the role of the Medical Monitor to ensure appropriate execution of the study.
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