Clinical Research
CurrentICH GCP E6 R2Informed Consent ProcessComprehension and Execution of Clinical Trial ProtocolsFDA Regulations 21 CRF Parts 11, 50, 54, 56Monitoring, Quality Assurance, and InspectionsIdentification and reporting of AEs and SAEsProtecting Patients Rights and SafetyMaintaining a regulatory binder, housing essential documents including but not limited to 1572.