IRB가 GCP 및 관련 규정을 요구사항에 따라 임상시험계획서 및 관련 문서를 검토한 후에 임상시험을 실시해도 된다고 긍정적 결론을 내리는 것

The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRBs, the institution, good clinical practice(GCP), and the applicable regulatory requirements.