institutional review board approval
- Guideline or reference source
- CDISC Glossary of terms
- ICHE6(r1) Guideline for good clinical practice
- Definition
- 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 IRB, the institution, good clinical practice (GCP), and the applicable regulatory requirements. [ICH E6]
- Related Term
- institutional review board
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