Institutional Review Board (IRB) Approval

An Institutional Review Board (IRB) Approval is an affirmative decision or favorable opinion that states that the institutional review broad has approved a clinical trial sponsor or institution to conduct a clinical trial.

• Example(s):
  • United States Food and Drug Administration (FDA) Approval,
  • European Medicines Agency (EMA) Approval,
  • …
• Counter-Example(s):
  • Compassionate Use,
  • Emergency Use Authorization (EUA),
  • Microdosing Clinical Trial,
  • Illicit Drug Use,
  • Over-the-Counter Medication,
  • Right-to-Try Law.
• See: Approved Drug, Approved Medical Product, Applicable Clinical Trial, Clinical Trial Application, Clinical Trial Information System, Clinical Trial Management System, ICH E6 Good Clinical Practice (GCP) Guideline, Applicable Regulatory Requirement, Clinical Trial Protocol, Good Clinical Practice (GCP) Guideline.

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References

2021a

• (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research Retrieved:2021-11-14.
  • Approval (in relation to institutional review boards (IRBs))
    • 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)

2018

• (FDA, 2018) ⇒ FDA (2018). "E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry".
  • QUOTE: 1.5 Approval (in relation to institutional review boards (IRBs))
    • 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.

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