Approval (disambiguation)

This is a disambiguation page

Approval refers to a formal authorization, favorable opinion, or other official decision issued by a competent authority or organization. In clinical research, the term is used in several distinct contexts depending on the issuing body, applicable regulatory framework, and the activity being authorized.

The term does not have a single universal meaning and should be interpreted according to its context.

Meaning in clinical research

Common uses include:

• Ethics committee or institutional review roard (IRB) approval for the conduct of a clinical trial at a research site
• Regulatory authority approval for activities such as the initiation of a clinical trial, authorization of a clinical trial application, or marketing authorization of a medicinal product, depending on the applicable regulatory framework
• Sponsor approval or internal approval of study documents, protocol amendments, vendor selection, or other trial-related activities
• Approval of protocol amendments, informed consent forms, investigator brochures, and other essential documents by the appropriate reviewing authority

Because regulatory authorities use different terminology, the word approval may refer to different legal or administrative decisions in different jurisdictions. For example, some regulatory frameworks distinguish between an ethics committee’s favorable opinion and a regulatory authority’s authorization rather than describing both as approval.

See also

• Authorization
• Ethics committee
• Institutional review board (IRB)
• Regulatory authority
• Protocol amendment