Definition

Any investigation in human subjects intended to discover or verify effects of one or more medicinal products. Requires regulatory and ethics approval.

Example

Phase 1–3 trials are clinical trials; they must have an approved protocol, informed consent, and oversight.

Regulatory source

EU Regulation 536/2014, 21 CFR 312, ICH E6

Common mistakes

Conducting trial activities before approvals. Not reporting serious breaches or SUSARs in line with regulations.

Inspector question

How do you ensure all trial activities are covered by approved protocol and consent?

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