The investigator institution has the ultimate responsibility for the administration of an investigational product at the clinical site. A preventative (vaccine), a therapeutic (drug or biologic), a device, a diagnostic, or a palliative utilized in a clinical trial are all considered experimental products.
When used or assembled differently from the approved form, when used for an unapproved indication, or when used to learn more about an approved application, an experimental product may be either an unlicensed product or a licensed product. A product with a marketing authorization when used or built, a placebo being evaluated or used as a reference in a clinical investigation.
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