Definitions of Research Compliance Terms

Adverse Event (AE) – Any untoward event associated with a research study. The event does not necessarily have a causal relationship with treatment or study intervention. An AE can be any unfavorable and unintended sign, symptom or disease.

Advertising – One mechanism or method used by researchers to recruit subjects for research studies.

Alternatives – Options that exist for a subject who is thinking about participating in research.

Assent – Agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research.

Associated with the use of the Drug – There is a reasonable possibility that the experience may have been caused by the drug.

Assurance – See Federal Wide Assurance; and Multiple Project Assurance.

Authorized Institutional Official – See “Institutional Official.”