Subject

While all patients in a clinical trial are trial subjects, not all trial subjects are patients, as some may be healthy volunteers.

A subject (also referred to as a human subject, trial subject, healthy subject, patient, or participant) is an individual who participates in a clinical study, either as a recipient of the investigational product or as a control. This includes individuals suffering from a specific disease under study or healthy participants volunteering in the trial.

Definitions

ICH E6(R2)

1.57 Subject/Trial Subject:

An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control .

Regulatory standards for clinical trial participant protection

Regulatory definitions and requirements for subjects in clinical trials can vary worldwide, yet all of them emphasize voluntary participation, well-being, and safety monitoring.

• In the United States, the FDA enforces specific guidelines and protections for trial subjects under regulations such as 21 CFR Part 50, which addresses the protection of human subjects.
• In the European Union, the protection of trial subjects is enforced by the European Medicines Agency (EMA) under the Clinical Trials Regulation (EU) No 536/2014.

Other regions, such as Japan and Canada, also have their own regulatory frameworks to ensure the ethical treatment and safety of trial subjects.

Distinctions between patients subject, and trial participant

The terms patient, subject, and trial participant, while often used interchangeably, have distinct meanings.

• A patient specifically refers to an individual who receives medical care or treatment for a particular condition. In clinical trials, patients are typically those who have the disease or condition being studied.
• A subject or trial subject is a broader term encompassing any individual participating in a clinical study, regardless of their health status.
• A trial participant is a lay term often used in documents like informed consent form, or plain language summaries of study results, publication .

	Patient	Subject	Trial Participant
Regulatory recognition	Considered under the specific context of their disease and treatment	Defined broadly in regulations, guidelines, clinical databases	Lay term, recognized in a general sense, inclusive of both subjects and patients
Health status	Typically has the disease or condition being studied	Can be a healthy volunteer or a patient	Can be a healthy volunteer or a patient

See also

Links to this page

• Plain language summary of study results ‎ (← links)
• Subject identification code ‎ (← links)
• Vulnerable subjects ‎ (← links)
• Well-being ‎ (← links)
• Clinical trial registry ‎ (← links)
• 45 CFR 46 ‎ (← links)