Study ConductGlossary Term
ICH E6(R3) Section 1.57
An individual who participates in a clinical trial, either as a recipient of the investigational product or as a control.
The subject or participant is the individual at the center of every clinical trial, the person whose voluntary participation makes clinical research possible. Whether receiving the investigational product, an active comparator, or placebo, each participant contributes to the scientific knowledge that may benefit future patients. The terms "subject" and "participant" are used interchangeably in clinical research, though "participant" has gained favor in recent years as it better reflects the voluntary nature of involvement and the partnership between researchers and those they study.
Participants may be patients with the condition under study, healthy volunteers in early-phase pharmacokinetic studies, or individuals at risk for developing a condition in prevention trials. Regardless of their health status, all participants share certain fundamental rights: the right to make an informed and voluntary decision about participation, the right to withdraw at any time without penalty, the right to confidentiality of their personal information, and the right to receive appropriate medical care for any adverse effects resulting from trial participation.
The recruitment and retention of appropriate participants is essential for generating meaningful trial results. Eligibility criteria must be designed to identify individuals who can safely participate and who are likely to provide data relevant to the research questions. Recruitment practices must be ethical and non-coercive, providing accurate information about both the potential benefits and risks of participation. Retention efforts must balance the scientific need for complete data collection against respect for participants' autonomy and well-being.
Enrollment
"After completing the screening assessments and signing the informed consent form, the individual was enrolled as a study participant and assigned a unique subject identification number."
Participant rights
"When the participant expressed concerns about continuing in the study, the coordinator reassured them that withdrawal was entirely voluntary and would not affect their standard medical care."
A procedure in which one or more parties involved in the trial are kept unaware of the treatment assignment to reduce bias in the assessment of outcomes.
A professional employed by the sponsor or contract research organization who monitors clinical trials at investigational sites to ensure protocol compliance, data quality, and participant safety.
A specialized research professional who works at the investigational site under the supervision of the investigator to coordinate and manage the day-to-day operational aspects of clinical trials.
The act of overseeing the progress of a clinical trial and ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, GCP, and applicable regulatory requirements.
Any change, divergence, or departure from the study design or procedures defined in the protocol that is not implemented through a formal protocol amendment.
ICH E6(R3) Section 1.57
An individual who participates in a clinical trial, either as a recipient of the investigational product or as a control.
The subject or participant is the individual at the center of every clinical trial, the person whose voluntary participation makes clinical research possible. Whether receiving the investigational product, an active comparator, or placebo, each participant contributes to the scientific knowledge that may benefit future patients. The terms "subject" and "participant" are used interchangeably in clinical research, though "participant" has gained favor in recent years as it better reflects the voluntary nature of involvement and the partnership between researchers and those they study.
Participants may be patients with the condition under study, healthy volunteers in early-phase pharmacokinetic studies, or individuals at risk for developing a condition in prevention trials. Regardless of their health status, all participants share certain fundamental rights: the right to make an informed and voluntary decision about participation, the right to withdraw at any time without penalty, the right to confidentiality of their personal information, and the right to receive appropriate medical care for any adverse effects resulting from trial participation.
The recruitment and retention of appropriate participants is essential for generating meaningful trial results. Eligibility criteria must be designed to identify individuals who can safely participate and who are likely to provide data relevant to the research questions. Recruitment practices must be ethical and non-coercive, providing accurate information about both the potential benefits and risks of participation. Retention efforts must balance the scientific need for complete data collection against respect for participants' autonomy and well-being.
Enrollment
"After completing the screening assessments and signing the informed consent form, the individual was enrolled as a study participant and assigned a unique subject identification number."
Participant rights
"When the participant expressed concerns about continuing in the study, the coordinator reassured them that withdrawal was entirely voluntary and would not affect their standard medical care."
A procedure in which one or more parties involved in the trial are kept unaware of the treatment assignment to reduce bias in the assessment of outcomes.
A professional employed by the sponsor or contract research organization who monitors clinical trials at investigational sites to ensure protocol compliance, data quality, and participant safety.
A specialized research professional who works at the investigational site under the supervision of the investigator to coordinate and manage the day-to-day operational aspects of clinical trials.
The act of overseeing the progress of a clinical trial and ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, GCP, and applicable regulatory requirements.
Any change, divergence, or departure from the study design or procedures defined in the protocol that is not implemented through a formal protocol amendment.