Adverse Drug Reaction (ADR): Any harmful or unintended response to a drug.

Adverse Event (AE): Any harmful or unintended effect possibly linked to a medicine or treatment.

Assent: When a volunteer agrees to participate in research, as required by federal law.

Blinding/Masking: When parties in a clinical trial are unaware of treatment assignments to reduce bias.

Clinical Protocol: Document detailing how a clinical trial is conducted, meeting scientific and ethical standards.

Clinical Trial/Study: Research to determine if a drug or treatment is effective.

Compensation: Money or value offered for study participation, excluding expenses.

Compliance: Following all trial requirements.

Confidentiality: Protecting information from unauthorized disclosure.

Disability: Significant disruption to normal life functions.

Guardian: Legally authorized to consent for volunteer’s medical care.

Human Subject: Living individual enrolled in a research study.

Informed Consent: Discussion and review of study details with prospective participants, documented by signing.

Institutional Review Board (IRB): Independent committee ensuring safety and rights of trial participants.

Intervention: Focus of a clinical study (e.g., drugs, devices, procedures).

Investigational New Drug (IND) Application: FDA approval needed to start a drug trial.

Investigational Device Exemption (IDE): FDA approval for device trials.

Investigational Product (IP): Substance tested in a trial (active or placebo).

Investigator: Person responsible for trial conduct (Principal Investigator).

Legally Authorized Representative (LAR): Authorized to consent for a subject in a trial.

Minor: Person under 18 years not married.

Minor Authorized to Consent: Person at least 16 years authorized to consent.

Multi-center Trial: Single protocol conducted at multiple sites.

Principal Investigator (PI): Responsible for all aspects of a clinical study.

Protected Health Information (PHI): Private information protected by law.

Protocol: Detailed plan for conducting a clinical trial.

Protocol Amendment: Written change(s) to a protocol.

Qualified Bilingual Assistant: Provides foreign language translation.

Randomization: Assigning trial subjects to groups by chance to reduce bias.

Regulatory Authorities: Bodies regulating clinical trials (e.g., FDA).

Research: Systematic investigation to develop knowledge.

Serious Adverse Event (SAE): Event resulting in severe outcomes.

Sponsor: Individual or organization initiating, managing, or financing a trial.

Sponsor-Investigator: Responsible for sponsor and investigator obligations.

Stipend: See Compensation.

Study Team Member: Assists with trial conduct.

Trial Site: Location of the clinical trial.

Witness: Independent person verifying informed consent process consistency.