Glossary of Terms
- Subject/Participant/Volunteer: An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.
- Randomization: The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.
- Informed Consent: A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form.
- Informed Consent Form (ICF): A document approved by an authorized Institutional/Independent Review Board by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate.
- Institutional/Independent Review Board (IRB): And independent body constituted of medical, scientific, and nonscientific members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trials, protocols, amendments, and methods and materials to be used in obtaining and documenting informed consent of the trial subjects.
- Clinical Trial/Study: Any investigation in human subjects intended to discover or verify the clinical, pharmacological, and or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s) and/or to study absorption, distribution, metabolism and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.
- Investigational Product: A pharmaceutical form of an active ingredient or placebo being tested or used as a reference n a clinical trial including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication or when used to gain further information about an approved use.
- HIPAA: HIPAA is the acronym for the Health Insurance Portability and Accountability Act of 1996. They are required to establish national standards for electronic health care transactions and national identifiers for providers, health plans, and employers. It also addresses the security and privacy of health data.
- Investigator: A person responsible for the conduct of the clinical trial at the trial site. If a team of individuals at a trial site conducts a trial, the investigator is the responsible leader of the team and may be called the Principal Investigator.
- Sponsor: An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial.
- Protocol: A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial.