Glossary

Adverse Event:

An untoward occurrence in patient or subject who is receiving a pharmaceutical product; may, or may not, have a causal relationship with treatment.

Autonomy:

Human right to self-government and freedom of choice; in clinical research refers to the subject’s right to give voluntary and informed consent to participate in a trial, to refuse to participate, or to withdraw at any time.

A Blinded (Masked) Study:

A study design comparing two or more treatments in which neither the investigator nor the participant knows which treatment has been assigned.

Case Report Form (CRF):

A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject.

Contract Resource Organization (CRO):

An organization hired by a sponsor to perform some, or all, activities involved in a clinical trial.

Control Participant:

A participant who receives placebo and/or standard treatment as a comparison to the treatment being studied.

Expected Adverse Event:

Describes an adverse event whose nature and severity are consistent with existing product labeling (or for investigational drugs, the Investigator’s Brochure).

Human Subject (Participant):

An individual who is, or becomes, a participant in research, and either receives the treatment being studied or the control. A participant may be either a healthy human or a patient.

Human Subjects Protection Office (HSPO):

The office designated to assist with the administrative process related to IRB research review.

Informed Consent Form (ICF):

A document prepared by the sponsor and the investigator for potential subjects which explains the clinical trial, including procedures and risks, to potential subjects.

Investigational (Experimental):

A term, which means a treatment (drug, device, procedure) that is unproven or not yet scientifically confirmed with respect to safety and effectiveness.

Investigator:

Works under supervision of the Principal Investigator: may perform clinical trial-related procedures; may act on behalf of the principal investigator, if required. Sub-Investigator is also does the same kind of work.

Investigator’s Brochure (IB):

A document provided by the sponsor and all investigators that compiles the clinical and non-clinical data on the investigational product (s) that is relevant to the study of the investigational product (s) in human subjects.

Institutional Review Board (IRB):

A special committee designated to review research involving human participants to make sure that the safety, rights and welfare of human participants in clinical research are protected. All research involving human participants must be approved by the IRB before the research may proceed.

Monitor:

Individual employed by the sponsor or the CRO hired by the sponsor: acts as a liaison between the sponsor and the investigator of a clinical study, and oversees the progress and conduct of the trial; may also be referred to as a CRA.

Multicenter Study:

Clinical trial in which identical research protocols are used at multiple trial sites or centers.

Outcomes Research:

Research into the value of medical treatments to society, providers, and patients, as measured by clinical, economical, and humanistic parameters.

Pharmacodynamics:

Study of the uptake, movement, binding, and interactions of a drug at its active site in the body.

Pharmacokinetics:

Study of the movement of a drug within a biological system, as affected by absorption, distribution, metabolism, and excretion.

Placebo:

An inactive substance (often referred to as a sugar pill) used to compare and or determine whether improvement and/or side effects reflect imagination or anticipation of the actual treatment.

Post-marketing Studies:

Clinical trials conducted after a drug is approved for marketing; equivalent to Phase IV of development process; usually compares the subject drug with other marketed drugs in its class or to fulfill requests for post-marketing surveillance of a product.

Principal Investigator:

The individual with primary responsibility for the conduct of the research.

Protocol:

A document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical trial.

Randomization –Randomized:

The process of assigning research participants to different treatment groups using an element of chance to determine the assignments in order to reduce bias.

Sponsor:

A person or entity that initiates a clinical investigation of a drug or device; usually the manufacturer or research institution that developed the drug or device.

Sub-Investigator:

Works under supervision of the Principal Investigator: may perform clinical trial-related procedures; may act on behalf of the principal investigator, if required.