adverse events	A medical complaint, change, or possible side effect of any degree of severity, that may or may not be attributed to the investigational product.
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 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.
CNS trials	Trials involving the central nervous system.
confidentiality	Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information of a subject’s identity.
controlled study	A study in which a test article is compared with a treatment that has known effects. The control group may receive no treatment, standard treatment, or placebo.
CRC	Clinical Research Coordinator. Person who handles most of the administrative responsibilities of a clinical trial, acts as liaison between investigative site and sponsor, and reviews all data and records before a monitors visit. Synonyms: trial coordinator, research coordinator, clinical coordinator, research nurse, protocol nurse.
CRO	Clinical Research Organization. An organization contracted by the Sponsor to conduct or monitor various aspects of the study.
Curriculum Vitae (CV)	Document that outlines a person’s educational and professional history.
efficacy	A product’s ability to produce beneficial effects on the course or duration of a disease.
effectiveness	The desired measure of a drug’s influence on a disease condition as proved by substantial evidence from adequate and well-controlled investigations.
FDA	Food and Drug Administration. The United States regulatory authority charged with, among other responsibilities, granting IND and NDA approvals.
GCP	Good Clinical Practice. A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
IND	Investigational New Drug Application. Also known as the Notice of Claimed Investigational Exemption for a new drug, this document provides sufficient data to establish that the drug has demonstrated a reasonable degree of safety that does not preclude its testing in humans.
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. (ICH) Under 21 CFR 50.20, no informed consent may include any “language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
investigational product	A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in 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. (ICH)
in vitro	Within a glass or observable in a test tube; referring to a process that takes place under artificial conditions or outside of the living organism. (From Latin; literally, “in glass.”)
NDA	New Drug Application. A comprehensive compilation of the documentation used to support the safe and effective used of a drug.
Principal Investigator (PI)	The individual, usually a physician, who is ultimately responsible for the conduct of the clinical investigation; the person under whose immediate direction the test article is administered or dispensed.
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, but these could be provided in other protocol reference documents.
Sponsor	The company or organization that is paying for the conduct of a clinical study; usually the pharmaceutical company whose drug is being tested.
Sub-Investigator	Any individual member if the clinical trial team designated and supervised by the Principal Investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows).

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