The specific medical and demographic criteria that must be met by subjects to be considered suitable for participation in the study. See also Screening
Independent Ethics Committee (IEC)
The Independent (Research) Ethics Committee (in Europe) is an independent body constituted of medical, scientific and non-scientific members whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a study by, among other things, reviewing, approving and providing continuing review of study protocol and amendments and of the methods used in obtaining and documenting informed consent of the study subjects. The equivalent body in North America or Japan is the Institutional Review Board (IRB).
The efficacy claims that are approved by the relevant government health agency for the medicine on the basis of the Core (Pivotal) Registration Studies. The indication is contained in the product label, also called prescribing information. The indications for a product may (and often do) differ by geography and country.
A process by which a participant voluntarily confirms his or her willingness to participate in a particular clinical study, after having been informed of all aspects of the study relevant to the participant's decision to participate, including known and potential risks and benefits. Informed consent is documented by means of a written, signed and dated informed consent form.
Institutional Review Board (IRB)
An independent body constituted of medical, scientific and non-scientific members whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a study by, among other things, reviewing, approving and providing continuing review of study protocol and amendments and of the methods used in obtaining and documenting informed consent of the study subjects. This term is used predominantly in North America and Japan. In Europe the equivalent body is the Independent (Research) Ethics Committee.
Investigational New Drug Application (IND)
After completing preclinical testing, a company files an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration to begin to test the drug in humans. The IND becomes effective if FDA does not disapprove it within 30 days. The IND shows results of previous experiments; how, where and by whom the new studies will be conducted; the chemical structure of the investigational drug; how it is thought to work in the human body; any toxic effects found in the animal studies; and how the compound is manufactured. All clinical studies must be reviewed and approved by the Institutional Review Board (IRB) or where the studies will be conducted in Europe, the Independent Ethics Committee (IEC)
An unapproved pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical study. See also Marketed Product.
A health care professional responsible for the conduct of a clinical study at a study site. If a team of individuals at a study site conducts a study, the investigator is the responsible leader of the team and may be called the principal investigator.
Investigators brochure (IB)
The Investigators Brochure (IB) is a compilation of clinical and non-clinical data for an Investigational Product relevant to its study in human subjects (whether a new product or a new use for the product). The IB provides information about the Investigational Product to theInvestigator, Study Site personnel, and IRB/IECs and aids the process of compliance with study protocols and the clinical management of Subjects enrolled in clinical studies. It is the key document used by some Regulatory Authorities for review of initial clinical study applications for a new chemical entity.