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Good Clinical Practice (GCP): 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.Healthy Volunteer: A healthy person who voluntarily agrees to participate in a clinical trial for reasons other than medical and receives no direct health benefit from participating.
ICH GCP: International Conference on Harmonization Tripartite Guideline for 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.
IEC: see Independent Ethics Committee
Inclusion Criteria: see Eligibility Criteria
IND: see Investigational New Drug
Independent Ethics Committee (IEC): An independent body (a review board or committee, institutional, regional, national, and supranational), constituted of medical/scientific professionals and non-medical/non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favorable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
The legal status, composition, function, operations, and regulatory requirements pertaining to Independent Ethics Committees may differ among countries, but should allow the Independent Ethics Committee to act in agreement with GCP as described in the ICH guideline.
Informed Consent: The process during which a subject learns all the details of a particular clinical trial such as study design, risks, benefits, etc. that would effect their decision to participate. Patients who agree to participate in a study are asked to sign and date an informed consent form, which describes this information about the study, after all their questions are answered. Signing the informed consent form confirms the patient's willingly volunteers to participate.
Institutional Review Board (IRB): An independent group of individuals including physicians, scientists, legal representatives, patient advocates and clergy whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by reviewing, approving, and providing continuing review of trials, protocols and amendments, and of the methods and material to be used in obtaining and documenting the informed consent. See Independent Ethics Committee.
Investigational New Drug (IND): An application submitted to the FDA for approval before any clinical trials involving the use of the investigational drug in humans can commence.
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.
Investigator: The person who is responsible for the proper conduct of the clinical trial at the trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.
IRB: see Institutional Review Board
None at this time.
None at this time.
Legally Acceptable Representative: An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial.
Life-Threatening: Refers to an event in which the patient was, in the view of the investigator, at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more serious.
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