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Terms Abbrv. Definition Remarks
Impartial Witness A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject. GCP
In vitro Testing Testing or action outside an organism (e.g. inside a test tube or culture dish) US Environmental Protection Agency. Glossary I. Available at: http://www.epa.gov/OCEPAterms/iterms.html.
In vivo Testing Testing or action inside an organism, such as a human subject or patient. US Environmental Protection Agency. Glossary I. Available at: http://www.epa.gov/OCEPAterms/iterms.html.
Independent Data-Monitoring Committee (Data and Safety Monitoring Board, Monitoring Committee, data Monitoring Committee) IDMC An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial. GCP
Independents Ethics Committee IEC An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical/scientific professionals and non-medical/non-scientific members, whose responsibility is to ensure 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 favourable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be in obtaining and documenting informed consent of the trial subjects. GCP
Informed Consent A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having being 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. GCP
Participation in the clinical trial is voluntary and the participant may withdraw from the trial at any time without penalty or loss of benefits to which he/she is otherwise entitled. The research team actively maintains informed consent throughout the trial by providing the participant with any new or developing information. acrohealth
This verification is requested only after complete, objective information has been given about the trial, including an explanation of the study’s objectives, potential benefits, risks and inconveniences, alternative therapies available, and of the subject’s rights and responsibilities in accordance with the current revision of the Declaration of Helsinki.
Informed Consent Document A document that describes the rights of the study participants, and includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant will be asked to sign this document if they agree to participate in the trial. The informed consent document is not a contract. Participation in the clinical trial is voluntary and the participant may withdraw from the trial at any time without penalty or loss of benefits to which he/she is otherwise entitled.
Inspection The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial, at the sponsor’s and/or contract research organization’s (CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies).
Interactive Voice Response System IVRS a tool where telephone is used as a device to input information. It is entirely automated. Usually used in Remote Patient Randomization, Dispensing pharmaceuticals drugs at sites for clinical trials according to need and type of clinical trial, record complete clinical trial data about the recruitment of subjects and their details for future reference, maintain a record of amount of pharmaceutical drugs dispensed, amount used, result of a particular experiment and then disseminating this information to parent organization.
Institution (medical) Location of research. Retains ultimate responsibility for human subject regulation compliance. Any public or private entity or agency or medical or dental facility where clinical trials are conducted.
Institutional Review Board IRB An independent body constituted of medical, scientific, and non-scientific members whose responsibility is to ensure the protection of rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments of the methods and material to be used in obtaining and documenting informed consent of the trial subject. Every institution that conducts or supports biomedical or behavioral research involving human participants must, by federal regulation, have an IRB that approves and periodically reviews the research in order to protect the rights of human participants.
Intent to Treat Analysis of clinical trial results that includes all data from participants in the groups to which they were randomized even if they never received the treatment.
Interim Clinical Trial/ Study Report A report of Intermediate results and their evaluation based on analyses performed during the course of a trial.
International Conference on Harmonization ICH A forum that brings together the regulatory authorities of Europe, Japan, and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. The ICH makes recommendations on ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.
Intervention Name The generic name of the experimental treatment being studied.
Interventions Primary experimental treatments being studied. Types of treatments may include drug, gene transfer, vaccine, behavior, device, or procedure.
Investigational Device Exemption IDE Exemption from FD & C Act to study investigational medical devices.
Investigational New Drug Application IND The petition through which a drug sponsor requests the FDA to allow human testing of a new drug, antibiotic drug, or biological drug in a clinical investigation. This includes an application for a biological product used in vitro for diagnostic purposes
Investigational Product A pharmaceutical form of an active ingredient including plant/animal derived medicinal products 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 to gain further information about an approved use. Device?
Investigator A person responsible for the conduct of the clinical trial at 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 principle investigator. See also subinvestigator.
Investigator meeting Meeting at which the pharmaceutical sponsor of a study brings together all participating investigators to review study procedures and activities and provides an opportunity for questions and clarification.
Investigator/Institution An expression meaning “the investigator and/or institution, where required by the applicable regulatory requirements”.
Investigator’s Brochure IB A compilation of the clinical and non-clinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects. Relevant clinical and non-clinical data compiled on the investigational drug, biologic or device being studied.
Last subject out/complete LSC/LPC LPO/LSO The last patient to complete a trial (all data collected), a planned or achieved milestone marked by a date and 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 Disease or condition where the likelihood of premature death is high or will occur within a matter of months or days unless the course of the disease is interrupted.
Longitudinal study A study conducted to measure changes over a long period of time