Glossaries

Any form of treatment that is introduced into the body slowly by constant administration or drip via a blood vessel, a muscle, or the spinal cord. [After EDQM Standard Terms controlled vocabularies for pharmaceutical dose forms Version 1.2.0 2019. Internal controlled vocabularies for pharmaceutical dose forms. Version 1.2.0 - 28 January 2019.] See also administration (substance).

An ongoing process that provides the subject with explanations that will help in making educated decisions about whether to begin or continue participating in a trial. informed consent is an ongoing, interactive process rather than a one-time information session. NOTE: Under 21 CFR 50.20, no informed consent form 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." In some cases, when the prospective subject is unable to provide legal consent, permission to participate may be obtained from a legally-authorized representative. See also consent form.

Data which in connection with other information can be used to identify an individual with high probability, e.g., age at baseline, race, gender, events, specific findings, etc. NOTE: two levels of indirect identifier are distinguished. Level 1 - not likely to change over time, is visible, and is available in other sources. Typically it is demographic data such as sex, age at a particular date, country, body mass index (BMI). Level 2 - longitudinal information that is likely to change such as measurements, events, age. See also quasi identifier. [PhUSE De-identification Standard for SDTM 3.2, version 1.0.1.]

A health problem or disease that is identified as likely to be benefited by a therapy being studied in clinical trials. NOTE: Where such a benefit has been established and approved by regulatory authorities, the therapy is said to be approved for such an indication.

A variable that is not affected by other variables that the study is trying to understand. Independent variables influence dependent variables. [After AMA Manual of Style] See also dependent variable.

An independent body (a review board or a committee, institutional, regional, national, or supranational) constituted of medical/scientific professionals and non-scientific members, whose responsibility it 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. NOTE: 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. [After ICH E6 R2 Glossary] See also institutional review board, ethics committee.

A committee established by the sponsor to assess at intervals the progress of a clinical trial, safety data, and critical efficacy variables and recommend to the sponsor whether to continue, modify, or terminate the trial. [ICH E9] See also data monitoring committee.

The criteria in a protocol that prospective subjects must meet to be eligible for participation in a study. NOTE: Exclusion and inclusion criteria define the study population. See also exclusion criteria.

A proportion calculated as the number of individuals who develop the disease during a period of time divided by the number of persons at risk. [After AMA Style Guide, 10th Edition; After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics, Lesson 3: Measures of Risk, CDC 2012] See also morbidity rate, morbidity, mortality, incidence, prevalence.

The occurrence of new cases of disease, injury, or disability in a defined population over a specified period of time. NOTE: Incidence is most often expressed relative to the total population at risk (i.e., per unit of population). [After Basic Epidemiology, R. Bonita and others, WHO 2006; After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics, Lesson 3: Measures of Risk, CDC 2012] Compare to prevalence. See also morbidity rate, morbidity, mortality, incidence rate.

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. [ICH]

A stage of disease in which there is reasonable likelihood that death will occur within a matter of months, or in which premature death is likely without early treatment. [21 CFR 312.300]