Glossaries

A class of software applications for data extraction, transformation, and loading that are used to implement data interfaces between disparate database systems, often to populate data warehouses.

A variable of exposure taking into consideration the strength, dose, duration, frequency, route, and/or timing or gestational stage in utero and other factors. NOTE: Measures of concentrations in biological fluids and tissues may be used to attempt to quantify the extent of exposures (e.g., Cmax, Cmin, Css, AUC in pharmacokinetics or other exposure measurement and assessment models). [After, FDA Guidance for Industry Exposure-Response Relationships] See also exposure, exposure (individual), intervention.

For XML, an item of data provided in a mark-up mode to allow machine processing. NOTE: The mark-up or tagging facilitates document indexing, search and retrieval, and provides standard conventions for insertion of codes. [After Study Data Technical Conformance Guide, Technical Specifications Document, March 2019] See also XML (eXtensible Markup Language), Define-XML.

The result of an intentional contact (e.g., intervention, dosage, drug/product use, misuse, or abuse) or an unintentional contact (circumstantial events leading to unknown, inadvertent, or accidental contact) resulting in inputs to the body of an individual which can occur directly through primary bodily contact routes or indirectly through secondary contact routes (such as via fluids as in fetal exposure during pregnancy or lactation/breast feeding or other biological transfers). [After FDA, Reviewer Guidance Evaluating the Risks of Drug Exposure in Human Pregnancies] See also exposure, intervention, extent of exposure.

Contact between an agent and a target. A state of contact or close proximity to a medicinal product, chemical, pathogen, radioisotope or other substance. NOTE: Types of exposure may be described by many qualifiers (e.g., local, systemic, acute, chronic, cumulative, environmental, population, individual, gestational, or occupational.) See also exposure (individual), intervention, extent of exposure. [After International Programme on Chemical Safety (IPCS) 2004 WHO]

Phase 1 or 2 study during which the actions of a therapeutic intervention are assessed and measured. NOTE: Procedures in exploratory studies may appropriately be altered beyond the standard adequate and well controlled processes to expand the scope or method of investigation. [NOTE: After FDA eCOA Glossary] Compare to confirmatory study.

A clinical study that is conducted early in Phase 1; involves very limited human exposure and has no therapeutic or diagnostic intent (e.g., screening studies, microdose studies) [FDA Guidance for industry, investigators, and Reviewers: exploratory IND studies, January 2006] See also Phase 0.

A physical entity which is the primary interest in a specific research objective. NOTE: Depending on the research objectives, a single study may have multiple levels of experimental units. Commonly the individual study subject (animal, person or product) is the experimental unit. (BRIDG v5.3)

The drug, device, therapy, procedure, or process under investigation in a clinical study that is believed to have an effect on outcomes of interest in a study (e.g., health-related quality of life, efficacy, safety, pharmacoeconomics). NOTE: This does not include comparators or placebos. [After https://grants.nih.gov/grants/policy/faq_clinical_trial_definition.htm#5224; https://grants.nih.gov/policy/clinical-trials/protocol-template.htm] See also test articles, devices, drug product, combination product, treatment, diagnosis, investigational medicinal product.

A predominantly First-in-Human (FIH) trial with a single protocol with an initial dose-escalation phase followed by three or more additional subject cohorts with cohort-specific objectives. NOTE: The objectives of these expansion cohorts can include assessment of antitumor activity in a disease-specific setting, assessment of a dose with acceptable safety in specific populations (e.g., pediatric or elderly subjects, subjects with organ impairment, subjects with specific tumor types), evaluation of alternative doses or schedules, establishment of dose and schedule for the investigational drug administered with another oncology drug, or evaluation of the predictive value of a potential biomarker. In general, comparison of activity between cohorts is not planned except when a prespecified randomization and analysis plan are part of the protocol design. [FDA Guidance: Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry. March 2022]

The act or process of eliminating waste products from the body. See also ADME.

List of characteristics in a protocol, any one of which may exclude a potential subject from participation in a study.

Planned protocol activities such as randomization and study completion, and occurrences, conditions, or incidents independent of planned study evaluations occurring during the trial (e.g., adverse events) or prior to the trial (e.g., medical history). [After SDTM, www.cdisc.org] See also general observation class, intervention, finding.

Pertains to data or subjects that meet Statistical Analysis Plan criteria for inclusion in efficacy/safety datasets.

The regulatory agency for the EU.