Glossaries

A trial design that allows a look at the data at particular time points or after a defined number of patients have been entered and followed up based on formulating a stopping rule derived from repeated significance tests. [Center for Advancement of Clinical Research]

Refers to the size of an information unit in relation to a whole. NOTE: Structuring "privileges" in electronic systems is said to be highly granular when each of many roles can differ in their capacity to act on electronic records.

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. NOTE: For Guidance on Good Clinical Practice see COMP/ICH/135/95; Declaration of Helsinki; 21 CFR 50, 21 CFR 54, 21 CFR 56, and 21 CFR 312. [ICH]

A collection of specialized words or terms with their meanings.

A single variable, usually a scale of ordered categorical ratings, which integrates objective variables and the investigator's overall impression about the state or change in state of a subject. [ICH E9]

The name of a drug based on its chemical and molecular structure. NOTE: In the United States of America, this is assigned by the United States Adopted Names (USAN) council. [After Merck Manual, Consumer Version, 2023] See also proprietary name, international nonproprietary name (INN), established name, medicinal product name, compendial name.

The extent to which the findings of a clinical trial can be reliably extrapolated from the subjects who participated in the trial to a broader patient population and a broader range of clinical settings. [ICH E9]

In the context of the Study Data Tabulation Model (SDTM), a higher level categorization of the subject-level observation domains. NOTE: Most CDISC domains are assigned to one of three general observation classes: 1) The Interventions general observation class is a domain that captures investigational treatments, therapeutic treatments, and surgical procedures that are intentionally administered to the subject (usually for therapeutic purposes) either as specified by the study protocol (e.g., exposure), coincident with the study assessment period (e.g., concomitant medications), or other substances self-administered by the subject (such as alcohol, tobacco, or caffeine). 2) The Events general observation class captures occurrences or incidents independent of planned study evaluations occurring during the trial (e.g., "adverse events" or "disposition") or prior to the trial (e.g., "medical history"). 3) The Findings general observation class captures the observations resulting from planned evaluations such as observations made during a physical examination, laboratory tests, ECG testing, and sets of individual questions listed on questionnaires. [Based on SDTM and SDTM Implementation Guide, www.CDISC.org] See also domain, event, intervention, finding. Compare with special purpose domain.

Therapy based on ex vivo or in vivo gene modification of cells using specific technologies, e.g., viral vectors and direct genome editing technologies. NOTE: A particular example of this is the therapy with gene-modified T cells (chimeric antigen receptor (CAR) T-cell therapies) used as immunotherapy in oncology. [After Natalie Mount, et al. Cell-based therapy technology classifications and translational challenge. Philos Trans R Soc Lond B Biol Sci. 2015 Oct 19; 370(1680): 20150017.] See also cell therapy, regenerative medicine therapy, regenerative medicine advanced therapy, biological product.

Subject self-identification re: masculine/feminine. [IOM] See also sex.