Glossary

In shaft seals, the casing containing the sealing material. Seal chamber for shaft seals.

Safe Threshold Value

Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g. associates, residents, research fellows).

An individual who participates in a clinical trial as either a recipient of the investigational medicinal product or as a control. (Synonyms: Patient, Volunteer)

An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.

An individual possessing in-depth knowledge of the particular subject based upon their education, training, and experience.

Those individuals with specific expertise in a particular area or field. Subject Matter experts should take the lead role in the verification of computerized systems. Subject Matter expert responsibilities include planning and defining verification strategies, defining acceptance criteria, selection of appropriate test methods, execution of verification tests, and reviewing results.

Those individuals with specific expertise in a particular area or field. Subject Matter experts should take the lead role in the verification of computerized systems.

Those individuals with specific expertise in a particular area or field. SME responsibilities include planning and defining verification strategies, defining acceptance criteria, selection of appropriate test methods, execution of verification tests, and reviewing results. (ASTM E2500-07)

A person who possesses a documented deep comprehension of the theory and concepts within his or her field of work.

(ASTM E 2500) Individuals with specific expertise and responsibility in a particular area or field (for example, quality unit, engineering, automation, development, operations, and so forth).

Trial subject identification number.

A listing of randomized identification numbers across the different treatment groups in a protocol or grouping of protocols. Use to associate with a unique subject or patient.

Synonyms: patient care, patient safety

Subject withdrawal is when subjects request that their data not be used for further research and that they not be contacted. Subjects that are off-treatment due to their own decision, due to side effects or at physician discretion, but have not withdrawn their consent are not subject withdrawals unless the subject specifically requests that they be withdrawn. Subject withdrawal usually requires written confirmation.

The process of vaporizing a solid substance by heat and then condensing it (without its having passed through a liquid state in either direction); a process of purification by separating the nonvaporizable impurities; a process analogous to the distillation of liquids.

An arc welding process that produces coalescence of metals by heating them with an arc or arcs between a bare metal electrode or electrodes and the work. A blanket of granular, fusible material on the work shields the arc. Pressure is not used and filler metal is obtained from the electrode and sometimes from a supplemental source (welding rod, flux, or metal granules).

An OAIS term. The agreement reached between an Archive and the Data Producer that specifies a data model for data submission. This data model identifies format/contents and the logical constructs used by the Data Producer and how they are represented on each media delivery or in a telecommunication session.

An OAIS term. An Information Package that is delivered by the Producer to an archive for use in the construction of one or several Archival Information Packages.

An OAIS term. An Information Package that is delivered by the Producer to an archive for use in the construction of one or several Archival Information Packages.

(IEEE) A separately compilable, executable component of a computer program. Note: This term is defined differently in various programming languages.

(IEEE) A routine that returns control to the program or subprogram that called it. Note: This term is defined differently in various programming languages.

(IEEE) A record of all or selected subroutines or function calls performed during the execution of a computer program and, optionally, the values of parameters passed to and returned by each subroutine or function. Synonymous: Call trace.

Replacement of one nucleotide in a DNA sequence by another nucleotide or replacement of one amino acid in a protein by another amino acid.

1. A compound that is altered by an enzyme.2. Food source for growing cells or micro-organisms.3. Material on which a sedentary organism lives and grows.