Glossary

A living, non-virulent form of a micro-organism or virus that is used to elicit an antibody response that will protect the inoculated organism against infection by a virulent form of the micro-organism or virus. Also a living, non-virulent microorganism or virus that express a foreign antigenic protein and is used to inoculate humans or animals. The latter organisms are also called a live recombinant vaccines.

Documents maintained throughout the commissioning period as the system or project requirements are modified or updated.

Linear Low-Density Polyethylene

Local Lymph Node Assay

Linear Medium Density Polyethylene

Low Molecular Weight Heparin

As stress testing but to evaluate a system or component up to or at the limits of its specified requirements

A program which copies other (object) programs from auxiliary (external) memory to main (internal) memory prior to its execution.

Lowest-Observed-Adverse-Effect Level

Lab-on-a chip

A communications network that serves users within a confined geographical area. It is made up of servers, workstations, a network operating system, and a communications link.

Measures, such as hoods providing HEPA-filtered air or other appropriate devices, procedures, or equipment design features, to protect product from potential environmental contaminants.

A local subject is any subject that enrolled in a protocol at UVM / FAHC regardless of where they are being treated for the adverse event. Only if a subject has formally transferred to another center in a multi-center study (with a DSMB) is that subject no longer considered a local subject. All events on local subjects that meet the criteria must be reported to the IRB, regardless of where the event occurred, until the study has closed. The requirements apply to all studies that are open with the IRB. Adverse Events that occur after the study has been closed with the IRB need not be reported. Example: Assume a subject is enrolled in a study at UVM / FAHC and takes a vacation in another state. Any adverse events experienced by that subject while in the other state must be reported to the Committee as if he/she was still being treated locally.

The individual with accountability for the performance and compliance of the local implementation of the system. Responsibility for executing the associated activities is often delegated.

Determination of the original position (locus) of a gene or other marker on a chromosome.

An open process step or system that uses measures, such as hoods providing HEPA filtered air or other appropriate devices, procedures, or equipment design features, to protect product from potential environmental contaminants.

(OSHA 3120) Specific practices and procedures to safeguard employees from the unexpected energization or startup of machinery and equipment, or the release of hazardous energy during service or maintenance activities.

(OSHA 3120) Specific practices and procedures to safeguard employees from the unexpected energization or startup of machinery and equipment, or the release of hazardous energy during service or maintenance activities.

The position on a chromosome of a gene or other chromosome marker; also, the DNA at that position. The use of locus is sometimes restricted to mean regions of DNA that are expressed.

Limit of Detection

Loss on Drying

A statistical estimate of whether two loci are likely to lie near each other on a chromosome and are therefore likely to be inherited together. A LOD score of three or more is generally taken to indicate that the two loci are close.

Lowest-Observed Effect Level

(IEEE) Evaluates the safety-critical equations, algorithms, and control logic of the software design.