Glossary

A structured software design technique in which system structure is derived from analyzing the flow of data through the system and the transformations that must be performed on the data.

1. The uptake and establishment of DNA in a bacterium or yeast cell, in which the introduced DNA often changes the phenotype of the recipient organism.2. Conversion by various means of animal cells in tissue culture from controlled to uncontrolled cell growth. Typically through infection by a tumour virus or transfection with an oncogene.

A gene from one genome that has been incorporated into the genome of another organism. Often refers to a gene that has been introduced into a multicellular organism.

An organism formed by the insertion of foreign genetic material into the germ line cells of organisms. Recombinant DNA techniques are commonly used to produce transgenic organisms.

The alteration of a plant or animal’s DNA such that it contains a gene from another organism. There are two types of cells in animal and plants, germ line cells (the sperm and egg in animals, pollen and ovule in plants) and somatic cells (all other cells). Transgenic animals have alterations in their germ line DNA so the alterations are passed on to the offspring. That is done to produce therapeutics, to study disease, and to improve farm animals. Transgenic plants have been created for increased resistance to disease and insects as well as to make biopharmaceuticals.

Of short duration.

This data is not an electronic record under Part 11 due to its "fleeting" nature. Such data may not be stored at all; e.g., it can be a direct signal from a detector to an A/D converter. Alternatively, it can be stored temporarily in a variety of manners. For example it can reside solely in a computer's RAM, or it can be stored to a computer's virtual memory, i.e., written to hard disk in temporary files that are automatically deleted by the end of the current computer session. Transient data is unalterable by the user while it remains in memory. Transient data may be sent to a printer, processed further by the system, or transmitted to another computer system. It may be used by the system without ever being stored; e.g., as input for a feedback loop in a control system, or it could ultimately become part of an electronic record.

The substitution in DNA or RNA of one purine by another purine, or of one pyrimidine by another pyrimidine.

A device subject to section 520(l) of the act, that is, a device that FDA considered to be a new drug or an antibiotic drug before May 28, 1976.

(NIST) Converting from one language form to another.

The process in which the genetic code carried by mRNA directs the synthesis of proteins from amino acids.

Breakage and removal of a large segment of DNA from one chromosome, followed by the segment's attachment to a different chromosome.

A set of communications protocols developed for the Defense Advanced Research Projects Agency to internetwork dissimilar systems. It is used by many corporations, almost all American universities, and agencies of the federal government. The File Transfer Protocol and Simple Mail Transfer Protocol provide file transfer and electronic mail capability. The TELENET protocol provides a terminal emulation capability that allows a user to interact with any other type of computer in the network. The TCP protocol controls the transfer of the data, and the IP protocol provides the routing mechanism.

The process whereby a transposon or insertion sequence inserts itself into a new site on the same or another DNA molecule. The exact mechanism is not fully understood and different transposons may transpose by different mechanisms. Transposition in bacteria does not require extensive DNA homology between the transposon and the target DNA. The phenomenon is therefore described as illegitimate recombination.

A transposable or movable genetic element. A relatively small DNA segment that has the ability to move (mobile genetic element) from one chromosomal position to another, e.g., Tn 5 is a bacterial transposon that carries the genes for resistance to the antibiotics neomycin and kanamycin and the genetic information for insertion and excision of the transposon.

The provision of health care by one or more health care providers. Treatment includes any consultation, referral or other exchanges of information to manage a patient's care. The Privacy Notice explains that the HIPAA Privacy Rule allows Partners and its affiliates to use and disclose protected health information for treatment purposes without specific authorization.

An Investigational New Drug (IND) that makes a promising new drug available to desperately ill patients as early in the drug development process as possible. FDA permits the drug to be used if there is preliminary evidence of efficacy and it treats a serious or life-threatening disease, or if there is not comparable therapy available.

Treatment Identification Number assigned to the subject according to the randomization schedule and that relates to the investigational medicinal product(s) contained in the kit.

A sugar (non-reducing disaccharide) found in certain algae and plants, some bacteria, and some insects. It is used as a preservative and stabilizer in some biopharmaceutical formulations.

(ICH Q9) A statistical term referring to the direction or rate of change of a variable(s).

Toxics Release Inventory

Identification code of the trial site, investigator, and sponsor. (Synonyms: Trial ID, Protocol Number, Study Name, etc.)